Bogota Drugstore Quality Management System

QUALITY MANAGEMENT SYSTEM MAZUERA DRUGS and
Peusanda in your Health!

MAZUERA DRUGS
■—
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MADE BY: LADY MARIA ZAPATA QUIMBAYO
DATE OF ISSUE LAST DATE VERSION 1 ©300 87g 7830
Calle 175 No G3 41 B Villa del Prado
INITIAL: UPDATE:
SEPTEMBER 2018 SEPTEMBER 2018
QUALITY MANAGEMENT SYSTEM
MAZUERA DRUGS

DATE OF ISSUE LAST DATE VERSION 1
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TABLE OF CONTENTS
TABLE OF CONTENTS
1 DESCRIPTION OF THE ESTABLISHMENT
1.1 INTRODUCTION
1.2 HISTORICAL REVIEW
1.3 VISION
1.4 MISSION
1.5 PRINCIPLES AND VALUES
1.6 WORK ENVIRONMENT
2 OBJECTIVES AND SCOPE
2.1 AIM
2.2 SCOPE
3 DESIGN AND DEVELOPMENT 10
4 GENERAL REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM 10
5 CUSTOMERS 12
6 SUPPLIERS 12
7 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 13
7.1 INTERNAL STRUCTURE 13
MADE BY: LADY MARIA ZAPATA QUIMBAYO 17
8 STRATEGIC QUALITY FRAMEWORK QUALITY POLICIES 19
SWOT MATRIX 19
8.3 DOCUMENTATION 20
PROCESS MANAGERIAL 22
PROCESS OF PROVISION OF 22
SERVICES 22
PROCESS OF SALES 22
PROCESS ADMINISTRATIVE 22
PROCESS FINANCIAL 22
TICKETS 23
MANAGEMENT PROCESSES 25
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10 CUSTOMER FOCUS 25
10.2 PROMOTION AND PREVENTION CAMPAIGNS 26
11 PURCHASES 26
12 CONTROL OF MEASUREMENT AND MONITORING INSTRUMENTS 26
13 INFORMATION ANALYSIS AND IMPROVEMENTS 26
14 RISK MATRIX 27
What is risk? 27
How is risk identified? 27
HOW IS IRRIGATION ANALYZED? 27
RISK ASSESSMENT 29
APPENDIX 2 34
CUSTOMER SERVICE PROCEDURE, RECEPTION AND PQRS PROCESSING 34
AIM 34
DEFINITIONS 34
DESCRIPTION 34
SUGGESTIONS, COMPLAINTS AND CLAIMS 34
Addressjsin/Cost 39
INFORMATION ON THE PROPER USE OF MEDICATIONS 39
STORAGE 39
RECONSTITUTION 39
AGAINST ADVERSE REACTIONS 39
ANNEX 9 44
INTERNAL AUDIT PROCESS 44
AIM 44
SCOPE 44
DEFINITIONS 44
DESCRIPTION 44
CORRECTIVE, PREVENTIVE AND CHANGE CONTROL ACTION
PROCEDURES 50
AIM 50
DEFINITIONS 50
SCOPE 50
DESCRIPTION 50
SCOPE 52
DESCRIPTION OF ACTIVITIES 52
3. TRAINING 52
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4. PROCEDURE. 53
SCOPE 56
DEFINITIONS 56
REPORTING OF ADVERSE REACTIONS 58
PROCEDURE 58
INSTRUCTIONS FOR COMPLETING THE SUSPECTED EVENTS FORM
ADVERSE TO MEDICINE (FOREAM) 66
1. REPORTER INFORMATION 66
2. INFORMATION OF THE PATIENTE 66
Sex: mark with an x in the corresponding box: M (male) F (female), S/I (no
information) 66
3. MEDICATION INFORMATION 67
4. ADVERSE EVENT INFORMATION: 67
GENERAL RECOMMENDATIONS FOR NOTIFICATION 68
INFORMATION FOR SENDING PHYSICAL REPORTS: 68
INFORMATION FOR REPORTING ADVERSE EVENTS THROUGH THE ONLINE
FOREAM FORMAT: 68
2. SCOPE 69
3. GLOSSARY 69
4. RESPONSIBLE 69
5. GENERAL CONDITIONS 69
INFORMATION ON THE PROPER USE OF MEDICATIONS 77
GENERAL RECOMMENDATIONS 77
DOSAGE 77
STORAGE 77
RECONSTITUTION 77
REPORTING ADVERSE REACTIONS 77
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1 DESCRIPTION OF THE ESTABLISHMENT
1.1 INTRODUCTION
The quality management system of the MAZUERA drugstore is implemented, based on continuous
improvement, where it systematically seeks to optimize the performance of the provision of pharmaceutical
product dispensing services and the relationship with clients and suppliers.
This manual describes the provisions adopted by the establishment to comply with our policies, objectives, legal,
contractual and regulatory requirements related to quality, as well as the requirements demanded in NTC ISO
9001, seeking development and control of all activities related to quality. quality of our service.
1.2 HISTORICAL REVIEW
The MAZUERA drugstore is a company dedicated to the marketing of medicines and personal care products,
located at 175 street # 63-41 in the city of Bogotá. Created 25 years ago by Mr. Mario Díaz, who died two years
ago and was left in charge of his wife, Mrs. Graciela Moyano, then he sold it to the current owner, Mr. Jorge
Camelo, and since then, Mr. Jorge Camelo has been the administrator.
Currently, the drugstore has recognition in the sector and is preferred by people for its history in the sector. In
order to comply with the infrastructure requirements determined for establishments in the pharmaceutical sector,
promote and strengthen the pharmaceutical market in its area of influence.
The MAZUERA drugstore currently has a point of sale, designed and adequate, according to resolution 14'3 of
2007, enabled by the Secretary of Health of Bogota.
The MAZUERA drugstore is an establishment committed to the continuous improvement of its processes, which
results in the quality and timeliness of the service provided to all its clients.
1.3 VISION
The MAZUERA drugstore will be a leading company in the market, maintaining its competitiveness, focusing its
service on good treatment and respect for the customer and on the quality and suitability of its service, as well
as the search for better products with attractive alternatives. that ensure the generation of value for our clients.
1.4 MISSION
The MAZUERA drugstore works to improve the quality of life of the population, efficiently using the human,
physical and financial resources it has, thus satisfying the requirements of both our clients, our workers and
suppliers; through the marketing of
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medicines, hygiene products, cosmetics and medical supplies, guaranteeing the highest standards of quality,
efficiency, good service and competitiveness, ensuring the sustained and profitable growth of our establishment
and always providing health and well-being to the community.
1.5 PRINCIPLES AND VALUES
INTEGRITY – HONESTY – TRUST: as fundamental conditions to achieve the success of our efforts.
RESPONSIBILITY: we have a high commitment to compliance with our work and social responsibilities, always
responding on time with anxiety and enthusiasm.
TEAMWORK: we are a group of people dedicated to making things happen, that is why we share our
knowledge, risks and successes, always accepting the challenge of forming a comprehensive team of excellent
human qualities.
EXCELLENCE: providing the best of each of us in order to achieve and exceed the proposed goals day by day,
foreseeing and continually improving.
1.6 WORK ENVIRONMENT
The MAZUERA drugstore has identified the optimal requirements for the work environment and facilities, in
order to ensure a positive work environment, which provides staff with the necessary motivation to achieve good
performance in the development of their activities, for which The following conditions are identified.
CONDITIONS: (Space, lighting, temperature). Our point of sale has natural lighting through windows, artificial
lighting through lamps, hallways with space that favors the free movement of all staff. Ventilation guarantees
optimal storage and preservation conditions for products and allows the normal development of the functions of
all workers.
CONDITIONS OF HYGIENE, SAFETY AND CLEANLINESS: awareness campaigns have been carried out on
the importance of preserving adequate hygienic-sanitary conditions. Which are maintained through cleaning and
order activities carried out daily, which are recorded in the hygiene and area disinfection registration form. It also
has pest control and drinking water storage tank washing.
2 OBJECTIVES AND SCOPE

