1. 1
GDP

2. cGMP DOCUMENTATION
REQUIREMENTS
(Good Documentation Practices)
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3. Document….?
The document is information (meaningful data) and
its supporting medium, which could be..
In paper form,
CD,
Computer Files,
Or Microfilm.
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DOCUMENTATION

4. Documentation..?
is the key to GMP compliance and ensures
traceability of all…
 development,
manufacturing and
testing activities.
provides the route for auditors to assess the overall
quality of operations within a company and the final
product.
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DOCUMENTATION

5. Documentation..?
provides the route for auditors to assess the overall
quality of operations within a company and the final
product.
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DOCUMENTATION

6. Good Documentation..?
An essential part of the quality assurance system.
Clearly written procedures prevent errors resulting
from spoken communication
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DOCUMENTATION

7. Inclusions Of Documentation !!!
The following documents (not limited to it):
Records
Labels
Specifications And Testing Procedures
Master Formulae
Packaging Instructions
Batch Manufacturing Records (BMR)
Batch Packaging Records (BPR)
Standard Operating Procedures (SOPs) 7
DOCUMENTATION

8. Maintenance of Documents:
Documents, as required under local rules*, shall be
meticulously (Thoroughly) maintained
regularly reviewed
kept up-to-date,
(i.e. Document Control System).
* Drugs Rules -1976- Schedule B-II Part I
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DOCUMENTATION

9. Records of Action:
 traceable.
Batch Records :
shall be retained for at least…five year after the expiry
date.
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DOCUMENTATION

10. Documentation Systems:
Data may be recorded by …
Electronic data processing systems or
By photographic or
Other reliable means.
 be Available and
The accuracy of the records shall be checked.
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DOCUMENTATION

11. Only authorized persons shall be able to enter or
modify data in the computer,
Maintain a record of changes and deletion;
Access shall be restricted by;
Passwords or other means
The entry of critical data shall be
independently checked.
Data shall also be readily available.
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DOCUMENTATION

12. Status Identification:…..
Labels applied to…
containers,
equipment,
or premises shall be……
Unambiguous (clear) and
In the Company’s Agreed Format.
Ambiguous Documents
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DOCUMENTATION

13. Status Identification:
The labels of different colors to indicate the status
such as;
“Quarantined - Yellow”,
“Accepted - Green”,
“Rejected - Red”,
may also be used in addition to the wording.
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DOCUMENTATION

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• Name of product
• Ingredients
• Net Content
• Batch number
• Expiry date
• Storage condition
• Information about manufacturing company (Lice. No. and Address)
Finished Product Labeling:
Shall be labeled in accordance with the Drug (Labeling and
Packing) Rules 1986.
DOCUMENTATION

15. Reference Standard Identification: (for QC Lab)
For reference standards, the label or accompanying
documents shall indicate;
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DOCUMENTATION
• Name of material
• Purity/ Potency
• Date of manufacture
• Batch number
• Shelf-life/ Expiry Date
• Storage condition

16. Specification approvals:
Specifications should be available for :
Each specifications shall be;
Approved and,
Maintained by the quality Assurance.
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DOCUMENTATION
• Raw Materials
• Finished Products (Bulk & Intermediate Product)
• Packaging Materials
Bulk & Intermediate Product

17. Revision of Specification:
Periodic revisions to comply with….
new edition of the National Pharmacopoeia or
other Official Compendia or
the Drugs (Specifications) Rules 1978.
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DOCUMENTATION
USP
BP
DR

18. Batch Processing Records:
During processing, the following information shall be;
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DOCUMENTATION
• A batch Processing Record shall be kept for
each batch,
• Transcription Errors

19. Checking Work Station:
Before any processing begins,
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DOCUMENTATION
• A check for previous Products,
• Documents or Materials not required for the planned process,
•Equipment is clean and suitable for use,
•Check shall be recorded

20. Recording Process Operation:
During processing, the following information shall be;
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DOCUMENTATION
• Time of action taken
• Signed by responsible for Operation Completed
• Name of Product
• Batch No.
•Date and time of commencement of significant
stages of production

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DOCUMENTATION
•The name of the person responsible for each
stage
• The initials of the operator(s) of different
significant steps of production
• Person(s) who checked each of these operations
(e.g. weighing);
Recording Process Operation: Continued…

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DOCUMENTATION
• The batch number and /or analytical control
number
• The quantity of each starting material actually
weighed including the…
• Batch/Lot number and
• Amount of any recovered or reprocessed
material added;
Recording Process Operation: Continued…

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DOCUMENTATION
• any relevant processing operation or event,
• the major equipment used;
• the in-process controls performed,
• the initials of the person(s) involved,
• and the result obtained;
Recording Process Operation: Continued…

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DOCUMENTATION
• Yield together with comments or
explanations for significant deviations from
the expected yield; and
• notes on special problems including details,
with signed authorization for any deviation
from the master formula.
Recording Process Operation: Continued…

25. Pre-packaging Line Check:
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DOCUMENTATION
• A batch packaging record shall be kept
• to avoid transcription errors.
Batch Packaging Records:
• A batch packaging record shall be kept

