The document provides guidance on good documentation practices for pharmaceutical manufacturing. It discusses the importance of documentation and outlines key requirements for documents and records to ensure data integrity. These include maintaining batch records, equipment cleaning records, raw material records, production instructions, laboratory testing records, and conducting batch record reviews. Documentation must be accurate, contemporaneous, attributable, complete, consistent, enduring and readily available. All activities should be properly documented at the time they are performed and any changes must be justified and traceable. Good documentation practices are necessary to demonstrate compliance and allow for traceability in the pharmaceutical quality system.

1. DOCUMENTATION
M. S. K. Anwar
Drug International Ltd. (Herbal Division)

2. HEADLINE
Introduction
Aims and Objectives
Documents & Record to be maintained
Observation on Poor Documentation Practice
Good Documentation Practice (GDocP)
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3. Introduction:
“ IF YOU HAVE NOT DOCUMENTED ANACTIVITY, YOU HAVE NOT DONE
IT ”.
Document all the activities performed
Do not perform the activity if it is not documented.
As per GMP documentation control -
“If it is not written down, then it did not happen”.
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4. Introduction (cont..)
Documents: An approved instruction either in paper or electronic form
which guides about how an activity shell be executed.
The document provides -
• Information on when, where who, why and how to complete the task.
• evidence proving that the tasks have been completed as they should be.
Records: Records provide evidence that activities have been performed or
result have been achieved.
- A record is often considered as document.
- They always document the past.
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5. Aims and Objectives
• Compliance to regulatory requirement - No observation
/warning letters / Import Alert / ban
• Build confidence on System & practice
• Correct, complete, current and consistent information
• Effectively meets customers and stakeholders' requirements.
• Ensure the traceability
• Useful for review, investigation & CAPA
• Solve complex problems
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6. Aims and Objectives (Cont.…)
• Reduce or eliminate assumption and second-guessing
• Eliminate the need to re-ask the same questions
• Specify clear instructions to staff
• Consistent quality, yield and performance of staff.
• Provide background history (Information storage point for anyone to
access. Information can be added at any time, providing a full history.)
• Preserves learning and knowledge (Reference for future use or a
means to communicate information to others. Particularly important to ensure
that knowledge is not lost when an employee leaves.)
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7. Documents & Record to be maintained
• Batch Record Forms/BMR/BPR
• Bills of Materials (BOMs)
• Specifications
• Policies
• Protocols
• Standard Operating Procedures
(SOPs)
• Work Instructions (WIs)
• Test Methods
• Checklists
• Forms/Log sheets
• Training Assessments
• Calibration Records
• Maintenance Records
• Non-conformance
• Change control
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8. Documents & Record to be maintained (Cont.…)
• Electronic and hardcopy Quality
records (e.g. non-conformance,
corrective and preventative actions,
internal inspection, change control, training
records etc.)
• Certificate of Analyses (CoA) or
Certificate of Compliance (CoC)
• Technical transfer reports
• Validation documentation
• Annual self inspection record
• CAPA (Corrective Action and
Preventive Action)
• Clinical study record
• Complaints and Complaint
handling/ monitoring
• Deviation
• Laboratory Notebooks/ Logbooks
• Labels (Product Labels/ Status
Labels)
• Quality Management records
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9. Observation on Poor Documentation Practice
 Missing signatures and dates at the time of activity performed.
 Non-uniform date and signature
 Activity was done & writing on one day and signed on another day.
 Blank spaces
 Illegible writing
 Too many corrections
 Write-overs, Multiple line-through
 "White-out" or other masking device
 Error correction not signed / dated, and reason for the correction not
written
 Not traceable
 Data integrity
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10. Observation on Poor Documentation Practice (Cont.…)
Why do people sometimes fail to
document activities or events properly?
 People do not clearly understand what or when to document.
 Procedures may not be completely understood or followed.
 People are not always held accountable.
 People will make mistakes.
 People don't always make corrections properly.
 People do not relate to auditing.
 People do not understand the legal role of documentation.
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11. Good Documentation Practice (GDocP)
Personnel should follow GDocP for both paper records and electronic
records in order to assure data integrity. These principles require that
documentation has the characteristics of being attributable, legible,
contemporaneously recorded, original and accurate (sometimes
referred to as ALCOA).
ALCOA-plus: A commonly used acronym for “attributable, legible,
contemporaneous, original and accurate”, which puts additional
emphasis on the attributes of being complete, consistent, enduring and
available – implicit basic ALCOA principles.
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12. Good Documentation Practice (GDocP)
Attributable: Attributable means information is captured in the record so that it is
uniquely identified as executed by the originator of the data (e.g. a person or a
computer system).
Legible, traceable and permanent: The terms legible and traceable and permanent
refer to the requirements that data are readable, understandable, and allow a clear
picture of the sequencing of steps or events in the record.