2.1 AIM
Describe the quality control system of the MAZUERA drugstore, by clearly and precisely defining the
processes, presenting the quality policy. Furthermore, with the application of the quality management
manual, achieve greater productivity and continuous improvement in the quality of the services provided to
its clients, based on resolution 1403 of 2007 and the ISO 9001:2008 standard.
2.2 SCOPE
The quality control system of the MAZUERA drugstore applies to the marketing of pharmaceutical
products and medical-surgical supplies, providing guidelines and instructions that allow all the
establishment's processes to meet standards established in resolution 1403 of 2007.
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Decree 2200/2005, Resolution 1164 of 2002, ISO 9001:2008 standard and other standards that regulate
the marketing activity of related pharmaceutical products.
3 DESIGN AND DEVELOPMENT
The MAZUERA drugstore did not modify its services or products already defined previously, it only made an
adjustment to its processes and services to the regulatory requirements and needs of its clients.
This QUALITY MANUAL is written with the objectives of supporting the QUALITY MANAGEMENT SYSTEM and
defining the policy of the MAZUERA drugstore, with regard to the quality of its processes and its final products.
Its knowledge and strict application is mandatory for all those who have any responsibility in the handling of our
products, within a broad process that ranges from selection and acquisition to the satisfactory use of our
products or services by our clients.
The quality policy and quality objectives of the MAZUERA drugstore are complemented by the Mission, Vision
and values statements that are also indicated in the Manual and that have been established by consensus and
with approval of the technical director of the establishment.
This provides a framework for the implementation and review of the organization's objectives through the
commitment to compliance with the requirements and the continuous improvement of the effectiveness of the
quality management system.
4 GENERAL REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM
The establishment documents, implements and maintains the quality management system, as well as its
continuous improvement, through the activities described in the characterization of the processes attached to
the Processes and Procedures Manual, such as:
either Selection
either Acquisition
o Technical Reception
either Storage
either Dispensing
either Control of environmental conditions
either PGIR
In the same way, the necessary methods and controls are determined through the characterizations of
processes with management indicators ( ANNEX 1), which provide results that allow measuring the results of
the system, as well as with monitoring, inspections, scheduled internal audits, reports. of results of feedback
from our clients. As a result of these monitoring, the necessary actions are implemented to achieve the planned
results and the continuous improvement of the processes, aimed at improving the effectiveness of the quality
management system.
Its owner guarantees the availability of the necessary resources for the implementation of the quality
management system and is available, as manager and technical director, to disseminate the information to the
entire
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personnel in charge concerning the QMS such as: procedures, controls and guidelines established for the
execution of the processes described therein.
5 CUSTOMERS
The MAZUERA drugstore is focused on promptly meeting the needs of retail clients, who reside in areas
surrounding its point of sale, among whom are patients with different pathologies for which both generic and
brand-name medications are available according to the request.
6 SUPPLIERS
The MAZUERA drugstore selects its suppliers by doing a historical analysis of variables such as: product
quality, timeliness of delivery, cost, among others.
For this version, the following suppliers were selected, of which there is a respective health concept issued by
the corresponding health authority that is less than one year old ( annex 18).
or UNIDROGAS
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QUALITY MANAGEMENT SYSTEM ■—

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7 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
To determine the levels of authority, the internal structure has been defined and within each process they have
been established in the different documents for each activity to be carried out and in the description of the
functions inherent to each position, which have been disseminated, distributed and controlled for effective
compliance.
7.1 INTERNAL STRUCTURE
The MAZUERA drugstore is organized as follows.

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QUALITY MANAGEMENT SYSTEM MAZUERA DRUGS
MAZUERA DRUGS I'm sorry for your
health!
INITIAL: UPDATE:
£300 87= 783=
Calle 175 No 63 41B Villa del Prado
POST REQUIREMENT FUNCTIONS
OWNER either Provide financial resources for the implementation of all your processes.
either Conduct marketing studies
either Organize the personnel under your charge.
either Perform supplier selection
either Guarantee the timely supply of merchandise
either Carry out periodic training for the personnel under your charge
either Carry out periodic inventories
either Supervise that measuring equipment and instruments are calibrated and in optimal
condition.
conditions for its correct operation (refrigerators, thermometers, thermo-hygrometers, among
DIRECTOR either Dispense and supervise the dispensing of pharmaceutical products, medical devices,
TECHNICAL ■ Pharmacy manager or person phytotherapeutic products, dietary supplements, cosmetics and others
accredited as a medicine dispenser. either Supervise that the storage conditions of these guarantee their conservation,
■ Minimum experience of 1 year in stability and quality.
driving of establishments either Report suspected adverse reactions
pharmacists. either Carry out technical reception of the entered products.
■ Product knowledge either Report any anomaly that occurs during the development of your duties.
marketed pharmaceuticals. either File documentation, returns format and other where applicable.
■ Knowledge in normativity either Maintain order of equipment and work sites
current applied to pharmaceutical either Check medication list and expiration dates.
establishments. either Participate in scheduled training.
DRUGSTORE ■ Knowledge in driving of either Classify and organize pharmaceutical products on shelves, according to the pre-established
ASSISTANT medications, classification order and
■ Business skills. place order orders according to shortages.
■ Good interpersonal relationships. either Serve clients.
either Promote products.
either Organize exhibition showcases.
either Keep the shelves in a good state of cleanliness and order.
either Be aware of the date of expiration.
health!
health!
DATE OF ISSUE LAST DATE VERSION 1 £300 87= 783=
INITIAL: UPDATE:
MAZUERA DRUGS
health!

DATE OF ISSUE LAST DATE ©300 VERSION
87g 7830 1
INITIAL: UPDATE: Calle 175 No G3 41 B Villa del Prado
8 STRATEGIC QUALITY FRAMEWORK QUALITY POLICIES

8.1 Offer friendly, cordial and timely service to all our clients. Have excellent quality products
1. Have trained personnel.
2. SWOT MATRIX
3.
8.2 Objective: identify and analyze strengths and weaknesses, as well as opportunities and threats.
Market positioning
Although they have a Competitive prices Sale of
wide product portfolio, it high quality products.
could be broader Little
advertising
Increase in competition
Arrival of large stores
specialized in the
pharmaceutical market
Decrease in the purchasing
■ Possibility of expansion. V power of the population.
MAZUERA DRUGS

DATE OF ISSUE LAST DATE VERSION 1©300 87g 7830
MAZUERA DRUGS and

T Peusanda in your Health!
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8.3 DOCUMENTATION
The QMS documentation will be organized as follows:
PROCESS CHARACTERIZATION: documents that establish specifications and/or requirements for a certain
MAZUERA DRUGS

process.
©300 87g 7830
OTHER DOCUMENTS: documents that support standardization and provide information about a process.
RECORDS: documents that provide objective evidence of the activities carried out or results obtained. ANNEX
(17)
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DATE OF ISSUE LAST DATE
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VERSION 1
8.4 PROCESS CHARACTERIZATION
8.4.1 PROCESS MAP
The processes carried out in the establishment that

are directly related to the quality management
system are the following:
n
-
PROCESSES OF
MANAGEMENT
QUALITY
- Design,
implement and
evaluate quality
management
system
PRO dec the

CESS isio man
MA ns age
NAG - St ment
ERIA rate syste
L gic m
- M dire
ake ctio
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PRO eco P
CESS no R
-
OF mic -
PRO acti -
VISI vity -
ON of P
OF the R
-
S co
ERVI -
mp
CES any
-In
char - S
ge of ear
provi ch
ding for
a pos
frien sibl
dly, e
timel mar
y ket
and s
quali - A
ty dve
servi rtisi
ce ng
that and
satis sale
fies s
the stra
need tegi
s of es.
cust - G
omer uar
s ant
PRO ee
CESS pur
OF
cha
SAL
se
ES
of
- M pro
anag duc
es ts
the
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An analysis of the most relevant processes of quality management was carried out with the PHVA
(Plan, Do, Verify and Act) cycle, identifying the necessary documentation for each process.
8.4.2 PHVA CYCLE
PHVA
TO PLAN
V Marketing studies
V Purchases from suppliers
TICKETS
V Demand projection
V Advertising and
promotions
DO
-Demand V Analysis and decision

projection making - Positioning
V Prepare demand - New products
- Budget projection - Customers
V Order Schedule satisfied
- Historical facts
V Strategic Marketing - New markets
Plan - Promotion
- Business - advertising
necessities VERIFY
V Internal control
V Demand behavior
SUPPLIERS V Audits
V Advertising and
DEPART
promotions effectiveness
URES
ACT
CUSTOM
ERS
V Continuous
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health!

SALES PROCESS
RESOURCE
DOCUMENTATION INDICATIONS
- HumansS
- Previous studies Customer satisfaction
- Stationery
- demand Demand coverage
projection - Computer and office
equipment
- sales forecast - Acceptance of
merchandise
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health!

