Importance of Documentation in

GMP compliance
By:
J.Ramniwas
Director-Regulatory and Quality Affairs
Pharmaocean,Vadodara(India)

1
 Objective

• To review general requirements for documents

• To review specific requirements for each document

• To give general guidance how to create good documentation system

•A reliable evidence for GMP compliance.

•Quality by design is the only solution to overcome the quality-related complaints in an
organisation.
•An essential element of quality assurance is good documentation practices.
•The system of documentation devised or adopted should have as its main objective to
establish, monitor, and record “quality” for all aspects of the production, quality control
and quality assurance

2
 Purpose of Documentation

( Clearly written documentation prevents errors that may arise in or

al or casually written communication
( It provides assurance that quality related activities are carried out
exactly the way they have been planned and approved
( The achievement of conformity and quality improvement
( Purpose of documentation :
¾ To ensure that there are specifications for all materials and m
ethods of manufacture and control
¾ Employees know what to do
¾ Responsibilities and authorities are identified
¾ Ensure that authorized persons have all information necessary
for release
¾ Provide audit trail
¾ Forms the basis for improvement.
3
 Quality Based Documentation System

Corporate Communication tool – internal and external

Integral part of corporate interactions

Corporate Policies – Rationale for responsible decision making

Currency of corporation

4
 Quality Policy and its Importance

Management commitment to quality

•Customer Focused
Satisfy our customers' needs and expectations
•Make commitments we fully understand and believe we can meet
•Meet all commitments to customers on time

Performance Driven
1. Verify that our products and services meet agreed requirements
2.Monitor, benchmark and continuously improve our business, products
and services, organization and employees' performance

Achieve Organisation's Mission and Goals

1. Sustain and develop business growth and Intellectual Property

5
 Quality Manual

The strategic document that outlines the organization’s system of

providing quality assurance to achieve customer satisfaction
Objectives :
¾ Describe the quality system structure
¾ Declare the quality policy and organization goal
¾ Describe how the organization meets the quality goal
Content of quality manual :
¾ The quality policy declaration
¾ The goal of quality;
¾ The organisational structure including responsibility and aut
hority of each key personnel
¾ Procedures, instructions and resources for implementing the
quality management.
User :
¾ All personnel in the organization
¾ Another parties, auditors, and customers

6
 Design of Documents

Useful

Flexible

Grow

Change

7
 Type of GMP Documents

1. Description Documents
• Describe how to perform certain tasks
• E.g.. SOPs, Protocols, Specifications, Master Production Records etc.
2. Data Collection Documents
• Facilitate the timely and accurate documentation of tasks and events
• E.g. Forms, Reports, Production Batch Records , Logbooks etc.
3. Numbering Systems
• Serves to account for and track information and documents
• E.g. Lot numbers, Part numbers, equipment numbers, Form numbers, SOP
numbers, Receiving codes etc.
4. Data Files
• Serves to organize the data in to useful categories for review and to support
accountability and traceability requirements
• E.g. Specification Files, Equipment Files, Equipment history files, Product files,
Facility Qualification files etc.

J.Ramniwas 8
 Function of GMP Documents

• Establish, monitor and document Quality

1. Description Documents
Define and establish the Quality of Raw materials, environment, production process
and Finished Product
2. Data Collection Documents
Confirm the materials ,environment , production processes or product routinely meet
the established Quality characteristics.
3. Numbering Systems
Control and track the use of descriptive documents and data collection documents
4. Data Files
Organize the data in to useful categories to facilitate review and retrieval

9
 Users

1. Bottom –up
• Manufacturing, Laboratory or Operational personnel who interact with the detailed
steps of the system on a daily basis
• Need to know what to do and how to do it
2. Top-Down
• Administrative personnel e.g. management, regulatory, development, finance,
marketing who must understand and interact with the system by reference
• A good document is written both to inform and to educate
• It must meet the needs of the line workers and the administrators
E.g. SOP on specification writing- describes the purpose of specifications, provide
guidance on the decision making associated with writing specifications, numbering
systems, change controls and responsible personnel, steps on generating and
approving an SOP etc.

10
 A Well Designed Documentation
System

Ensure Quality standards are met routinely

Minimize the potential for Error

Reduce downtime when deviations or failures occur by providing

immediate access to well organized data

Serve as a consistent training tool for line workers and administrators

GMP documents should be prepared, reviewed, approved, distributed

and archived according to written procedures.

A Poorly Designed System is a burden to all!

A simple system is always the most difficult to design.

