PHARMACEUTICAL

DOCUMENTATION

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 The 10 golden rules of GMP

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 INTRODUCTION
Documentation is the cornerstone of any company’s quality management
system and is an essential GMP requirement.

It is critical that anyone dealing with GMP documents and documentation
systems understand the regulatory requirements and adopts best practice.

It defines a system of information and control so that risks inherent

in misinterpretation and/or error in oral communication are minimized.

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 NEED OF DOCUMENTATION

Mandatory as per regulatory

guidelines

Keep track of activities

Evidence to face legal

issues

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 OBJECTIVES OF DOCUMENTS
To define the specifications and procedures for all materials and method of
manufacture and control.
To ensure that all personal concern with manufacture know what to do
and when to do it.
To ensure that authorized persons have all the information necessary to
decide whether or not to realize a batch of a drug for sale.
To ensure the existence of documented evidence, trace ability, and
to provide records and an audit trail that will permit investigation.
 It ensures the availability of the data needed for validation, review
and
statistical analysis.
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 SCOPE
Good documentation encompasses practically all the aspect
of pharmaceutical production :
 Building and premises: installation, validation , cleaning and maintenance
 Personnel : Training, hygiene etc
 Equipment : installation , calibration , validation , maintenance , cleaning
 Materials: specification, testing, ware-housing, use, rejection/disposal.
Processing: individual steps in the process of manufacturing
including controls thereof.
 Finished goods: specifications, testing, storage, distribution,
and
rejection/disposal.
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 DOCUMENTATION LIFECYCLE

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 TIERS OF DOCUMENTATION(ISO 9001:2008)

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 Types of documents
Quality
manual

Logbooks Policie
s

Standard
operating
Specifications
procedures
(SOPs)

Test methods Batch

records

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 CHARACTERISTIC OF DOCUMENT
For effective use of documents, they should be designed and prepared with
utmost care. Each document shall:
(i) Have a clear title.
(ii) Have an identification number.
(iii) Be approved by authorized person.
(iv) Have the date of issue
(v) Have a due date of revision.
(vi) List to whom it has been issued.

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 “Where the documents carry instructions”
(i) The instructions shall be precise.

(ii) They shall be for each individual step and not combined.

E.g. Weigh the materials; charge the weighed materials into the

blend

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 “Where entry of any data is expected”
(i) Sufficient space shall be provided for making the entry.
(ii) Heading shall clearly indicate what is to be entered, and who is responsible.
(iii) All entries shall be in ink.
(iv) All entries shall be clear and legible.
(v) Person making the entries shall confirm the entry by initialing/signing the
same.
(vi)An error in entry shall be so corrected that the original (wrong) entry is not
lost. Such correction shall also be initialed and dated. Where necessary, reason
for correction shall also be recorded, initialed and dated
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 DOCUMENTATION REVIEW
Documentation system should provide for a periodic review, and revision,
if necessary, of any document, or part thereof.

 Such revised versions shall also be approved by the authorized persons.

 Updated/revised versions shall also be superseding the previous

edition,
and the document shall clearly indicate this.

Outdate/superseded document shall be immediately removed from active

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use, and copy retained only for reference.

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 ELECTRONIC DATA
If documentation is through electronic data processing
system (computerized system) there shall be adequate, reliable systems in
place:

1.To check and ensure correctness of data.

2.To record changes (addition/deletion)

3. That meets other regulation requirement, if any

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 “DOCUMENTS” MODEL
D= Design, development, deviations, dossiers and Drug Master Files for regulated markets, distribution
records
O= Operational procedures/techniques/methods, Out of specifications (OOS), Out of trend (OOT)
C= Cleaning, calibration, controls, complaints, containers and closures, contamination and change control
U= User requirement specifications, utilities like water systems, HVAC, AHU etc.
M= Man, materials, machines, methods, maintenance, manufacturing operations and controls, monitoring,
master formula, manuals (quality, safety and environment), medical records
E= Engineering control and practices, Environment control, Equipment qualification documents
N= Non-routine activities, New products and substances
T = Technology transfer, training, testing, Trend analysis, Technical dossiers
S= SOPs, safety practices, sanitation, storage, self-inspection, supplier qualification,
standardization, specifications and standard test procedures and site master file

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 STANDARD OPERATING PROCEDURES (SOP’S)
 A typical Pharmaceutical Industry has an average of 1200- 1300
 SOPs.
A Parenteral Drug Association (PDA) survey found that a
pharmaceutical
typical company must manage an average of 1250 SOPs.
A Standard Operating Procedure (SOP) is a set of written instructions that
document a routine or repetitive activity which is followed by employees in
an organization.
The development and use of SOPs are an integral part of a successful
quality system.
It provides information to perform a job properly, and consistently in order
to achieve pre-determined specification and quality end-result.