8.4.3 PROCESS MAP
MANAGEMENT PROCESSES
Planning/
measurement/
Satisfaction of
the custo
mer
MISSIONAL PROCESSES
MAINTENAN RESOURC MANAGEM

CE ENT E
HUMAN ENT
QUALITY
SUPPORT PROCESS
Records control documents are considered those that prove the performance of a certain activity and are
used to evaluate, from a quality point of view, the history of activities carried out.
The records must have physical support, and are controlled in accordance with the procedures established in
the processes and procedures manual, which establishes the conditions for the maintenance of internal
records that provide evidence of compliance with the requirements. (ANNEX17).
10 CUSTOMER FOCUS
The establishment demonstrates through the implementation of its QMS that the opinions and needs of its
clients are identified through satisfaction surveys and the receipt of suggestions, requests, complaints and
claims, as well as establishing the processes with which these requirements are met.
MAZUERA DRUGS FO ORQGUERIS i Peusanda in your
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DATE OF ISSUE LAST DATE VERSION1 Villa del Prailo
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10.1 COMMUNICATION WITH THE CUSTOMER
The following communication methods have been implemented:
Direct attention and processing of suggestions, requests, complaints and claims in accordance with the provisions
of the PQRS reception and processing procedure (ANNEX 3).
10.2 PROMOTION AND PREVENTION CAMPAIGNS
MAZUERA Pharmacy is committed to the health of our clients not only in a curative way, but also in a preventive
way, which is why it develops campaigns to promote healthy living habits, proper use of medications and medical
devices, foresee risk factors derived of its use, among others. For which I designed an informative flyer with the
basic recommendations that the user must know to make appropriate and rational use of their medications.
(annex 5 and 6).
11 PURCHASES
The establishment provides guidelines for the evaluation and selection of suppliers, through the purchasing
management procedure, guaranteeing the timely and adequate supply of the required products (see acquisition
procedures: processes and procedures manual).
Upon receipt of the purchased products, verification of each of the corresponding purchase specifications is
carried out. In the event of non-conformity with the product, it will be returned and immediately recorded in the
format provided for this purpose ( annex8). .
12 CONTROL OF MEASUREMENT AND MONITORING INSTRUMENTS
The thermometers and thermohygrometers used for the 18th edition and control of environmental conditions for
the preservation of products will be calibrated annually.
13 INFORMATION ANALYSIS AND IMPROVEMENTS
CUSTOMER SATISFACTION: with the PQRS reception and treatment procedure, the establishment monitors the
customer's perception of compliance with their requirements and takes the necessary measures when
dissatisfaction with a product or service is identified.
INTERNAL AUDITS: in order to identify effectiveness and compliance of the system with the planned provisions,
in compliance with the ISO 9001 standard, internal audits will be carried out twice a year (annex 9 and 10 ).
DATA ANALYSIS: to analyze the results of the data obtained in the processes every six months by the technical
director, to identify the conformity and proper functioning of the processes, which confirm the effectiveness of the
results.
IMPROVEMENT: based on the data analysis carried out semi-annually by the technical director, the necessary
measures will be taken to guarantee the correct functioning of all activities, resulting in better service for all our
clients (annex 11 and 12)
Likewise, a training program is implemented for our workers, in order to expand their knowledge of regulations,
pharmaceutical commercial advice and other topics of interest, which lead to offering excellent service to our
clients. (annex 13 and 14).
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14 RISK MATRIX
Risk management helps to understand and improve the MAZUERA drugstore, contributes to increasing productivity and
guaranteeing efficiency and effectiveness in organizational processes, allowing the definition of a continuous
improvement strategy, providing systemic management to the MAZUERA drugstore.
What is risk?
Risk is the possibility that some event will occur that will have an impact on the institutional or process objectives. It is
expressed in terms of probability and consequences. The most common trend is the assessment of risk as a threat, in
that sense, institutional efforts are aimed at reducing, mitigating or eliminating its occurrence, but there is also the
perception of risk as an opportunity, which implies that its management is directed to maximize the results they generate.
How is risk identified?
Risk identification is carried out by determining the causes, based on the internal and/or external factors analyzed for the
MAZUERA drugstore, which in this case have identified the following risks that are evaluated according to the risk matrix
that both in its probability as well as its impact and that can affect the achievement of the objectives, which are
determined by the process map and management indicators.
SELECTION - ACQUISITION RECEPTION STORAGE DISPENSATION

INJECTOLOGY
HOW IS IRRIGATION ANALYZED?
Risk analysis seeks to establish the probability of its occurrence and its consequences, this last aspect can guide the risk
classification, in order to obtain information to establish the level of risk and the actions to be implemented.
RISK QUALIFICATION: it is achieved through the estimation of the probability of its occurrence and the impact that the
materialization of the risk may cause. Under the probability criterion, the risk must be measured based on the following
specifications.
PROBABILITY TABLE
LEVEL DESCRIPTOR DESCRIPTION FREQUENCY

1 Queer The event may occur only in Has not been presented in the
exceptional circumstances last 5 years
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2 Unlikely The event can occur at any time At least 1 time in the last 5
years
3 Possible The event can occur at any time At least 1 time in the last 2
years
4 Likely The event will occur in most At least 1 time in the last year
circumstances
5 Almost sure The event is expected to occur in More than once a year
most circumstances
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IMPACT TABLE
LEVEL DESCRIPTOR DESCRIPTION
1 Insignificant If the event were to occur, it would have minimal consequences or
effects on the MAZUERA drugstore.
2 Minor If the event were to occur, it would have little impact or effect on the
MAZUERA drugstore.
3 Moderate If the event were to occur, it would have medium consequences or
4 Elderly If the event were to occur, it would have high consequences or effects
on the MAZUERA drugstore.
5 Catastrophic If the event were to occur, it would have disastrous consequences or

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RISK ASSESSMENT
It allows the results of the risk rating to be compared with the criteria defined to establish the degree of exposure of the
MAZUERA drugstore to it; In this way it is possible to distinguish between acceptable, tolerable, moderate, important or
unacceptable risks and set priorities for the actions required for their treatment. To facilitate the qualification and
evaluation of risks, a matrix is presented below that contemplates a qualitative analysis, to present the magnitude of the
potential consequences (impact) and the possibility of occurrence (probability). The categories related to the impact are:
negligible, minor, moderate, major and catastrophic. The categories related to probability are: rare, unlikely, impossible,
probable and almost certain.
RISKS IDENTIFIED FOR THE MAZUERA DRUGS
SELECTION ACQUISITION RECEPTION STORAGE DISPENSATION—>

INJECTOLOGY
SELECTION: occurs when low-turnover or high-cost medications are selected without taking into account
epidemiological profiles and historical consumption.
ACQUISITION: occurs when you buy from unrecognized or reliable distributors, or products are purchased without an
invoice to be able to maintain traceability.
RECEPTION: occurs when there is no adequate verification of the health record, batch number and expiration date,
likewise when the product is damaged, in poor condition or with amendments.
STORAGE: occurs when the periodic control of the expiration dates of the stored medications is not carried out, when
the periodic cleaning is not carried out and when the temperature and relative humidity control is not carried out on a
daily basis, likewise when the storage of medicines as established in the processes and procedures manual, that is, in
alphabetical order, by laboratory or by pharmaceutical group, or when it is not stored in an orderly and organized manner
on shelves and display cases or in pallets, as the case may be.
MAZUERA DRUGS

DISPENSATION: occurs when a medication is dispensed in poor condition, expired, in the wrong concentration, from the
pharmacy that is not requested, without the respective medical formula or the medication that is not requested and finally
the information about it is not given. proper use of medications.
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INJECTOLOGY: occurs when you do not have the injection certificate, the instructions established in the biosafety
manual are not followed or you do not have the appropriate and equipped area.
RISK QUALIFICATION, EVALUATION AND RESPONSE MATRIX

PROBABILITY IMPACT
INSIGNIFICANT MINOR MODERATE ELDERLY CATASTROPHIC (5)
(1) (2) (3) (4)
RARE (1) b b M TO TO
UNLIKELY (2) b b M TO AND

POSSIBLE (3) b M TO AND AND
PROBABLE (4) M TO TO AND AND
ALMOST SURE (5) TO A

■ AND AND AND
B: LOW RISK ZONE : assume the risk

M: MODERATE IRRIGATION ZONE: Reduce risk, assume risk.
A: HIGH RISK ZONE: reduce risk, avoid, share or transfer
E: EXTREME RISK AREA: reduce risk, avoid, share or transfer.
ANNEX (19)
QUALITY MANAGEMENT SYSTEM MAZUERA DRUGS and
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MAZUERA DRUGS •
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MADE BY: LADY MARIA ZAPATA QUIMBAYO DafT

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DATE OF ISSUE LAST DATE VERSION 1 Street. 175 1 54

£301 ==74 > 733=
Mo 63 41B Villa del Prauo
INITIAL: UPDATE:
PERIOD
OR OF
PROCESS IMPROVEME
POLICY FORMAT AIM INDICATOR TIME GOAL
OR EVAUD NT PLAN
EVALUATE
S DO
(number of Analysis and

