PERSONNEL

PIC/S Part I Chapter 2

PE 009-14

MARIA LOLITA B. ABO-OL, BSIP, MBA

Food-Drug Regulation Officer III
Regional Field Office-National Capital Region
 PERSONNEL
Objectives:
▪ To review general issues related to personnel
▪ To review requirements for key personnel
▪ To review the training of personnel
▪ To consider some specific issues
 PRESENTATION OUTLINE

I. Principle
II. General Guidelines
III. Key Personnel
IV. Training
V. Personnel Hygiene
VI. Consultants
 PERSONNEL
I. PRINCIPLE

The correct manufacture of medicinal products relies upon

people
 PERSONNEL

There must be sufficient qualified personnel to carry out

all the tasks which are the responsibility of the
manufacturer
Notes: Production personnel should be separate from QC
personnel
Individual responsibilities should be clearly understood
by the individuals and recorded
Notes: Job Description / Duties and Responsibilities of key
personnel should be properly signed, dated and approved.
 PERSONNEL
PRINCIPLE
All personnel should be aware of the principles of Good
Manufacturing Practice that affect them and receive initial and
continuing training, including hygiene instructions, relevant to
their needs

Notes: Regular and contractual persons must be trained on GMP, and

hygiene instructions
Training Plan for the year
Training Certificates
Trainings Conducted and Assessment
 GENERAL GUIDELINES:
1. The manufacturer should have an adequate number
of personnel with the necessary qualifications and
practical experience.
Notes:
Sufficient number of staff must be available to carry out the
work for which the manufacturer is responsible. These
people must have the level of training and experience that
will enable them to do their work.
- implementation for gaps in procedure and record keeping, lapses in
schedules, delays in CAPA and frequent defects in procedures.
 GENERAL GUIDELINES
2.1 Senior management should determine and provide
adequate and appropriate resources to implement and
maintain the Pharmaceutical Quality System and
continually improve its effectiveness.

The responsibilities placed on any one individual should

not be so extensive as to present any risk to quality

Notes: That is why the organizational chart and job descriptions are created.
The review of performance of the department is assessed through
management review.
Sample Organizational Chart
 GENERAL GUIDELINES:
2.2 The manufacturer must have an organizational chart
in which the relationships between the heads of
Production,
Quality Control and where applicable
Head of Quality Assurance or Quality Unit and the
position of the
Authorized Person(s) are clearly shown in the managerial
hierarchy.
 GENERAL GUIDELINES:
2.3. People in responsible positions should have specific
duties recorded in written job descriptions and adequate
authority to carry out their responsibilities.
Their duties may be delegated to designated deputies of
a satisfactory qualification level.
There should be no gaps or unexplained overlaps in the
responsibilities of those personnel concerned with the
application of Good Manufacturing Practice.
 Explanation
Explanation for 2.3.
Job description should describe the following: Duties, Authority, Reporting flow
The head may delegate the duties to their subordinates however the responsibility still lies
with the superior.
Overlaps can be checked if there are conflict of interest on any function
Examples of overlaps:
Owner overturns QC rejected batch
QC Head reviews the COA but releases the product
QC analyst test the product and approves the COA
Gaps are determined in assigning personnel for any task.
Examples of Gaps:
No designated personnel to carry out checks
No designated personnel to carry out data evaluation
Unclear responsibility in doing PQR for trader and manufacturer
 GENERAL GUIDELINES:
2.4. Senior management has the ultimate responsibility
to ensure an effective Pharmaceutical Quality System is
in place to achieve the quality objectives, and, that roles,
responsibilities, and authorities are defined,
communicated and implemented throughout the
organization.
 GENERAL GUIDELINES:
2.4 Senior management should establish a quality policy
that describes the overall intentions and direction of the
company related to quality and should ensure continuing
suitability and effectiveness of the Pharmaceutical
Quality System and GMP compliance through
participation in management review.
 GENERAL GUIDELINES:
III. Key Personnel