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 BENEFITS OF SOP
To provide people with all the safety, health, environmental and operational information
necessary to perform a job properly.
To ensure that production operations are performed consistently to maintain quality control of
processes and products.
To ensure that processes continue uninterrupted and are completed on a prescribed schedule.
To ensure that no failures occur in manufacturing and other processes that would harm anyone in
the surrounding community
To ensure that approved procedures are followed in compliance with company and government
regulations.
To serve as a training document for teaching users about the process for which the SOP was
written
To serve as a checklist for co-workers who observe job performance to reinforce proper
performance.
To serve as a checklist for auditors.
To serve as an historical record of the how, why and when of steps in an existing process so there
is a factual basis for revising those steps when a process or equipment are changed.
17
 SOP PROCESS

Frequency of
Review Revisions
Preparation
and and Reviews
Approval

Document
Checklists Document Tracking
Control and
Archival

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 “How to write?”
OBJECTIVE:
To lay down procedure for the preparation of Standard Operating
Procedures. SCOPE:
This procedure is applicable to all the SOP’s throughout the
organization. RESPONSIBILITY:
Person Performing: Respective HOD’s of concerning departments
Person Monitoring: QA officer/ HOD
QA PROCEDURE:
All SOP’s shall be computer typed
using Times New Roman font.

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 “How to write?”
Format of SOP shall be as per Annexure SOP/QA/002/1. Each SOP has:

I) Header,

II) Signature block and

III) Body

Header: Present on all the pages of SOP and includes

Company Logo, Name, address & Concerned Dept.: Company Logo, CHARAK
Pharma Limited, Wagholi-Pune & Name of Concerned Department.

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 “How to write?”
Document Type: Standard Operating Procedure (In capital bold letters of font size
14) Ref. No.: It is like SOP/DC/YYY-Z Where DC depicts the department code as
below:
Abbreviation-

PE: Personnel Department PD: Production

Department MT: Maintenance Department QA: Quality Assurance
Department QC: Quality Control Department ST: Store Department
PU: Purchase Department
YYY is the sequential number starting from 001 for each
department.
And Z is the revision status, starting
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from 0 for the original version and 1 for the next
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 “How to write?”
Supersedes: It is the Ref. No. of the earlier version. (In capital letters of font size 12).

Effective Date: It is the date from which the SOP shall be put in use. The date format has
to be DD/MM/YYYY, where DD indicates the date, MM indicates the month & YYYY
indicates the year (e.g. 01/11/2007). Date shall be written with blue indelible ink pen.

Review Date: It is the Month & Year during which the SOP shall be revised e.g.
21/2013, written with blue indelible ink pen. It shall be maximum 2 years from the
effective date.

Page No.: It is like X OF Y. Where X is the individual page number and Y is the total
number of
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 “How to write?”
Title: It shall be clear and descriptive. (In bold capital letters of font size 12).
Signature Block: It shall be below the header and only on the first page of the SOP.
(Titles in the rows & columns shall be in bold letters & other text in normal letters of font
size
12. Name and designation shall be typed. And signature and date shall be put in blue
indelible ink pen)
Prepared by: Signature with date, name and designation of the person from user
department
who has drafted the SOP.
Verified by: Signature with date, name and designation of the HOD or the person from
user department who has verified the draft of the SOP.
Authorized by: Signature with date, name and designation of the person authorizing
SOP , DGM QA or HOD QA.
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 “How to write?”
Body: It shall contain the subject matter, which is written in the following Manner.

(Subtitles in capital bold letters and text matter in normal letters of font size 12).

OBJECTIVE: It shall define the purpose of the

SOP. SCOPE: It shall define the area of

application.

RESPONSIBILITY: It shall specify the person responsible for carrying out and monitoring the
activity as per the SOP.

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 “How to write?”
PROCEDURE: It shall give all steps required by the process in a proper sequence and
instructions to be followed while carrying out the activity so as to achieve the desired
goals.
Procedure shall be:
a) Logically lay out.
b) Written in the imperative (authoritative) tense.
c) User friendly.
d) Simple to understand and in plain unambiguous English.
e) To the point with no unnecessary information.
f) In standardized terminology.

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 “How to write?”
ABBREVIATION: This shall include list of abbreviations used and their
meaning.
ANNEXURE: This shall include list of annexure attached.
REFERENCE: This shall include list of reference
documents. ABBREVIATION:
HOD : Head of the Department SOP : Standard Operating
Procedure. QA : Quality Assurance DGM : Deputy General Manager
ANNEXURE:
Annexure – SOP/QA/002/1 - ‘Standard Operating Procedure’
Form. REFERENCE:
SOP issuance logbook
Standard SOP format.

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 MASTER FORMULA RECORD
Master formula record (MFR) is a master document for any pharmaceutical
product.

 It contains all information about the manufacturing process for the

product.

MFR is prepared by the research and development team of the company

and all other documents like BMR and BPR are prepared using MFR by the
manufacturing units.