Increase the
complaints implementation
satisfaction of
received number quarterly 53% of
our customers
of clients served improvement
Complaint with our
*100 as necessary
registration products and
Complaints and services
and claims
claims Number of Reduce
complaints response time
Reduce the
answered or to our
number of
resolved/number quarterly 60% customers'
complaints and
of total complaints concerns
claims
* 100
Offer friendly Identify

and cordial strategies to
Patient Promote the Number of clients
service to increase the
education and appropriate advised, number
our quarterly 28% number of
information use of of clients served
customers clients advised
record medications *100
Identify
strategies to
Number of orders
Promptly increase the
Home delivery delivered/number
dispensation attend to all quarterly 70% number of
record of orders
home orders home orders
requested *100
Number of Identify
dispensing strategies to
Minimize the
errors / number of minimize
Dispensing number of
medications quarterly 53% dispensing
errors dispensing
dispensed * 100 errors
errors
Make a list of
Provide Provide
Number of times frequent
excellent Missing coverage to
selection the medication is quarterly 53% shortages and
quality records our clients'
not available/total include them in
products requests
number of sales the inventory
*100
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reception Return Number of quarterly 53% Report to

records medications suppliers
returned/number Change of
of medications suppliers
avoid entering entered *100
into inventory
products that
do not meet
quality
requirements
Number of
records outside Check
the permitted instrument
cooling range N: calibration
MAXIMUM 8°C If it is
Temperature Ensure the
Environment recurrent,
storage and humidity stability of quarterly 52%
MAXIMUM 30°C make local
record medications
HUMIDITY adjustments
Environment: that guarantee
70%RH total stability of the
number of records medications.
*100
That our staff

has extensive
knowledge of
the
Number of
pharmaceutical
employees
products Increase
Have trained Training attending
training marketed and annual 100 % training
personnel record training / total
their frequency is
number of
regulations.
employees *100
.
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APPENDIX 2
CUSTOMER SERVICE PROCEDURE, RECEPTION AND PQRS PROCESSING
Droguería MAZUERA, documents the customer service procedure to interact with its users, know their opinions and
expectations, and thus provide better quality products and services.
AIM
The use of the customer service, reception and processing procedure of PQRS is applicable to all operations related to
the process of providing MAZUERA drugstore services.
DEFINITIONS
Client: they are those that use the output of the process, they can be internal (or other departments of the company) or
external (end client).
Purchases: acquiring or obtaining something in exchange for an established price.
Requirement: it is an expectation or need established by interested parties, it establishes the criteria that a product must
meet to be compliant.
Quality: set of properties of a product or service, characteristics or consumer demands to satisfy their needs.
DESCRIPTION
At the MAZUERA drugstore, at least two salespeople must always be present, ready for the adequate and timely
attention of our clients, who will be attended to in order of arrival. After hearing what product the client requires, it must
be established whether it is over-the-counter or with a medical formula, if so, he or she will immediately proceed to
request said formula duly authorized by a doctor.
Note: in no case will medications sold under a medical formula be dispensed without presentation of said document.
Before delivering the products to the clients, verification must be made that it is really the one required by the client or the
one prescribed by the doctor (if applicable), in terms of generic name, brand, concentration, presentation, pharmaceutical
form and verify the quality of the product dispensed in the presence of the client (expiration date, hermeticity, among
others).
SUGGESTIONS, COMPLAINTS AND CLAIMS
The MAZUERA drugstore has a suggestion box at its point of sale, and formats available for our customers to express
their opinion about the quality of our products and services (annex 3).
Every month, all the forms filled out by our clients will be compiled and recorded in the monthly complaints and claims
form, in order to provide a solution and response to each and every one of them and in turn implement the internal
improvement plans in our processes that result in minimizing the probability of a new occurrence of said event (annex 4).
MAZUERA DRUGS

MAZUERA DRUGS

INITIAL: UPDATE:
ANNEX 3
MAZUERA DRUGS
FORMAT FOR PETITIONS, COMPLAINTS AND/OR CLAIMS
DATE: ______________________________________________
NAME: ______________________________________________
PHONE: _____________________________________________
E-MAIL: _____________________________________________
WE ARE INTERESTED IN YOUR OPINION, PLEASE RATE THE FOLLOWING ASPECTS OF OUR ESTABLISHMENT
ON A SCALE OF 1 TO 4.
ASPECTS TO EVALUATE BAD (1) REGULAR (2) GOOD (3) EXCELLENT (4)
QUALITY OF THE PRODUCTS
QUALITY OF THE SERVICES

PROVIDED
PRESENTATION OF THE DRUGS
PRICE OF PRODUCTS
PUNCTUALITY IN DELIVERIES
(HOMES
IF YOU WANT TO LEAVE US ANY CONGRATULATIONS, COMPLAINTS, CLAIMS OR SUGGESTIONS, CHECK THE
CORRESPONDING BOX AND THEN DESCRIBE IT IN THE SPACE.
CONGRATULATI COMPL CLAIM SUGGESTION

ONS AINT
MAZUERA DRUGS

INITIAL: UPDATE:
ANNEX4
MONTHLY FORMAT FOR PETITIONS, COMPLAINTS AND CLAIMS
MONTH COMPLAINT CLAIM SUGGESTION TOTAL
JANUARY
FEBRUARY
MARCH
APRIL
MAY
JUNE
JULY
AUGUST
SEPTEMBER
OCTOBER
NOVEMBER
DECEMBER
TOTAL
MADE BY: LADY MARIA
MAZUERA ZAPATA QUIMBAYO
DRUGS Addressjsin/Cost

INITIAL:
UPDATE:
ANNEX 5
INFORMATION ON THE PROPER USE OF MEDICATIONS
GENERAL RECOMMENDATIONS
+ Don't self-medicate
+ Do not take medications with expired expiration dates
+ Promptly follow the recommendations given by your doctor.
It does not change the route of administration indicated on the medication
+ packaging.
DOSAGE
For pharmaceutical forms, use the measuring devices inserted in the packaging (cup, spoon or
dropper) or, failing that, a measuring instrument that allows the exact measurement of your dose.
Do not crush or break up solid medications (tablets).
4-
STORAGE
4- Store medications in a dry place, away from direct sunlight or in hot humid places, such as
refrigerators or bathrooms.
Do not store medicines within the reach of children.
Store medicines in a different place than food, insecticides, or toiletries.
Cap the medication container very well
+ Do not change the original container of the medicine
4-
RECONSTITUTION
4- It mainly refers to powders or granules (antibiotics), to which water can be added to be dosed and
administered.
Follow the instructions given by the manufacturer on the box, label or insert.
Use treated or boiled water at room temperature for constitution.
Before each dose, shake very well to ensure homogeneity of the dose.
AGAINST ADVERSE REACTIONS
-I- If you experience any adverse event (discomfort or strange symptoms), related to the use of
medications, return and report it immediately to make the report to INVIMA and the
corresponding health secretary.
MAZUERA DRUGS

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INITIAL: UPDATE:
£300 87= 783=
ANNEX 6
EDUCATION AND INFORMATION FORMAT FOR PATIENTS
MAZUERA DRUGS
REPORT OF
NAME OF ADHERENCE TO
DATE MEDICINE DOSAGE STORAGE ADVERSE RECONSTITUTION
PATIENT THERAPY
REACTIONS
MAZUERA DRUGS i in
your health!
■—
uammmzmmnomuan

MAZUERA DRUGS
MADE BY: LADY LAST

DATE OF ISSUE MARIA ZAPATA QUIMBAYO VERSION 1
DATE
INITIAL: UPDATE: ©300 87g 7830
SEPTEMBER 2018 SEPTEMBER 2018 Calle 175 No G3 41 B Villa del Prado
ANNEX 7
DATE MISSING FORMAT PRODUCT BRAND CAUSE

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DATE OF ISSUE MAZUERA DRUGS
LAST DATE VERSION 1
INITIAL: UPDATE:
SEPTEMBERMADE
2018 BY: LADY SEPTEMBER
MARIA ZAPATA
2018 QUIMBAYO
MADE BY: LADY MARIA ZAPATA QUIMBAYO ©300 87g 7830
£300 87= 783=
ANNEX 8
RETURNS FORMAT
MAZUERA DRUGS
HEALTH
DATE SUPPLIER BILL PRODUCT BATCH DUE DATE CAUSE
REGISTER
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INITIAL: UPDATE:
ANNEX 9
INTERNAL AUDIT PROCESS
The MAZUERA drugstore documents the internal audit procedure to control and verify the essential conditions for the provision of the activities and/or processes of
the pharmaceutical service if any anomaly arises that affects the presentation of an excellent quality service.
AIM
Review and perfect the operation of all the processes carried out in our MAZUERA drugstore.
SCOPE
The use of the internal audit procedure is applicable to all aspects that directly or indirectly influence the quality of our products and services.
DEFINITIONS
Audit: verification that the quality management system is being met.
DESCRIPTION
/ An evaluation of each of the items stated in the internal audit report will be carried out semi-annually by the owner of the MAZUERA drugstore, with respect
to: human talent, location aspects, area signage, notices and instruments and records. At the MAZUERA drugstore, the technical director will attend the
visit.
/ Review nonconformities and identify causes
/ Once the causes of the nonconformities have been determined, actions must be proposed to ensure that these events do not happen again.
/ The results of the actions taken must be presented in order to measure their effectiveness.
MAZUERA DRUGS