J.Ramniwas 11
 Manufacturer's Role

Comply with GMP regulations

Provide Quality medications to patients

Provide documentation to support the quality of the products
from development to market and to product discontinuation

Producing documents is also part of the production

12
Principles of Good Documentation

The heart of GMP is the establishment of well written procedures for each
step of our quality operations

Documentation is used for full traceability of events – cross reference all

related documents – audit

Written procedures provide the controls necessary to minimize the changes,

mix-ups and errors

Ensure compliance with GMP regulations but more importantly, we ensure

the consistent Quality of our products.

13
 Proof of Quality

• As a pharmaceutical company, your proof of success is found in the

documents records that you keep.

• Documentation is your proof that your products/ services are produced in

compliance with the GMP regulations and your company’s operating
procedures and standards.
• Key Documents : Development Records, Clinical Trial Records, process
and method validation, production batch records, OOS, Deviations,
Investigations, Equipment Calibration and preventive maintenance,
Training Records, CAPA, Complaints, Change Control etc..

14
 Who Reads your Documents

Internal
• Colleagues
• Supervisors and managers
• Data Reviewers
• QA
• Global Network Colleagues
External
• Regulators – Local and Foreign
• Customers – Local and Foreign
• Lawyers
• General Public
Write documents as though you are writing history.
Write for future viewers

15
 Basics of Record Keeping

• Where your signature is required, write your name legibly and in

ink – always use include the date of signing.
• Always document as soon as a task is performed
• For all critical steps, a second person is required to verify the
entered data
• Do not document someone else’s work unless you are
designated to do so.
• Do not assume work has been properly documented without
seeing the work and / or the documents, e.g. blame for
fraudulent action

16
 Real Time Formats and Dates

• Data entered directly as it occurs

• Scratch paper or sticky notes must not be used
• Records are signed and dated on the day (and time) the work
was performed
• Consistent date format is important for a company e.g.
day/month/year or year/month/day
• Alpha-numeric dating is preferred
• 01 Nov 2008 is preferred over 01-11-2008
• Each page should have the current date(s) – no back dating.

17
 Calculation and Numbers

Write down the formula and perform one sample calculation.

No calculation is required for simple math

e.g. 1+4 =5

Prevent using down arrow or ditto marks to show repetitiveness

e.g.

18
 Corrections

No over written
No use of white fluid
No out
Critical corrections or omissions must be addressed and signed
by management on raw data record
Data on damaged pages should be re-entered for clarity, initial,
date and explanation
All corrections must be initiated and dated by the analyst and
reviewer when applikable
applicable
John 01 Nov.2008
19
 Documentation Practices

Documentation requires that record, sign and date every step of

the operations that we perform e.g. production batch records
Documentation should always be done promptly, accurately,
legibly and in accord with our written procedures e.g. lab
notebooks
A check list serves as a check and double check against costly
omissions, mix-ups and errors. It is used to avoid mistakes and
ensure completeness of activities
There must be written procedures for process control activities i.e.
SOP. These procedures including changes, must be reviewed
and approved by the organizational unit and QA

20
 Documentation Practices

Permanent ink – No pencil

All pages numbered and filled out consecutively. No blanks to b

e filled in later

Blank or unused pages voided with a line, initiated and dated

Small “fill in the blank” lined out with” “ or “N/A”.

21
 Control of Records

GMP DOCUMENTS shall not leave the company

• Do not take them home

Do not throw away GMP documents

Full reconciliation of each piece of document e.g. sample labels,
chromatograms, investigation report
Archive area
• Security Access
• Document Withdrawal and Return Log
• Smoke Alarms
• Off-site back system for electronic files
• Disaster recovery plan

22
 Electronic /Computerized Records

Records that are required to be maintained under predicate rule requirements

• Maintaining in electronic format in place of paper format – Part 11 records
• Maintain in electronic format in addition to paper format –rely on electronic record to
perform regulated activities ( Business practices) –Part 11 records
• Document the business practices in an SOP
Audit trial for part 11 Records
Backup records are maintained for electronic records
Electronic data must be readily retrievable in a print format
Electronic signatures (e.g. approve, review and verify ) should be authenticated and
secure. When used such a system must be evaluated and tested for security,
validity and reliability, Records of those evaluations and tests must be maintained.
During the retention period such records must be secured and accessible within 48
hours to manufacturer , packager, distributor and importer.