2.5 Senior Management should appoint Key Management

Personnel including the head of Production, the head of Quality
Control, and if at least one of these persons is not responsible for
the release of products the Authorized Person(s) designated for
the purpose. Normally, key posts should be occupied by full-time
personnel.
 III. Key Personnel:
The heads of Production and Quality Control must be
independent from each other. In large organizations, it may be
necessary to delegate some of the functions listed in 2.7, 2.8 and
2.9. Additionally, depending on the size and organizational
structure of the company, a separate Head of Quality Assurance
or Head of the Quality Unit may be appointed. Where such a
function exists usually some of the responsibilities described in
2.7, 2.8 and 2.9 are shared with the Head of Quality Control and
Head of Production and senior management should therefore
take care that roles, responsibilities, and authorities are defined.
 III. Key Personnel:
2.6 The duties of the Authorized Person(s) are described in the national
requirements and can be summarized as follows:
a) An Authorized Person must ensure that each batch of medicinal
products has been manufactured and checked in compliance with the
laws in force in that country and in accordance with the requirements of
the Marketing Authorization;

Notes: There should be adequate training on production and quality

control and quality assurance, review of batches, and regulations for the
Authorized person. Check the training records.
 III. Key Personnel:
2.6 The duties of the Authorized Person(s) are described in the national
requirements and can be summarized as follows:
b) The Authorized Person(s) must meet the qualification
requirements laid down in the national legislation, they shall be
permanently and continuously at the disposal of the holder of
the Manufacturing Authorization to carry out their
responsibilities;

Notes: At present, there were no local regulations on the Authorized

Person for Release of products. FDA will just stick on PIC/S GMP
provisions
 III. Key Personnel:

2.6 The duties of the Authorized Person(s) are described

in the national requirements and can be summarized as
follows:
c) The responsibilities of an Authorized Person may
be delegated, but only to other Authorized
Person(s).
 III. Key Personnel:
2.7 The head of Production generally has the following
responsibilities:
(i) To ensure that products are produced and stored
according to the appropriate documentation in order to obtain
the required quality;
(ii) To approve the instructions relating to production
operations and to ensure their strict implementation;
(iii) To ensure that the production records are evaluated and
signed by an authorized person;
 III. Key Personnel:
2.7 The head of Production generally has the following
responsibilities:
(iv) To ensure the qualification and maintenance of his
department, premises and equipment;
(v) To ensure that the appropriate validations are done;
(vi) To ensure that the required initial and continuing training
of his department personnel is carried out and adapted
according to need.
 III. Key Personnel:
2.8 The head of Quality Control generally has the
following responsibilities:

(i) To approve or reject, as he/she sees fit, starting materials,

packaging materials, intermediate, bulk and finished products;
(ii) To ensure that all necessary testing is carried out and the
associated records evaluated;
(iii) To approve specifications, sampling instructions, test
methods and other Quality Control procedures;
(iv) To approve and monitor any contract analysts;
 III. Key Personnel:
2.8 The head of Quality Control generally has the
following responsibilities:

(v) To ensure the qualification and maintenance of his/her

department, premises and equipment;
(vi) To ensure that the appropriate validations are done;
(vii) To ensure that the required initial and continuing training
of his department personnel is carried out and adapted
according to need.
Other duties of Quality Control are summarized in Chapter 6.
 III. Key Personnel:
2.9 The heads of Production, Quality Control and where
relevant, Head of Quality Assurance or Head of Quality Unit,
generally have some shared, or jointly exercised, responsibilities
relating to quality including in particular the design, effective
implementation, monitoring and maintenance of the
Pharmaceutical Quality System. These may include, subject to any
national regulations:

(i) The authorization of written procedures and other

documents, including amendments;
 III. Key Personnel:
2.9 … These may include, subject to any national
regulations:

(ii) The monitoring and control of the manufacturing

environment;
(iii) Plant hygiene;
(iv) Process validation;
(v) Training;
 III. Key Personnel:
2.9 These may include, subject to any national regulations:

(vi) The approval and monitoring of suppliers of materials;

(vii) The approval and monitoring of contract manufacturers
and providers of other GMP related outsourced activities;
(viii) The designation and monitoring of storage conditions
for materials and products;
(ix) The retention of records;
(x) The monitoring of compliance with the requirements of
Good Manufacturing Practice;
 III. Key Personnel:
2.9 … These may include, subject to any national
regulations:

(xi) The inspection, investigation, and taking of samples, in

order to monitor factors which may affect product quality;
(xii) Participation in management reviews of process
performance, product quality and of the Pharmaceutical
Quality System and advocating continual improvement;
(xiii) Ensuring that a timely and effective communication and
escalation process exists to raise quality issues to the
appropriate levels of management.
 IV. Training
2.10 The manufacturer should provide training for all the personnel
whose duties take them into production and storage areas or into
control laboratories (including the technical, maintenance and
cleaning personnel), and for other personnel whose activities could
affect the quality of the product.