©300 87g 7830
INITIAL: UPDATE:
ANNEX 10
AUDIT FORMAT
DATE: HOUR:
NAME OF WHO ATTENDS THE AUDIT
NAME OF WHO PERFORMS THE AUDIT
HUMAN TALENT
ASPECT TO VERIFY FULFILLS FAILS DOES NOT
IT HAS A TECHNICAL DIRECTOR APPLY
PHYSICAL RESOLUTION IN THE ESTABLISHMENT
FOOD HANDLING CARD NOT LESS THAN ONE YEAR
CURRENT EMPLOYMENT CONTRACT
LOCATIONAL ASPECTS
WALLS IN GOOD CONDITION APPLY
FLOORS IN GOOD CONDITION
CEILINGS IN GOOD CONDITION
PROTECTED ELECTRICAL NETWORKS
AREA SIGNAGE
APPLY
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ADMINISTRATIVE AREA
TECHNICAL RECEPTION AREA
QUARANTINE AREA
RETURNS AREA
STORAGE AREA
DISPENSATION AREA
WASTE AREA
NOTICES
quamemmmsummmammcam
EteffiffiE ba Gamceee
• 7=
DATE OF ISSUE LAST DATE VERSION 1 £301 54 ==74 > 733=
Street. 175 1 Mo 63 41B Villa del Prauo
INITIAL: UPDATE:
MAZUERA DRUGS
SMOKE-FREE SPACE APPLY
THE SALE OF ANTISEPTIC ALCOHOL IS PROHIBITED
EVACUATION ROUTE
ENTRY TO PETS IS PROHIBITED ©300 87g 7830
MEASURING EQUIPMENT AND INSTRUMENTS

RECHARGED FIRE EXTINGUISHER (UNDER ONE YEAR OLD) APPLY
CALIBRATED FRIDGE THERMOMETER (UNDER ONE YEAR)

CALIBRATED THERMOHYGROMETER (UNDER ONE YEAR)
FRIDGE IN GOOD CONDITION
SPANISH IN GOOD CONDITION (NO RUST, OR CORROSION)
RECORDS
TECHNICAL RECEIPT RECORD APPLY
DAILY REFRIGERATION TEMPERATURE RECORD
RECORD OF ENVIRONMENTAL CONDITIONS DAILY
(TEMPERATURE AND HUMIDITY)
RETURN RECORDS
RH1 FORMAT
USER INFORMATION REGISTRATION
REGISTRATION OF ADVERSE REPORTS
REGISTRATION OF SUGGESTIONS, COMPLAINTS AND CLAIMS
MAZUERA DRUGS and
■—
ummmmmmnomua
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INITIAL: UPDATE:
MAZUERA DRUGS

©300 87g 7830
MAZUERA DRUGS FO ORQGUERIS i Peusanda in your
Health!

R : a0' 07=4 ==2
ufm@DE
uammmanmmnmmu
©300 87g 7830 Calle 175 No 63 41B

DATE OF ISSUE LAST DATE VERSION1 Villa del Prailo
INITIAL: UPDATE:
ANNEX 11
CORRECTIVE, PREVENTIVE AND CHANGE CONTROL ACTION PROCEDURES
AIM
Determine the causes of nonconformities and create actions that prevent such nonconformities from occurring
again, analyzing the results and effectiveness of the actions taken.
DEFINITIONS
Corrective action: a corrective action is the set of activities that are developed to track a nonconformity until its
cause is discovered; generate solutions to avoid its repetition, implement the changes that are necessary and
ensure that these changes are permanent and produce the desired result. A corrective action does not solve an
incident, but rather attempts to prevent it from happening again.
Preventive action: action taken to prevent (prevent) a non-conformity that could occur (but that has never
occurred until now) from happening.
Improvement action: any action that represents an improvement in the efficiency and/or efficiency of any activity
of the health management system.
Conformity: it is the fulfillment of a requirement.
SCOPE
The use of the corrective, preventive actions and change control procedure applies to all processes of the quality
management system, and other processes and procedures carried out in our establishment that interfere with the
quality of the products and services offered to our clients. .
DESCRIPTION
1. Review nonconformities and determine their causes.
All non-conformities in each process must be reviewed, as well as the results obtained from the internal audits
carried out, as well as the reporting of complaints and claims. Once the nonconformities have been identified and
quantified, each and every one of them will be analyzed, identifying their causes, and corrective actions will be
proposed to ensure that these nonconformities do not occur again.
2. Implementation of corrective actions.
The person responsible for the process where the nonconformities have been presented will be in charge of
executing the improvement actions.
3. Evaluation of actions
In the period following the taking of corrective measures, a report will be made on the effectiveness of the
implementation of the corrective actions.
MAZUERA DRUGS

INITIAL: UPDATE:
ANNEX 12
CORRECTIVE AND PREVENTIVE ACTION RECORD FORMAT

PROCESS DATE
ORIGIN AUDIT PQRS INDICATORS
TYPE OF ACTION PREVENTIVE CORRECTIVE IMPROVEMENT
IDENTIFICATION AND DESCRIPTION OF THE CAUSE OR SITUATION THAT GENERATES THE
IMPLEMENTATION
OF ACTIONS
PLAN TO EXECUTE
RESPONSIBLE FOR THE IMPLEMENTATION OF THE ACTIONS
PERIOD OF EXECUTION
OBSERVATIONS
MAZUERA DRUGS

INITIAL: UPDATE:
ANNEX 13
TRAINING PROCEDURE
AIM
Establish the training procedure at the MAZUERA drugstore, in order to keep all our staff updated on current
pharmaceutical regulations, expansion of knowledge of the products sold in our MAZUERA drugstore, marketing
techniques, explanation of the implementation of new processes and others. topics of interest that arise with the
development of our functions.
SCOPE
This procedure applies to all staff at the MAZUERA drugstore.
DESCRIPTION OF ACTIVITIES
1. STAFF INDUCTION: all personnel entering work must be included in the training and training program
for their position, which must include the following activities:
2. Socialization talks on health regulations that apply to the storage and dispensing of medications and
medical devices.
3. Knowledge of the quality manual
4. Training in the application of the manual of processes and procedures that apply to the position.
5. Knowledge of occupational health and sanitation and hygiene.
6. Knowledge of the technical characteristics of the products.
7. Knowledge of the establishment's other work rules and the functions manual.
The induction period should not be less than 1 month, in which after the theoretical part there will be
accompaniment in the practical part by the technical director. An evaluation of understanding by staff must be
carried out. Registration will be made in the training format.
2. RE-TRAINING: all staff are included in re-training campaigns in which the staff's knowledge and
adherence to the activities assigned to their position will be reviewed. This program will be adjusted
manually and recorded in the schedule.
3. TRAINING
All training activities must be recorded in the training record.
Collaborators must be trained in the aspects that concern each one in order to be able to perform their
tasks efficiently, effectively, and efficiently, which does not imply that they cannot be trained on different
topics.
A continuing training program is generated annually, which must include at least storage and
occupational health topics.
MAZUERA DRUGS
4. PROCEDURE.
1. Set theme
MAZUERA DRUGS

INITIAL: UPDATE:
2. Inform by internal communication the time, place and duration of the training to the required
personnel.
3. Fill out the attendance list.
4. Conduct research on the topic to be discussed in order to measure the level of knowledge prior to
the activity.
5. Training development.
6. Post-training exam to verify retention and clarity in the topics covered.
7. Generate a training record to record that each attendee was trained on said topic.
health!
MADE BY: LADY MARIA ZAPATA QUIMBAYO Addressjsin/Cost
ANNEX 14
TRAINING REGISTRATION FORMAT