23
 GMP Numbering System

Some documents require two numbers to be identified

completely,
• A document number – tells what it is
• A revision number –tells which one it is

24
 SOP Numbers

Group SOPs by categories

• Personnel
• Quality Assurance
• Quality Control
• Records
• Manufacturing
• Packaging
• Distribution
• Building and facility
• Equipment
• Raw materials and packaging components
• Development
• Engineering
Recommend alphanumeric numbers and revision numbers e.g. QAD
123 v 03

25
 Lot Numbers

Lot numbers are assigned as

• Receiving Lot numbers
• Production / in-house lot numbers
To trace an item or a product from planning , staging, production,
testing to market
To identify an item completely, both the lot number and the part
number are required

26
 Part Numbering System

Part number should be unique to each A Simple Sample Part Numbering System
item
• Sodium Chloride USP Grade – Use in 1000-1999 Raw Materials*
production
2000-2999 Packaging Components*
• Sodium Chloride ACS Grade – Use in
3000-3999 In-process Materials*
laboratories
4000-4999 Printed Materials and
Consider grouping by Suppliers Labels*
ERP,SAP, or Manual Inventory System 5000-5999 Finished Products*
• Numeric Numbering 6000-6999 Materials Prepared
• Alpha-numeric numbering In-house*
Part number can be retired but never 7000-7999 Non-inventory chemicals*
reassign Part numbers 8000-8999 Non-inventory
Components*
* Inventory Items

27
 Document Numbers

Laboratory notebook number

Equipment logbook number
Validation Protocol Number
OOS number
CAPA number
Complaint number
Change number
…… etc

28
Types of Documents in Manufacturing

Labels
Specifications and testing procedures
Master formulae and instructions
Batch processing and batch packaging records
Standard Operating Procedures (SOPs)
Logbooks
Records
Ê Stock control and distribution records
Other documents …

29
 Standard Operating Procedures

Written commitments to regulators that describe the routine tasks

Descriptions on how to perform various routine operations

Step by step instructions that technicians in QC, Production,

maintenance, and material handling consult daily in order to
complete their tasks reliably and consistently

Effective periods and review frequency

30
 SOP Format

Informational Categories
• Title
• Purpose
• Scope
• Responsibility
• Definitions
• Reference/ Applicable Documents
• Safety Considers
• Procedural principles
• Preliminary Operations
• Procedures
• Calculations
• Documentation Requirements
Each Page – Title, SOP number, revision number ,paginations, company name,
declaration of confidentiality
First page –approval signatures, date of approval , issue date, next review date

31
 How to write good SOPs

SOP Numbering – simplify and group similar SOPs together

Reduce duplicate SOPs- facilitate training and improve compliance
Outside the job – Use process flow diagrams
Write for the readers – i.e. operators, analysts, QA, Customers,
Regulators
• Right language
• Short, simple sentences
• Familiar and short words
• Write in conversational style
• Explain the background, Do not assume people know / remember your processes
Use pictures to facilitate understanding, e.g. picture of an HPLC
Put procedures in a good package
• Selling SOPs to employees so that they will follow procedures
• Page design, instructions, table of contents , index , dividers, visual layout, right font
size, and types of binders used, intranet access etc.

32
Specifications and Test Procedures

Primary source of information for an item Purchasing Information

Specification
• Specification number and version control • List of approved vendors
• Description of each part numbered item • Local Supplier – name and address
- Standard Naming convention
• Name of company • Manufacturer – Name and Address
• Expiration date/ Re-test date
• Chemical formula • Minimum Order Quantity
• Material
• Dimensions • Quantity per Unit
• Sampling information e.g. size • Palletization Information
• Handling precautions
• Storage conditions • Certificate of analysis
• Test requirements and method numbers
• Acceptance Criteria • Contracts and Agreements
- Test before release
- Release based on C of A and
concurrent testing
- Release based on C of A and / or ID test
Pagination and approval signatures

33
 Receiving Labels

Each item is labeled with its part number and receiving lot number
• Quantity per unit
• Total Quantity
• Total Number of pallets/ skids
• Responsible person – Initial and Date
• Transportation conditions
Different colors for different types of labels
• Quarantine Label – Yellow Color
• Sampled Label – Blue Color
• Under Hold Label – Orange Color
• Release Label - Green Color
• Rejection Label – Red Color
Barcode Labels
Label issuance, usage, destruction and reconciliation document

34
 Process Development Report

The following exemplifies information to be contained in the development report.