Contemporaneous: Contemporaneous data are data recorded at the time they are
generated or observed.
Original: Original data include the first or source capture of data or information and all
subsequent data required to fully reconstruct the conduct of the GXP activity.
Accurate: The term “accurate” means data are correct, truthful, complete, valid and
reliable.
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13. Good Documentation Practice (GDocP)
 Documentation must be-
 Accurate: true / precise, error free,
 Concise: short & clear information that is understood by all
 Legible: shall be readable, understandable.
 Traceable: who recorded it, where, when and how
 Contemporaneous: Documented at the time activity done
 Enduring: Long lasting and durable
 Accessible: Easily available / retrievable
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14. Good Documentation Practice (GDocP)
 Basic Principle
 Always record the entries at the time of activity simultaneously.
 Record data with the signature in GMP documents.
 Never sign for someone else on any document. Only sign for the
work that you have performed yourself.
 A document with original signatures should never be destroyed.
 Use an indelible ballpoint pen to record data in GMP document.
 Never use a pencil or erasable or water-soluble ink pen to
complete the GMP record.
 When one or more person complete the task, all person must
sign.
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15.  Basic Principle (Cont.…)
 Never do white-out or correction fluid or cover-over-tapes to
correct the entry in GMP records.
 No space, lines or fields are to be left blank
 Never falsify information and over-write a record.
 Never backdate GMP records.
 Never use symbols e.g. Ditto marks or arrows to indicate
repetitive and consecutive entry.
 Never discard or destroyed any GMP record unless retention
period expiry is reached.
Good Documentation Practice (GDocP)
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16.  Record writing/ Data Entry
Use a non-water soluble pen for writing on any official document.
 Use Ball point pens of blue or black colored inks to make entries.
 Don’t use pens like gel pens, ink pens for making entries.
 Don’t use pens like red, green color ink.
 Do not use pencil or ink that can be erased.
Good Documentation Practice (GDocP)
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17.  Record writing/ Data Entry (Cont.…)
 Space and cells cannot be left “Blank”
 When spaces or cells do not contain information, Each must contain the
appropriate “Not Applicable” entry Or N/A.
 Blank/Unused space in the GMP document should be strikeout with single
line with sign and date to ensure that record cannot be added at a later date.
 This rule applies to all product-related documents -
Electronic and written.
Good Documentation Practice (GDocP)
N/A
Sign & Date
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18.  Record writing/ Data Entry (Cont.…)
 Never use ditto
 Never use lines (with or without arrows) to show a
continuation of values or entries in a column or row
 Never mask the original entry.
 Never use Correction liquid, tape, or materials
Good Documentation Practice (GDocP)
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19.  Record writing/ Data Entry (Cont.…)
Correction of entry must be made properly
 Should not be overwritten or blocked to make it
unreadable. (Don’t turn a “6” or “9” into an “8”.)
 Use a single strike outline to mark the incorrect entry
in such a manner that entry remains readable, enter
correct information above or to the side of the
incorrect entry.
 Write initials and date of correction. Write justification
if possible.
 When two people signed the original entry and then
another changes the entry, the second person must
also sign for the change.
Good Documentation Practice (GDocP)
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20.  Record writing/ Data Entry (Cont.…)
Illegible: Clearly Record the Data
What’s that number?
27? 29? 24? 2%
Hmmm. What do we do now?
Suppose this is a final product, and the specification is 27
29 is acceptable.
But what if it’s 24? Now what?
We might have to reject the entire experiment and redo
Good Documentation Practice (GDocP)
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21. ICH-Q7: 6. Documentation and Record
6.1 Documentation System and Specification
6.10 All documents should be prepared, reviewed, approved and distributed according to written
procedures.
6.11 The issuance, revision, superseding and withdrawal of all documents should be controlled with
maintenance of revision histories.
6.12 A procedure should be established for retaining all appropriate documents until specified
retention period.
6.13 All documents should be retained for at least 1 year after the expiry date of the batch. For APIs
with retest dates, records should be retained for at least 3 years after the batch is completely
distributed.
6.14 Corrections to entries should be dated and signed and leave the original entry still readable.
6.15 During the retention period, originals or copies of records should be readily available
6.16 Specifications, instructions, procedures, and records can be retained either as originals or as
true copies.
6.17 Specifications should be established and documented for raw materials, intermediates where
necessary, APIs, and labelling and packaging materials.
6.18 If electronic signatures are used on documents, they should be authenticated and secure.
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22. 6.2 Equipment Cleaning and Use Record
6.20 Records of major equipment use, cleaning, sanitization and/or
sterilization and maintenance should show the date, time (if
appropriate), product, and batch number of each batch processed
in the equipment, and the person who performed the cleaning
and maintenance.
6.21 If equipment is dedicated to manufacturing one intermediate or
API, then individual equipment records are not necessary if
batches of the intermediate or API follow in traceable sequence.