ISSUE SPEAKER
PLACE RESPONSIBLE
START TIME END TIME
NAME PHONE SIGNATURE

EMAIL
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
MAZUERA DRUGS

INITIAL: UPDATE:
ANNEX 15
PHARMACOVIGILANCE AND TECHNOVIGILANCE PROCEDURE
AIM
Establish the procedure in case of an adverse case to a medication or medical device.
SCOPE
Our responsibility ranges from informing the patient that they must report any event (discomfort or strange
symptoms) related to the use of medications to us, to making the report to the corresponding health secretary and
INVIMA, in order to contribute to the surveillance information systems. epidemiology of the country.
As well as taking preventive and corrective measures to reduce the incidence of adverse events and eliminate risks
that may trigger an adverse event.
DEFINITIONS
Pharmacovigilance: it is the science and activities related to the detection, evaluation, understanding and
prevention of adverse events or any other problem related to medications. Pharmacovigilance is the fundamental
pillar for the country to truly determine the safety profile of the medications that are marketed, in this way they can
detect, among others: adverse reactions, inappropriate uses, therapeutic failures and complications not detected
during the research stage of the medications. Any suspicion of adverse events related to pharmaceutical products
must be reported to the competent authority.
Technovigilance: is defined as the set of post-marketing activities that aims to identify, evaluate, manage and
disseminate events, and serious and unwanted adverse events related to the use of medical devices that are
imported, manufactured, and distributed in the country. country, as well as the identification of the risk factors
associated with them, based on notification, registration and evaluation, in order to determine the frequency,
severity, and incidence of the same to prevent their appearance, and take efficient measures in order to to protect
the public health of Colombians.
Adverse event: it is an injury or damage caused to the patient by the care intervention or use of medications or
medical devices, not by the underlying pathology, which may or may not be preventable.
Serious adverse event: unintentional event that could have led to the death or serious deterioration of the health
of the patient, operator or anyone who is directly or indirectly involved, as a consequence of the use of a medication
or medical device, such as : damage to a body function or structure, leading to permanent or partial disability,
requiring hospitalization that is the origin of a genetic malformation, among others.
Non-serious adverse event: unintentional event other than those that could have led to death or serious
deterioration in the patient's health.
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©300 87g 7830

MAZUERA DRUGS
MADE Addressjsin/Cost
MADEBY:
BY:LADY
LADYMARIA
MARIAZAPATA
ZAPATAQUIMBAYO
QUIMBAYO
INITIAL: UPDATE:
REPORTING OF ADVERSE REACTIONS
Notifications of adverse events by the community are the fundamental basis of the pharmacovigilance program,
hence the importance of notifying any suspicion to INVIMA, an entity that has unified the reports in a specific format
in which the complaints and claims of clients regarding the use of medications.
PROCEDURE
1. Take the client or reporter's data: full name, ID, address and contact telephone number.
2. Take the product data: trade name, concentration, presentation, batch, date of
expiration, health registration and manufacturer.
3. Take the most detailed description of the adverse event possible.
4. Fill out the corresponding INVIMA format (FOREAM suspicion of adverse event to medication report
format) Available on the website: http//invima.gov.co/ and send it to both the
emailsegurosbogota@saludcapital.gov.co and the email invimafb@ invima.gov.co
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©300 87g 7830

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INITIAL: UPDATE:
£300 87= 783=
ANNEX 16
INVIMA ADVERSE DRUG REACTIONS REPORT FORM
1. REPORT INFORMATION
Date of notification Report origin Name of the institution where the event occurred PNF code
Department - Municipality
AAA MM D.D.
Primary report name
Profession of the primary reporter Institutional email of the primary reporter
2. INFORMATION OF THE PATIENTE

DATE OF BIRTH Patient's age at the time Patient identification document Patient sex Weight Size
PATIENT of the AE initials
Age Years/ DC YOU R.C. NUIP Code Other YEAH M F YEAH (kg) (cm)
Months/days lab
AAAA MM D.D.
Main diagnosis and other diagnoses
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£300 87= 783=
3. MEDICATION INFORMATION
Record all medications used and mark the suspect(s) with an “S”, the concomitants with a “C” and the interactions with an “l”.
S/C/I Indication Dose Unit of Route of Administration Start date Finish date
Medicine (international measurement administration Frequency
common name or generic
name)
Commercial information of the suspected drug

Health registration holder Tradename Health Register batch
4. ADVERSE EVENT INFORMATION

Onset date of the Adverse effect
adverse effect
AAAA MM D.D.
Description and analysis of the adverse effect Outcome of the event (Mark with an X)
either Recovered/resolved without
consequences
either Recovered/resolved with
consequences
either Recovering/resolving
either Not recovered/ No resolved
either Fatal
either A stranger
Seriousness (Mark with an X)
eitherproduced or prolonged hospitalization
eitherAnomaly congenic
eitherThreat of life
either___________Death (Date )
either Produced disability or disability
permanent/major medical condition
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INITIAL: UPDATE:
£300 87= 783=
YEAH NO DOES NOT

Did the event occur after administering the medication? KNOW
Are there other factors that could explain the event (medications, pathology, etc.)?
Did the event go away after tapering or stopping the medication?
Had the patient already had the same reaction to the suspected medication?
Can the patient information related to the event be expanded?
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DATE
DATEOFOF
ISSUE
ISSUE LAST
LAST DATE
DATE VERSION 1 1
VERSION
INITIAL:
INITIAL: UPDATE:
UPDATE:
SEPTEMBER
SEPTEMBER 2018
2018 SEPTEMBER2018
SEPTEMBER 2018
£300 87= 783=
INSTRUCTIONS FOR COMPLETING THE SUSPECTED EVENTS FORM

ADVERSE TO MEDICINE (FOREAM)
1. REPORTER INFORMATION
Notification date: indicate the date on which the form is completed.
Origin of the report: indicate the department and/or municipality where the adverse event occurs
Name of the institution where the event occurred: indicate the name of the institution where the adverse
event occurred.
PNF code: Indicate the PNF code assigned by the national drug and food surveillance institute INVIMA at the
time of registration to the national drug surveillance program through the link:
http:/cesos.invima.gov.co:8080/reportesfv /login/ingresofv.jsp.
Primary Reporter Name: Indicate the name of the person reporting the adverse event.
Profession of the primary reporter: indicate the profession of the primary reporter (Physician,
Pharmaceutical Chemist, Nursing Professional, other other or unknown health professional).
Institutional email: includes the institutional email of the person making the report. The objective of this
information is to have the notifier's data to request more information when required and/or to send feedback on
the report, when warranted.
2. INFORMATION OF THE PATIENTE
Date of Birth: Indicates the patient's date of birth as follows: YYYY-MM-DD
Patient Age at Adverse Event: Indicate the patient's age at the time the adverse event occurred. Specify this
age in years, months and days as appropriate.
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Patient identification document: indicate the patient's identification document taking into account: CC-
citizenship card, TI identity card, RC civil registry, NUIP unique personal identification number, laboratory
code, in the other field you can include the following identification documents (CE immigration card, passport,
minor without identification, S/I without information. The objective of this field is to identify cases of duplicates
and follow-up information of a previously notified case. For this field you can relate one of the following fields:
Patient initials: Initials must be entered in the following order: first name(s), last name(s) without signs or
spaces between them. For example: JXJX
Sex: mark with an x in the corresponding box: M (male) F (female), S/I (no information)
Weight: indicate the patient's weight in kilograms (kg)
Height: records the patient's height in centimeters (cm)
Main diagnosis and other diagnoses: in this field indicate the main diagnosis, other diagnoses and
important data such as: liver, kidney, liver failure, allergies, history, pregnancy, results of clinical and
paraclinical examinations, among others.
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INITIAL: UPDATE:
3. MEDICATION INFORMATION
MEDICATION: record all medications used according to International Common Name I (INN) or Generic
Name. Mark the suspect(s) with an “S”, the concomitant(s) with a “C”, and the interactions with a “Y”.
INDICATION: Describe the indication of the medication.
DOSE AND UNIT OF MEASUREMENT: Indicate the dose supplied in quantity and units of measurement,
according to the corresponding box (for example: 500 mg). Units of measurement include: Deciliter, drops,
gram, continuous infusion, kilogram, liter, microgram, milliequivalent, milligram, milliliter, millimoles, puff,
international units or without information.
ROUTE OF ADMINISTRATION: Describe the route of administration of the medication taking into account the
following routes of administration: Alveolar and bronchial, buccal, conjunctival, epidural, intestinal, intraarcular,
intradermal, intramedullary, intramuscular, introcular, intraperitoneal, intrauterine, intravenous, oral, otic,
epidural, pyelotophoresis, rectal and others.
ADMINISTRATION FREQUENCY: Indicate the frequency or interval of medication administration taking into
account the following frequency of administration: every hour, every 2, 3,4,5,6,8,12,24 hours,14,21,28
days,weekly , biweekly, monthly, bimonthly, quarterly, semiannual, annual and according to the scheme.
START DATE: Indicate the date on which treatment with the medication began.
ENDING DATE: Indicate the date on which treatment with the medication ended. In the case of non-
completion of treatment, indicate it with the word “continuous”.
COMMERCIAL INFORMATION OF THE SUSPECTED MEDICATION: Indicate the commercial information of

the suspected medication, which includes: name of the pharmaceutical laboratory or holder of the health
record, commercial name of the drug, health record and batch.
4. ADVERSE EVENT INFORMATION:
START DATE OF THE ADVERSE EVENT: Indicate the exact date on which the reaction began as follows:
YYYY-MM-DD.
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ADVERSE EVENT: Any unfortunate medical event that may occur during drug treatment, but does not
necessarily have a causal relationship with said treatment.
DESCRIPTION AND ANALYSIS OF THE ADVERSE EVENT: Describe in detail what the signs and
symptoms of the adverse event were. If you have test results or diagnostic examinations or medical
procedures, it must be attached to the report.
OUTCOME OF THE ADVERSE EVENT: Mark with an X, according to the box corresponding to the
corresponding outcome.
SERIOUSNESS: Mark the corresponding option(s) with one or more