•Historical data of pharmaceutical development of new drug substances and
drug products at stages from early development phase to final application of
approval
•Raw materials and components
•Synthetic route
•Rational for dosage form & formula designs and design of manufacturing methods
•Rational and change histories of important processes and control parameters
•Quality Profiles of manufacturing batches ( including stability data)
•Specifications and test methods of drug substances, intermediates, drug products, raw ma
terials, and components, and their rationale( validity of specification range
of important tests such as contents impurities and dissolution, rational for selectio
n of test methods, reagents and, columns, and traceability of raw data of those
information)
35
 Master Production Records
Prepare , sign and date by one
person and independently
check, sign and date by a
person in the Quality unit
Product Description and item
number
Full list of ingredients
Accurate statement of quantity
or ratio of each raw material or
intermediate to be used
Production location, equipment
and major utilities
Expected production quantity,
sample quantity, rejects,
reprocessed quantity,% yield
Production instructions
Sequences to be followed
•
• Critical steps have to be co-signed
by a second operator/ supervisor
• Define the ranges of process
parameters
• Sampling instructions and in-
process controls with acceptance
criteria
• Time limits for completion of
individual processing steps or total
process
• Expected yield ranges at
appropriate steps
Special storage conditions including
•
labeling and packing materials
• S special precautions
36
 Production Batch Records

Check batch record before issuance to assure the correct version is used- sign
and date when issue
One batch record for one number ( unique number)
For continuous production, the product code with the date and time can serve as
the unique identifier until the final number is assigned
Full traceability of records- dates, times , personnel, equipment, raw materials,
actives, intermediates, packing components, labels, rejects, in-process and lab
results, OOS, investigations, changes, release changes, stability results,
environmental conditions etc…
Investigation of critical deviations – extend to other batches that may have been
associated with the specific failure or deviation
Document all deviations during manufacturing and cross reference to other
documents if necessary e.g. OOS or unplanned deviations
Attach all process generated paper to product batch records e.g. raw material
weighing records, tablet weight check, statistical process control charts,
equipment print outs, equipment and room labels etc.
Record production quantity, sample quantity, rejects, reprocessed quantity and %
yield
37
 Production Record Review

Review and approve by the quality unit to determine compliance wit

h all established , approved written procedures before a batch is rele
ased or distributed
Any unexplained discrepancy or the failure of a batch or of its
components shall be thoroughly investigated, whether or not the bat
ch has already been distributed
The investigation shall extend to other batches
A written record of the investigation shall be made and shall include
the conclusions and follow-up

38
 Packaging Instructions

Master packaging instruction – formally authorized

Packaging instruction
• Strengths, dosage forms, size( by volume, weight or counts), packaging
materials, packaged lot number
• Location of packaging line
• Date, time and personnel
• Labels and print components – keep samples coded with lot number and
expiry date, reconciliation and control
• Line clearance checks – before and after
• In-process controls from shift to shift
• Samples control
• Special precautions

39
 Equipment Records

Usage logs

• Product / Batch Number/ Person/ Date/ Time

Cleaning/ Sanitation/ Sterilization

Maintenance

• Person, date, time, results

Dedicate Equipment – One intermediate or one product

• Individual equipment records are not necessary if batches are traceable

sequence

40
 Laboratory Glassware

All in-process solutions, glassware, media tubes or plates, samp

le extracts and anything used in testing must be clearly labeled
and identified
Laboratory glassware with labels are kept until laboratory
reports are reviewed and approved

Product : ABC
Lot Number : 130
Sample :#1
Analyst initial & Date :

41
 Raw material and Packaging
Component Records

External
• Name(s) of manufacturer/distributor
• Batch Number/ Item Number/ Labeling
• Quantity of each shipment / Quantity per skid / Quantity per unit
• Date of receipt/ expiry date
• Certificate of analysis

Internal
• Receiving Number / Item number/ Labeling
• Sample Size
• Test Specification, Identification/ Test Results and release decision
• Packaging components, printed components and labels
• Master approved labels and components for comparison
• Inventory of each item, usage records for each material and rejection

42
 Laboratory Records

Complete lab data derived from all tests and lab equipment
Compliance with established specifications and standards
Full traceability – dates, time, samples, quantities , suppliers, personnel,
equipment, reference standards, reagents, standard solutions, test
methods, graphs, charts, spectra, chromatograms, calculations,
conversion factors, test results, comparison to previous trends and
validation batches, changes to methods, OOS
Signature of the person who performed each test and the dates(s) the
tests performed
Signature and date of second person showing that the original records
have been reviewed for accuracy, completeness and compliance with
established standards.