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 PREPARATION OF
MFR
Product Manufacturing Packagin
details process g
process

Flow Calculations Yield

chart

Specia
Equipmen
instructions
l
t

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 BATCH FORMULA RECORD
A batch manufacturing record is a document designed to provide a
complete record of the manufacturing history of a batch of product.

The US Food and Drug administration defines a batch as “a specific

quantity of a drug or other material that is intended to have uniform
character and quality, within specified limits, and is produced according to a
single manufacturing order during the same cycle of manufacture”.

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 PREPARATION OF BMR
They normally contain information that relates to the following aspects of the manufacture of a batch of
product:
 Dates of start and finish of manufacture.

 Lists all materials used and amounts of each used.

 Lists of packaging materials used.

 Details of the steps completed in the manufacturing process and times of completion.

 Initials of the person responsible at every stage.

 Details and results of all in-process checks.

 Reference to any equipment used.

 Batch yield and reconciliation.

 Any deviations.

 Quality Control information.

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 QUALITY AUDIT PLAN AND REPORTS
Conducting internal audits (self inspections) and external audits of
suppliers and outsourcing operations are key elements of a good quality
system.
One aspect of a quality system that is identified in the recently released
International Conference on Harmonisation (ICH) Q10, “Pharmaceutical
Quality System”, and in other quality system standards such as ISO 9001, is
that of conducting audits as a means of evaluating compliance with the
objectives of the quality system.
Implementation of the quality management system model defined in ICH
Q10 should result in achievement of the three main objectives stated in ICH
Q10: Achieve product realization, establish and maintain a state of control,
and facilitate continual improvement.
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 Documentation and communication
 The audit results should be documented and communicated to management.
The method of documentation and communication including the security and confidentiality of
the audit reports should be defined in the procedure.
 It is important to remember that those responsible for the audited operation should always
receive a copy of the report, including outsourcing management and supplier management.
Such reports should clearly describe the audit team observations including specific examples
when possible.
If commitments have been made to implement corrective actions, such commitments should
be included in the report.
 Security of audit reports should be strictly enforced and distribution of the report should be
limited.
When providing audit reports to external sources such as outsourcing companies or suppliers, a
subset of the internal report may be provided as long as the observations are included

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 SPECIFICATION AND TEST PROCEDURES
A specification is defined as a list of tests, references to analytical
procedures, and appropriate acceptance criteria, which are numerical limits,
ranges, or other criteria for the tests described.
It establishes the set of criteria to which a drug substance or drug product
should conform to be considered acceptable for its intended use.
"Conformance to specifications" means that the drug substance and / or
drug product, when tested according to the listed analytical procedures, will
meet the listed acceptance criteria.
Specifications are critical quality standards that are proposed and justified
by the manufacturer and approved by regulatory authorities as conditions
of approval.

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 Release vs. Pharmacopoeia
Design and Limited data
Periodic or skip shelf-life Parametri Alternative l tests and Evolving Referenc
In-process tests development available at
testing acceptanc c acceptance technologie e
consideration filing
e criteria release procedure criteria s standard
s
s

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 PROTOCOLS AND REPORTS
A protocol is a written statement to conduct the process along with the
procedure, test method, equipment handling, specifications, acceptance
criteria, report and approval.

The report summarizes all results, gives recommendations for fixing errors
and/or improving the overall quality of the speech corpus and gives an
executive summary.

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 DISTRIBUTION RECORDS
Distribution forms an important activity of the integrated supply chain management of
pharmaceutical products.
 Various persons and entities are often responsible for the handling storage and
distribution
of such products.
 The guidelines are intended to apply to all steps in the entire distribution/supply chain
Permanent information, written or electronic, should exist for each stored product
indicating recommended storage conditions, any precautions to be observed and retest
dates.
Pharmacopoeial requirements and current national regulations concerning labels
and containers should be respected at all times.
 Procedures should be in place for temperature mapping, security services at
the
warehouse,
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destruction of unsaleable stocks and on retention of the records.
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 ELECTRONIC DATA
Electronic data can stand for
 data in general that is exchanged via electronic communication lines
 digital data in particular
 Data (computing), i.e. computer - processable data as opposed to executable code
The Pharmaceutical industries are in a highly regulated environment, hence it requires effective
document management processes.
Having timely accurate data is critical for the success of any company.
Data has never been easy to manage, and is especially true in pharmaceutical industry.
Note that electronic information includes everything such as emails, adverse event reports,
complaints, batch records, quality control records - everything that is stored electronically.
Several technologies are being used currently in pharmaceutical industry to manage their huge
volumes of data generated on daily basis.

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 CONCLUSION
Just as with GMPs, the goal of implementing strict compliance with GDPs
will help pharmaceutical companies establish consistent practices that will
minimize risk of misinterpretation, errors in communication and ensure
product quality.

Setting and following good document practices is not only an essential

aspect of compliance with federal regulations, but also critical to consumer
health.

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 THANK
YOU

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