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INITIAL: UPDATE:
EVENT ANALYSIS: Answer the related questions at the end of the report. If the answer to the question is
affirmative, mark “YES”, if the answer is negative, mark “NO”, if you know the information, mark “DON'T
KNOW”.
For the analysis of the adverse event, consult the Guide to determine the causality of RAMS-IVC-VIG-GU001
published on the INVIMA website at the following
link:http: //www.invima.gov.co/images/pdf/farmacovigilancia_alertas/reporte_reacciones/IVC-VIG-GU001.pdf
GENERAL RECOMMENDATIONS FOR NOTIFICATION
REPORT SUSPECTED ADVERSE EVENT(S) WITH: Medications. (Traditional and homeopathic), medicines
based on natural products (Phytotherapeutics), diagnostic or contrast media, special nutrition products
(Supplements, Children's Formulas), medicinal gases; report even if you are not sure which product caused
the event.
REPORT ALL SUSPECTED ADVERSE DRUG EVENTS: Expected or known, unexpected or unknown, mild,
non-serious and serious events or reactions. Likewise, events related to medication errors (Prescription,
dispensing, preparation, administration) and possible therapeutic failures.
ADDITIONAL INFORMATION: If you do not have enough space to record the information, use additional
sheets.
INFORMATION FOR SENDING PHYSICAL REPORTS:
Address: Carrera 10#64-28 Bogota, Colombia
Telephone: (1)2948700,ext.3916;Fax: ext.3867
Email: invimafv@invima.gov.co
Location of this format on the website: https// www.invima.gov.co/c%C3%B3moreportar-eventos- adversees-

a-medicamentos
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INFORMATION FOR REPORTING ADVERSE EVENTS THROUGH THE ONLINE FOREAM FORMAT:
To report adverse events through the available web platform, access the following link:
htt://processes.invima.gov.co:8080/reportesfv/loginUsuario.jsp
The information contained in this report is epidemiological information, therefore it is confidential and will be
used only for health purposes. The Ministry of Health and social protection and INVIMA are the only
institutions competent for its dissemination. (Law 9 of 1979).
When sending the report, be sure not to print or send the instructions that accompany this format.
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INITIAL: UPDATE:
ANNEX 17
DOCUMENTARY MANAGEMENT PROCEDURE AND RECORDS
1. AIM
Establish guidelines at DROGUERIA MAZUERA that allow the efficient, effective and effective application of
the processes of creation, updating and control of documented information.
2. SCOPE
This procedure applies to the preparation of manuals, procedures, instructions, formats and other documents
necessary in the quality management system, it begins with the information that DROGUERIA MAZUERA
requires and ends with the conservation and disposal.
3. GLOSSARY
Data: Facts about an object
Document: Information and the medium in which it is contained.
Information: Data that has meaning
Record: Document that presents results obtained or provides evidence of activities carried out.
Information system: Network of communication channels used within an organization.
Documented information: Mazuera Drugstore must control and maintain information and the medium that
contains it.
4. RESPONSIBLE
ADMINISTRATOR-TECHNICAL DIRECTOR: They are responsible for the disclosure and compliance with
this procedure.
AUXILIARIES: They are responsible for the records of the processes.

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5. GENERAL CONDITIONS
• All quality management system documents must comply with the activity requirements defined in
this procedure.
• The dissemination of new documents or those for which new versions are generated are the
responsibility of the administrator or technical director, as well as the modification or creation.
• The quality management system codes assigned according to the process map will be defined by
the company.
• For the coding of documents, the following methodology must be followed:
PART 1: Designates the process code to which the document belongs according to the process map.
PART 2: Designate the document code.

MAZUERA DRUGS
MAZUERA DRUGS i in
your health!
■—
uammmzmmnomuan
©300 87g 7830

INITIAL: UPDATE:
PART 3: Designates the consecutive number which begins at 01, controlled by process.
Between the different parts of the code there is a hyphen that separates it. Example :
Code for the characterization of the strategic planning process.
Strategic planning – Characterization – 01 PLE – CP – 01.
• The content of the documents varies depending on the type, in accordance with what is established in
the following table:
Standard/policy
Change history
development
references
definitions
conditions
Content or
Reference
document
General
Normal
object
scope
Document type
Yea
Manuals Yeah Yeah Yeah Yeah Yeah Yeah Yeah Yeah
h
Procedures Yeah Yeah No Yeah Yeah Yeah Yeah No Yeah
Yea
Protocols Yeah Yeah Yeah Yeah NA Yeah No Yeah
h
Does not
Formats No No No If apply Yeah Yeah No Yeah
apply
instructions No No No Optional No Yeah optional No Yeah
health!
Addressjsin/Cost
©300 87g 7830


INITIAL: UPDATE:
6. PROCEDURE
REGISTRATION OR
No. ACTIVITY DESCRIPTION OF THE ACTIVITY RESPONSIBLE
DOCUMENT
health!
©300 87g 7830

Determine the
Detect the need to create, modify Administrator and
1 documented information NA
and/or delete a document technical director
needed
Create or modify documents
Create or modify Administrator and
2 according to the detected need NA
documents technical director
Define the corrections and make
Define correction and Administrator and
3 any adjustments that may be NA
adjust the document technical director
necessary in the document
Approve documents whether they
are new documents or new Administrator and
4 Approve the document NA
versions of existing documents technical director
Incorporate the record of

Administrator and
5 Check in to change log modifications of changes made to Document Master List
technical director
the documents
Share the new or
Socialize the creation or Administrator and
6 modified document NA
modification of documents technical director
QUALITY MANAGEMENT SYSTEM MAZUERA
MAZUERADRUGSDRUGS
and
■—
health!
ummmmmmnomua
Addressjsin/Cost

INITIAL: UPDATE:
MADE
SEPTEMBER BY: LADY MARIA
2018 ZAPATA2018
SEPTEMBER QUIMBAYO
INITIAL: UPDATE: ANNEX 18
SUPPLIERS CONCEPT
MASTER LIST OF DOCUMENTS

PROCESS DOCUMENT TYPE DOCUMENT NAME
Strategic planning Process map Process map
Strategic planning Mission, vision and quality policy Mission
Strategic planning Characterization Process characterization
Strategic planning Procedures Risk matrix
Strategic planning Format SWOT Matrix

Strategic planning Format Risk Matrix
Evaluation and improvement Procedure Internal audit procedure
Evaluation and improvement Procedure Corrective action procedure
Evaluation and improvement Format Internal audit

Evaluation and improvement Format Corrective action
Dispensing Format Patient information and education
Post-sale surveillance Drug surveillance procedure

Drug surveillance procedure
Post-sale surveillance Format FORAM
Post-sale surveillance Procedure Requests, complaints and claims
Post-sale surveillance Procedure Customer satisfaction

Post-sale surveillance Format PQRS
Post-sale surveillance Format Customer satisfaction survey
Post-sale surveillance Format Customer satisfaction table
Human resources and talent
Characterization Process characterization
management
Procedure Organization chart and functions
management
Procedure Document management
management
Format Training schedule
management
Format Document Master List
management
health!
©300 87g 7830

health!
INITIAL: UPDATE:
£300 87= 783=
ANNEX 19
MAZUERA DRUGS RISK CONTROL TABLE
RISK ASSESSMENT ANALYSIS RISK ASSESSMENT ACTION PLAN
IRRIGATION
CONSEQUENCE PROBABILITY
EVALUATION
EXISTING DATE OF
RISK CAUSES CONSEQUENCES RISK ASSESSMENT ACTIONS RESPONSIBLE
CONTROLS IMPLEMENTATION
DESCRIPTION WORTH DESCRIPTION WORTH DESCRIPTION
health!