43
 Laboratory Data

Raw data are necessary for support, reconstruction and

evaluation of test report

Raw data may include , but is not limited to , photographs,

microfilm, computer printouts, labels, magnetic media, including
dictated observations, and recorded data from automated
instruments

All raw data are kept with the test reports, unless there are
electronic records or other means of recording

44
 Out of Specification and Re-testing

OOS FORM Plus all related documents

Initiate OOS investigation as soon as OOS is found

Any repeat testing or retesting due to laboratory error or instrument

problems must be approved by management prior to testing again

Only management has the authority to invalidate a result

45
 Data Review

ƒ The raw data and lab records are very important

Documents
ƒ Before any product is released to the market, a
complete check of production and laboratory
records is made to make sure the product meets
the quality standards
ƒ When you sign your name on the appropriate
records, you are, in essence becoming an
historian for that process.

46
 Stability Records

Demonstrate that the product meets its established s

pecifications during the product shelf life
Test product in its final package in which it is sold
On-going stability program: 0,3,6,9,12,18,24,36 …mo
nths
Test with in the required time frame

47
 Deviation Records

Deviation Form + all related documents

Full investigation – Describe the background , the environment,
personnel involved, root causes , risk assessment , conclusions,
corrective and preventive actions(CAPA)
Write with short and simple sentences
Write for someone who does not know your procedures
Write for someone who will read this document few years from
now.

48
 Change Control Records
Regulations and Requirements
- Change control as critical part of the
validation life cycle
- How to set up Change Control,
Documentation Systems
- Preparing Change Control SOPS & Forms
- Processes involved to efficiently control
and document changes to:
- Manufacturing processes
- Facilities
- Product
- Elements of Change Control Management
- Change Control process for computerized
systems
- Change Control in API and Drug Product
industries
- How to organize change documentation to
withstand regulatory queries during field
inspections?
-What functions a Change Control system must
perform
- How the organizational culture can affect the
successful implementation of Change Control
- Types of Changes
- Different levels of change (major, minor, critical)
and distinguishing them
- Types of reviews and approvals
- Roles and Responsibilities
Signature meanings
- How your Change Control system may be
examined by investigators
- Change Control checklists
- Personnel Training
- Scale Up and Post Approval Changes – SUPAC
- Bulk Actives Post Approval Changes - BACPAC
49
 Training Records

It is the responsibility of each employee/management to maintain their own

and their department's training records
You can perform a test or task until you and your trainer have completed the trai
ning and signed -off on the procedure.
Certain tests require performance assessment before Qualification
Must document the training on new and revised SOPs issued throughout the ye
ar.
Training Records should be reviewed during annual performance review
between the manager and the employee. Document any additional training
for the new year.
For human errors on OOS or deviations – employee training records need to cro
ss link to corrective and preventive actions.

50
 Organisation Charts

Dated and version control

Name of all personnel involved in GMP activities and
decision making.
Provide information on full time, part time and contract
staff.
Provide global reporting structures for multinational
organizations.

51
 Job Description

Job descriptions are written statements that describe the:

• Duties,
• Responsibilities,
most important contributions and outcomes needed from a position, required qualifications
of candidates, and reporting relationship and co-workers of a
particular job.
Job descriptions are based on objective information obtained through job analysis, an
understanding of the competencies and skills required to accomplish needed tasks, and
the needs of the organization to produce work.
Job descriptions clearly identify and spell out the responsibilities of a specific job.
Job descriptions also include information about working conditions, tools, equipment
used, knowledge and skills needed, and relationships with other positions.
The best job descriptions are living, breathing documents that are updated as
responsibilities change.
The best job descriptions do not limit employees, but rather, cause them to stretch their
experience, grow their skills, and develop their ability to contribute within their
organization.

52
 Technology Transfer Documents

Like for like transfers.

Levels of changes require for changes.
Risk assessment for changes within the “Design Space”
From one site to another site.
From R&D to production
Transfer protocols – before and after
Change control or deviation during transfer
Validation status after transfers
Stability studies

53
 Validation Documentation

Validation Protocol – before validation

• How validation of a particular process will be conducted
• Specify the type of validation e.g. retrospective, prospective or concurrent and the number of
process runs
• Specify critical process steps and acceptance criteria
- Important to put down the pre-determined specifications otherwise , any result can be
claimed as ‘ validated’.
- Important to justify which are the priority parameters to be validated , since we may not be
able to validate all combinations of results

Validation Report – After Validation

• Cross reference the validation protocol
• Summarize the results, deviations, changes and conclusions
• Recommend changes to correct deficiencies
• Justify any variations from the protocol
• Review and approve by the designated units and QA