Notes: All personnel (regular and contractual) that affects product

quality should be trained.

Training for functions

Training on equipment maintenance and cleaning
Training on QA
 IV. Training
2.11 Besides the basic training on the theory and practice
of the Pharmaceutical Quality System and Good
Manufacturing Practice, newly recruited personnel
should receive training appropriate to the duties
assigned to them.

SOP and WI trainings

 IV. Training
2.11 …Continuing training should also be given, and its
practical effectiveness should be periodically assessed.

Notes: How can effectiveness be assessed?

Some Examples:
Review of output (check the reject rate of operator after training)
Direct Observation of trained procedure
Parallel Testing for analysts
 IV. Training
2.11. …Training programs should be available, approved
by either the head of Production or the head of Quality
Control, as appropriate.
IV. Training

2.11 … Training records

should be kept.
 IV. Training
2.12 Personnel working in areas where contamination is a
hazard, e.g. clean areas or areas where highly active, toxic,
infectious or sensitizing materials are handled, should be
given specific training.

Notes:
Some trainings:
Training on spills management
Training on MSDS and PPE
Training on Decontamination
Training on First Aid on exposure of chemicals
 Training
2.13 Visitors or untrained personnel should,
preferably, not be taken into the production and
quality control areas. If this is unavoidable, they should
be given information in advance, particularly about
personal hygiene and the prescribed protective clothing.
They should be closely supervised.
 Training
Notes on 2.13: Visitor Management
Visitor management is also essential. The company should not pose harm to the
product caused by the visitors and likewise, the company should not harm the
visitors. For visitors there can be no exceptions to the rule of the wearing of
appropriate clothing to protect the product.
This can be done by:
Training of the visitors on the risks of materials handled,
Training on personnel hygiene requirements
Training on Gowning or Personnel Protective Equipment (PPE) requirements
Waivers on the visitors when they visit antibiotic facilities, steroid/ hormone facilities
or cytotoxic facilities is required.
 Notes:
Notes on 2.13: Visitor Management
Visitors should be supervised by in-house personnel because visitors may
contaminate the products or they may have a reaction when they are
exposed in the products. Access for visitor(s) should be limited so as not
to affect product quality.
For visitors there can be no exceptions to the rule of the wearing of
appropriate clothing to protect the product.
A word at this stage about visits by the owners of the business. This may
be a difficult area because owners may feel that if the company is theirs
they may do what they want, when they want. Somehow they have to
understand that their investment is at risk if they do not behave as
necessary.
 IV. Training
2.14 The Pharmaceutical Quality System and all the measures
capable of improving its understanding and implementation
should be fully discussed during the training sessions.

Notes: Personnel need to be trained on the Quality Policy,

Quality Objective, quality metrics (KPI for quality),
handling of deviations, change control, CAPA, Quality risk
Management, Product quality review, Management
review.
 V. Personnel Hygiene:
2.15 Detailed hygiene programmes should be established and
adapted to the different needs within the factory. They should
include procedures relating to the health, hygiene practices and
clothing of personnel. These procedures should be understood and
followed in a very strict way by every person whose duties take
him into the production and control areas. Hygiene programmes
should be promoted by management and widely discussed during
training sessions.
 Notes:
Notes on 2.15: Hygiene programmes should be developed and
customized based on the operations and needs of the company.
The program should include procedures relating to the health,
hygiene practices and clothing of personnel.

The risk of microbial contamination due to improper hygiene needs

to be cascaded at all levels of the company.
Every person in production and control requires strict compliance to
the hygiene program.