INITIAL: UPDATE:
MAZUERA DRUGS
FORMAT FOR PETITIONS, COMPLAINTS AND/OR CLAIMS
DATE: ______________________________________________
NAME: ______________________________________________
PHONE: _____________________________________________
E-MAIL: _____________________________________________
WE ARE INTERESTED IN YOUR OPINION, PLEASE RATE THE FOLLOWING ASPECTS OF OUR ESTABLISHMENT ON A SCALE OF 1 TO 4.
ASPECTS TO EVALUATE BAD (1) REGULAR (2) GOOD (3) EXCELLENT (4)
QUALITY OF THE PRODUCTS
QUALITY OF THE SERVICES

PROVIDED
PRESENTATION OF THE DRUGS
PRICE OF PRODUCTS
PUNCTUALITY IN DELIVERIES
(HOMES
IF YOU WANT TO LEAVE US ANY CONGRATULATIONS, COMPLAINTS, CLAIMS OR SUGGESTIONS, CHECK THE CORRESPONDING BOX AND THEN
DESCRIBE IT IN THE SPACE.
health!
MAZUERA DRUGS and

■—
ummmmmmnomua

INITIAL: UPDATE:
INFORMATION ON THE PROPER USE OF MEDICATIONS
GENERAL RECOMMENDATIONS
+ Do not self-medicate
4- Do not take medications with expired expiration dates
5- Promptly follow the recommendations given by your doctor.
6- It does not change the route of administration indicated on the medication packaging.
MAZUERA DRUGS and
■—
ummmmmmnomua
DATE OF ISSUE MAZUERA DRUGS
LAST DATE VERSION 1 I'm sorry for your
INITIAL: UPDATE: health!
DOSAGE
7- For pharmaceutical forms, use the measuring devices inserted in the packaging (cup, spoon or dropper) or, failing that, a measuring instrument that allows the
exact measurement of your dose.
8- Do not crush or break up solid medications (tablets).
STORAGE
9- Store medications in a dry place, away from direct sunlight or in hot humid places, such as refrigerators or bathrooms.
10- Do not store medicines within the reach of children.
11- Store medicines in a separate place from food, insecticides, or health products.
cleanliness.
12- Cap the medication container very well
13- Do not change the original container of the medicine
RECONSTITUTION
4- It mainly refers to powders or granules (antibiotics), to which water can be added to be dosed and administered.
4- Follow the instructions given by the manufacturer on the box, label or insert.
4 Use treated or boiled water at room temperature for constitution.
4 Before each dose, shake very well to ensure homogeneity of the dose.
REPORTING ADVERSE REACTIONS
4- If you experience any adverse event (discomfort or strange symptoms), related to the use of medications, return and report it immediately to make the report to
INVIMA and the corresponding health secretary.
health!
health!
MAZUERA DRUGS
MADEBY:
MADE BY:LADY
LADYMARIA
MARIAZAPATA
ZAPATAQUIMBAYO
QUIMBAYO
RISK CONTROL AND MONITORING TABLE
MAZUERA DRUGS
RISK ASSESSMENT ANALYSIS RISK ASSESSMENT ACTION PLAN
IRRIGATION
CONSEQUENCE PROBABILITY
EVALUATION
EXISTING DATE OF
RISK ASSESSMENT ACTIONS RESPONSIBLE
CONTROLS IMPLEMENTATION
ESCRIPTION WORTH DESCRIPTION WORTH DESCRIPTION
MAZUERA DRUGS
MAZUERA DRUGS i in
your health!
■—
uammmzmmnomuan

INITIAL: UPDATE:
EVALUATED FORMAT AIM INDICATOR GOAL RESULT

PROCESS
Complaints and Register of Increase the (number of complaints 53%
claims complaints and satisfaction of our received number of
claims customers with our clients served *100
products and
services
Reduce the number 60%

Number of complaints
of complaints and
answered or
claims
resolved/number of total
complaints * 100
dispensing Promote the proper 28%
Patient education use of medications Number of clients
and information advised, number of
record clients served *100
Home delivery 70%
record Number of orders
Promptly attend to all
delivered/number of
home orders
orders requested *100
Dispensing errors Minimize the number 53%
of dispensing errors Number of dispensing
errors / number of
medications dispensed *
100
selection Missing Provide coverage to 53%
Number of times the
records our clients' requests
medication is not
available/total number of
sales *100
Returns
reception 53%
Registration
avoid entering into Number of medications

inventory products returned/number of
that do not meet medications entered
quality requirements *100
storage Temperature and Ensure drug stability 52%
humidity record Number of records
outside the permitted
cooling range N:
MAXIMUM 8°C Ambient
MAXIMUM 30°C
Ambient HUMIDITY:
70%RH
MAZUERA DRUGS
MADE BY: LADY MARIA
DATE OF ISSUE ZAPATA QUIMBAYO
LAST DATE VERSION 1
INITIAL: UPDATE: ©300 87g 7830
SEPTEMBER 2018 SEPTEMBER 2018 Calle 175 No G3 41 B Villa del Prado
total number of records

*100
training Training record That our staff has Number of employees 100%
extensive knowledge attending training / total
of the number of employees
pharmaceutical *100
products marketed
and their regulations.

Bogota Drugstore Quality Management System

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QUALITY MANAGEMENT SYSTEM MAZUERA DRUGS and

Peusanda in your Health!

MADE BY: LADY MARIA ZAPATA QUIMBAYO

MADE BY: LADY MARIA ZAPATA QUIMBAYO

MADE BY: LADY MARIA ZAPATA QUIMBAYO

MADE BY: LADY MARIA ZAPATA QUIMBAYO

DATE OF ISSUE LAST DATE VERSION 1

1 DESCRIPTION OF THE ESTABLISHMENT

1.2 HISTORICAL REVIEW

MADE BY: LADY MARIA ZAPATA QUIMBAYO

DATE OF ISSUE LAST DATE VERSION 1

1.5 PRINCIPLES AND VALUES

1.6 WORK ENVIRONMENT

2 OBJECTIVES AND SCOPE

MADE BY: LADY MARIA ZAPATA QUIMBAYO

DATE OF ISSUE LAST DATE VERSION 1

3 DESIGN AND DEVELOPMENT

4 GENERAL REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM

MADE BY: LADY MARIA ZAPATA QUIMBAYO

MADE BY: LADY MARIA ZAPATA QUIMBAYO

DATE OF ISSUE LAST DATE VERSION 1

QUALITY MANAGEMENT SYSTEM ■—

MADE BY: LADY MARIA ZAPATA QUIMBAYO

DATE OF ISSUE LAST DATE VERSION 1

7 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

7.1 INTERNAL STRUCTURE

The MAZUERA drugstore is organized as follows.

MADE BY: LADY MARIA ZAPATA QUIMBAYO

MADE BY: LADY MARIA ZAPATA QUIMBAYO

SEPTEMBER 2018 SEPTEMBER 2018

8 STRATEGIC QUALITY FRAMEWORK QUALITY POLICIES

MADE BY: LADY MARIA ZAPATA QUIMBAYO

SEPTEMBER 2018 SEPTEMBER 2018

MAZUERA DRUGS and

The QMS documentation will be organized as follows:

MADE BY: LADY MARIA ZAPATA QUIMBAYO

MADE BY: LADY MARIA ZAPATA QUIMBAYO

The processes carried out in the establishment that

PRO dec the

8.4.2 PHVA CYCLE

-Demand V Analysis and decision

MADE BY: LADY MARIA ZAPATA QUIMBAYO

SEPTEMBER 2018 SEPTEMBER 2018

MADE BY: LADY MARIA ZAPATA QUIMBAYO

SEPTEMBER 2018 SEPTEMBER 2018

8.4.3 PROCESS MAP

MAINTENAN RESOURC MANAGEM

MADE BY: LADY MARIA ZAPATA QUIMBAYO

©300 87g 7830 Calle 175 No 63 41B

10.1 COMMUNICATION WITH THE CUSTOMER

The following communication methods have been implemented:

10.2 PROMOTION AND PREVENTION CAMPAIGNS

12 CONTROL OF MEASUREMENT AND MONITORING INSTRUMENTS

13 INFORMATION ANALYSIS AND IMPROVEMENTS

MADE BY: LADY MARIA ZAPATA QUIMBAYO

DATE OF ISSUE LAST DATE VERSION 1

How is risk identified?

SELECTION - ACQUISITION RECEPTION STORAGE DISPENSATION

HOW IS IRRIGATION ANALYZED?

LEVEL DESCRIPTOR DESCRIPTION FREQUENCY

MADE BY: LADY MARIA ZAPATA QUIMBAYO

MADE BY: LADY MARIA ZAPATA QUIMBAYO

DATE OF ISSUE LAST DATE VERSION 1