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DOCUMENTATION
• by Name and signature.
• the name of the product,
• the batch number,
• the quantity of bulk product
• the batch number and the planned quantity
of finished product obtained,
• the quantity actually obtained,
• the reconciliation;
Recording of Packaging Operation:

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DOCUMENTATION
• the date(s) and time(s) of the packaging
operations,
• the name of the responsible person,
• batch number,
• the checks for identity & conformity,
including the results of in-process controls;
Recording of Packaging Operation: : Continued…

28. Details of the packaging operations carried out, including…
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DOCUMENTATION
• references to equipment,
• the packaging lines used,
• samples of the printed packaging materials
used,
• expiry date, &
• any additional overprinting;
Recording of Packaging Operation: : Continued…

29. The quantities and reference number ,
Identification of all printed packaging materials
Bulk product issued,
Used, destroyed, or returned to stock and …
The quantities of product obtained to permit an
adequate reconciliation.
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DOCUMENTATION

30. the initials of the persons who performed the testing;
the initials of the persons who verified…
 the testing and
 the calculations, where appropriate; and
A clear statement of Release or Rejection
(or other status decision)
dated signature of the designated person.
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DOCUMENTATION
RELEASED

31. Recording Batch Numbers:
Batch-number shall be recorded
 in a Logbook,
 with product… Logbook
 identity, and
size of batch.
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DOCUMENTATION

32. Recording Batch Numbers:
In addition to the batch number,
references of the relevant specifications
and testing procedures;
test results, including…
observations
calculations,
dates of testing;
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DOCUMENTATION

33. Equipment Logbooks:
Logbooks shall be kept with equipment and
record, as appropriate, any…
 validations,
calibrations,
maintenance, Logbook
cleaning, or
repair operations including dates and the identity of
the person who carried out these operations.
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DOCUMENTATION

34. Equipment Utilization Record:
Use of major and critical equipment,
areas,
Where products have been processed….
shall be …
recorded in Chronological order (In Sequence).
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DOCUMENTATION

35. Reasons for GMP Documentation Requirements
1) Practice Good Business Sense
2) Fulfill Regulatory Requirements
3) Prevent Mix-ups and Errors
DOCUMENTATION

36. Documentation Key Characteristics
To ensure GMP Compliance, all documents
must be:
 accurate
 complete & verified
 clear
 reliable
 legible
 retrievable
 permanent
 current

37. Principles for Good Documentation
Reviewers of documents/records must be
 sufficiently trained.
All errors detected during record review must be
immediately
 Corrected
 Documented
DOCUMENTATION

38. Documents preparation, review, and approval processes
must be
 defined by operating procedure(s).
Documents must be ….
 periodically audited.
Principles for Good Documentation
DOCUMENTATION

39. DOCUMENTATION

40. Basics: Always keep the document concurrent
with process recording information and signing
immediately after the step is performed.
signatures / initials should…
 be legible,
 recorded in the correct blanks,
 Use a permanent ink.
For example;
Black or Dark Blue Permanent Ink is strongly encouraged.
DOCUMENTATION

41. Do not use downward arrow (), “ditto marks”,
or “squiggle s”, to record repeated data in a
column
_______ _________ _________
________ __________ ___________
________ __________ ___________
_________ __________ ___________
________ __________ ___________
JWC 20-Dec-2012 JWC 20-Dec-2012 JWC 20-Dec-2012
DOCUMENTATION

42. Write and record information neatly to make the
document legible
Keep document clean by not placing random marks on it
Document cross-outs and write-overs of digits or
characters correctly, by writing your initials & date of the
correction near the cross out
Incorrect: 187 187
• Do not try to remove all traces of Correction 187
Never use correction ink, correction tape or erasable pens
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JWC 20-Dec-2012
DOCUMENTATION

43. Example 1 4 7 5
Example 2 4 5
Number should be
crossed-out with one
line, initialed and dated.
Unclear what the
number is.
All corrections should be made the same way.
475
485
JWC
20-Dec-2012
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DOCUMENTATION

44.  Measurements:
Ensure that all records include units of
measurement for ….
• volume,
• weight,
• pressure etc.
Examples:
3.56 kg / 300 mL
DOCUMENTATION

45. 1) Follow the organization’s accepted format for
recording dates ..
i.e. dd-mm-yy (04-12-2013) is standard format
Don’t Use mm-dd-yy (12-04-2013) etc.
2) Be consistent…
• across your organization
• in your own work
DOCUMENTATION

46.  Time:
be complete and indicate which part of the day the
operation took place
i.e. 10:08 am or 10:08 pm
 follow the organization’s accepted practice for
recording time format
i.e. 10:08 am or pm
DOCUMENTATION

47. Recording Data and Calculations:
 Ensure that…
• the decimal points are in the correct position.
• the digits in numbers have not been reversed.
• the number of significant digits is correct.
DOCUMENTATION

48. Protect the document from
• spills
• excess folding
• other physical damage
• random marks
A Little Documentation Respect
DOCUMENTATION

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THANKS