54
 Management Review Minutes

Attendance
Meeting Dates and Frequency
Discussions of Quality trends and issues
• Identify responsible person(s) for CAPA
• Target dates for actions

Follow-up with previous minutes and actions

Escalation Process

55
Documents involved External Stake Holders

Response to Regulatory Inspections

Responses to customer inspections
Complaints
Product Recalls
Annual Product Quality Review
Post- market adverse drug events reports
Write for the readers
Write for the future

56
Response to Regulatory Inspections

Respond on time
A cover letter and a separate on responses
Understand the GMP aspects of comments and respond to
the comments
Identify root causes
Provide corrective and preventive actions with target dates
Include responsible department/function –names are not
necessary

57
 Complaints

SOPs for handling of all written and oral complaints

Train all employees on how to document complaints
Complaints involving the possible failure of drug product to meet
any of its specifications – to be reviewed by the Quality Control Unit
Complaint represent serious and unexpected adverse drug
experience – require to be reported to FDA
Maintain complaint records at least 1 year after the expiration date
of the product or 1 year after the date that the complaint was
received, whichever is longer
Where investigation is not conducted, the written record shall
include the justification that an investigation was not necessary and the
name of the responsible person making such a determination

58
 Product Recalls

Investigations, root cause analysis, CAPA

Different levels of recalls have different regulatory
requirements
• Class- 1 – Recall from the market place
• Class-2
• Class-3

Distribution records – Full Traceability of Quantities

distributed and the customers
• Includes sales records of drugs and professional samples
• Enable a complete rapid recall of any lot or batch of a drug

59
 Health and Hygiene Records

„ Sanitation and hygiene should be practiced to

avoid contamination of personnel and during
manufacturing of products.
„ It should cover all aspects of manufacturing:
¾ Personnel
¾ Premises
¾ Equipment and apparatus
¾ Production materials and containers
¾ Products for cleaning and sanitation
¾ All potential sources of contamination

60
 Pest and Rodent Control Records

ƒ Written pest control program

ƒ Pest Control and Rodent Control Site map
ƒ Log book of Rodent and Insect Traps
ƒ Insect and Rodent Trap cleaning record
ƒ Outsourcing is recommended
ƒ Use of safe pest control agents
ƒ MSDS of all pest control agents
ƒ No risk of contamination to the materials and
products
ƒ Proper records

61
Regulatory Observation Related to Documentation
Issues

There are no written procedures for production and process controls designed to assure that t
he drug products have the identity, strength, quality and purity they purport to possess.
Written procedures have not been developed for the surveillance, and receipt of post
marketing adverse drug events.
Firm failed to follow their SOPs on OOS investigations. Samples were re-tested before any investigat
ion was conducted.
The operator who manufactured a batch of sterile product has no documented training on
sterile production.
Investigations fail to be conducted within a timely manner. The time frame for completion is required i
n SOP. The SOP places no limitations for the number of times a time frame may be
extended, nor does it identify the number of days allowed to extend a timeframe.
A portion of batch was rejected. The in-process solution made for the rejected portion of the
batch was not reconciled .There was no record of the disposition of the excess quantity of the
excess material.
Lab records are deficient in that they do not include a complete record of all data generated
during testing. There was no record on how many chromatograms were generated.
The firm communicated GMP related information through electronic mails .Investigation and
product decisions were made on emails. Contents of these emails are not archived or
transcribed in to formalized records required by the regulations.

62
Stock Control and Distribution Records

What should be recorded?

Where should records be stored?
Why are the records important?

63
Design a Good Documentation System

Not a one size fits all approach

Unique operations and unique products

Complement the cultural environment of the corporation

Be the expert in your systems, operations, products and

services.

Do not create a system to satisfy one part of the corporation

J.Ramniwas 64
Revision and Renewal of Documents

¾ Should be made periodically, or if needed

¾ Obsolete documents should be retrieved from
all relevant parties and its original copy should
be archived
¾ The date of revision should be stated in the
new documents
¾ Every revision should be approved by
authorized person

J.Ramniwas 65
A Good Documentation Practice:
A Life Style Approach

When you care enough to make GDP a life style and not just a r
egulation, you do more the signing documents – we put our nam
e on job well done.
Write it down – Keep good records
If it is not documented, it is a rumour
There can be no substitute for a clear commitment to entering d
ata
• Correctly
• Completely and
• Chronologically
and right first time

J.Ramniwas 66