Since people is the number one cause of contamination, this should

be promoted by the management and should be discussed in training
sessions.
 V. Personnel Hygiene:
2.16 All personnel should receive medical examination upon
recruitment. It must be the manufacturer’s responsibility that there
are instructions ensuring that health conditions that can be of
relevance to the quality of products come to the manufacturer’s
knowledge. After the first medical examination, examinations
should be carried out when necessary for the work and personal
health.

Notes: Medical examination is required prior to employment and

every year. Procedure should be in place when reporting illness and
reporting back to work after an illness.
People doing inspection and testing need to be checked for color
blindness and eye examination.
 V. Personnel Hygiene:
2.17 Steps should be taken to ensure as far as is
practicable that no person affected by an infectious
disease or having open lesions on the exposed surface of
the body is engaged in the manufacture of medicinal
products.

SOP of Reporting due to sickness.

 V. Personnel Hygiene:
2.18 Every person entering the manufacturing areas should wear
protective garments appropriate to the operations to be carried
out.
Notes: Correct gowning procedures are also of paramount importance. One of the
problems with particulate contamination is that it is largely invisible to the naked
eye. Any contamination introduced into the cleanroom on the outer surface of
clothing will go unnoticed and so any breakdown in correct gowning procedures will
not be immediately apparent. Thus it is vital that operators are qualified in correct
gowning procedures. It can be very helpful if a system of mutual help is in place. That
is, the operators observe each other and, in a non-threatening way point out faults
that may occur.
V. Personnel Hygiene:

Gowning Video
 V. Personnel Hygiene:

Entry Level Gowning

 V. Personnel Hygiene:
2.19 Eating, drinking, chewing or smoking, or the storage of food,
drink, smoking materials or personal medication in the production
and storage areas should be prohibited. In general, any unhygienic
practice within the manufacturing areas or in any other area where
the product might be adversely affected should be forbidden.
Notes: No outdoor clothing, materials, food, drinks should be brought
into production and storage rooms. Cleanroom behaviour is also
important. Some examples of unhygienic practice include:
Running inside the clean area.
Blocking the patch of clean air the product
Excessive talking/ movement inside production area
Unnecessary removal of gloves
 V. Personnel Hygiene:

Cleanroom behavior
 V. Personnel Hygiene:
2.20 Direct contact should be avoided between the
operator’s hands and the exposed product as well as with
any part of the equipment that comes into contact with the
products.

Notes: Personnel are required to wear gloves especially when

the product or material is exposed to the environment. Gloves
should be checked from time to time for tears.
Personnel should disinfect their gloves frequently (every
operation but more frequent for sterile manufacture) during
operations to prevent possible introduction of contaminants
(micro) into the areas where they work or touch.
 V. Personnel Hygiene:
2.21 Personnel should be instructed to use the hand-washing
facilities.

Notes: Good personal hygiene is a requirement of all pharmaceutical

activities, from operating on the line through laboratory good
manufacturing practice (GMP) studies.
Jewelry can interfere with adequate cleansing and should be removed
before washing. Jewelry should be discouraged in areas where hand
cleanliness is important.
 V. Personnel Hygiene:
2.21 Personnel should be instructed to use the hand-washing
facilities.

Notes: Good personal hygiene is a requirement of all pharmaceutical

activities, from operating on the line through laboratory good
manufacturing practice (GMP) studies.
Jewelry can interfere with adequate cleansing and should be removed
before washing Jewelry should be discouraged in areas where hand
cleanliness is important.
Please click on the video.
 V. Personnel Hygiene:
2.22 Any specific requirements for the manufacture of
special groups of products, for example sterile
preparations, are covered in the annexes.
 VI. Consultants

2.23 Consultants should have adequate education, training, and

experience, or any combination thereof, to advise on the subject for which
they are retained.

Records should be maintained stating the name, address, qualifications, and

type of service provided by these consultants.
VII. Possible Issues
Limited number of staff
Inadequate qualifications
Inadequate experience
Owner interferes in quality decisions
Lack of means to develop training materials
 VII. Possible Issues

Company procedures take precedence over local

legislation
Unclear organization diagram
Staff movement
Inadequate training records
Illness
 References
PIC/S GMP 2017 009-013
WHO Basic GMP Training on Personnel
Gowning Reference
Handwashing, Hygiene, cGMP and Science
END

THANK YOU!

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