In cases where dedicated equipment is employed, the records of
cleaning, maintenance, and use can be part of the batch record or
maintained separately.
ICH-Q7: 6. Documentation and Record
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23. 6.3 Records of Raw Materials, Intermediates, API Labelling and Packaging
Materials
6.30 Records should be maintained including:
 Manufacturer Name, Identity and quantity of raw materials, intermediates
or labelling and packaging materials for API's; the name of the supplier; the
supplier's control number(s), if known, or other identification number; the
number allocated on receipt; and the date of receipt;
 The results of any test or examination
 Records tracing the use of materials
 Documentation for conformity with established specifications; and
 The final decision regarding to rejected
6.31 Master (approved) labels should be maintained for comparison to issued
labels.
ICH-Q7: 6. Documentation and Record
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24. 6.4 Master Production Instructions (Master Production and Control Records)
6.40 To ensure uniformity from batch to batch
6.41 Master production instructions should include:
- The name of the intermediate or API and an identifying document
reference code, if applicable;
- A complete list of raw materials and intermediates designated by names or
codes sufficiently specific to identify any special quality characteristics;
- An accurate statement of the quantity or ratio of each raw materials,
Where the quantity is not fixed, the calculation for each batch size or rate
of production should be included;
- The production location and major production equipment to be used;
- Detailed production instruction;
- Special notations and precautions to be followed;
- Instructions for storage, and special storage conditions with time limits;
ICH-Q7: 6. Documentation and Record
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25. 6.5 Batch Production Records (Batch Production and Control Records)
6.50 Should be prepared and include complete information relating to the
production and control of each batch. should be checked before issuance to
assure that it is the correct version and a legible accurate reproduction of
the appropriate master production instruction.
6.51 Record should be numbered with a unique batch or identification number,
dated and signed when issued.
6.52 Documentation of completion of each significant step should include:
- Dates and, when appropriate, times;
- Identity of major equipment (e.g., reactors, driers, mills, etc.) used;
- Specific identification of each batch, including weights, measures, and batch
numbers of raw materials, intermediates, or any reprocessed materials used
during manufacturing;
- Actual results recorded for critical process parameters;
- Any sampling performed;
ICH-Q7: 6. Documentation and Record
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26. 6.5 Batch Production Records (Batch Production and Control Records) (Cont.….)
- Signatures of the persons performing and directly supervising or checking
each critical step in the operation;
- In-process and laboratory test results;
- Actual yield at appropriate phases or times;
- Description of packaging and label for intermediate or API;
- Representative label of API or intermediate if made commercially available;
- Any deviation noted, its evaluation, investigation conducted (if appropriate)
or reference to that investigation if stored separately; and
- Results of release testing.
6.53 Written procedures should be established and followed for investigating
critical deviations or the failure of a batch to meet specifications. The
investigation should extend to other batches that may have been associated
with the specific failure or deviation.
ICH-Q7: 6. Documentation and Record
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27. 6.6 Laboratory Control Records
6.60 Laboratory control records should include complete data derived from all tests
conducted to ensure compliance with established specifications and standards,
including examinations and assays, as follows:
− A description of samples received for testing,
− A statement of or reference to each test method used;
− A statement of the weight or measure of sample used for each test
− A complete record of all raw data generated during each test,
− A record of all calculations performed in connection with the test,
− A statement of the test results and how they compare with established acceptance
criteria;
− The signature of the person who performed each test and the date(s)
− The date and signature of a second person showing that the original records have
been reviewed for accuracy, completeness, and compliance with established
standards.
ICH-Q7: 6. Documentation and Record
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28. 6.6 Laboratory Control Records (Cont.….)
6.61 Complete records should also be maintained for:
− Any modifications to an established analytical method;
− Periodic calibration of laboratory instruments, apparatus, gauges,
and recording devices;
− All stability testing performed on APIs; and
− Out-of-specification (OOS) investigations.
ICH-Q7: 6. Documentation and Record
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29. 6.7 Batch Production Record Review
6.70 Written procedures should be established and followed for the review and
approval of batch production and laboratory control records, including
packaging and labelling, to determine compliance of the intermediate or API
with established specifications before a batch is released or distributed.
6.71 Batch production and laboratory control records of critical process steps
should be reviewed and approved by the quality unit(s) before a batch is
released or distributed. Production and laboratory control records of non-
critical process steps can be reviewed by qualified production personnel or
other units following procedures approved by the quality unit(s).
6.72 All deviation, investigation, and OOS reports should be reviewed as part of
the batch record review before the batch is released.
6.73 The quality unit(s) can delegate to the production unit the responsibility and
authority for release of intermediates, except for those shipped outside the
control of the manufacturing company.
ICH-Q7: 6. Documentation and Record
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30. Questions ??
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31. 31