GMP Documentation

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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)
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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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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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• 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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• 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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U
S
P
B
P
DR

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

19. Checking Work Station:
Before any processing begins,
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• 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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•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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•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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•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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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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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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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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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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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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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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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