3. Why GDP is important
Proverb:
“IF YOU HAVE NOT DOCUMENTEDAN
ACTIVITY,
YOU HAVE NOT DONE IT”.
Document all the activities performed
Do not perform the activity if it is not
documented.
4. Definition
Documents:
An approved instruction either in paper or electronic
form which guides about how an activity shall be
executed.
Records:
• Records provide evidence that activities have been
performed or results have been achieved.
A record is often considered as document.
They always document the past.
5. Documentation must be;
Accurate : true / precise, error free,
Concise: short & clear information that is understood by all
Legible: shall be readable , undertanadable.
Traceable: who recorded it, where, when and how
Contemporaneous: documented at the time activity done
Enduring: Long lasting and durable
Accessible: Easily available / retrievable
What is Good Documentation Practice
Shall be Complete & Authentic:
6. Principles of GDP
A document with original signatures should never be
destroyed.
Never falsify information
Never do white-out and cover-over-tapes
Never obliterate information or record
Never over-write a record.
Never use pencil – use permanent ink for writting
No spaces, lines or fields are to be left blank
Never use symbols e.g ditto marks or arrows to indicate
repetitive and consecutive entry
7. Observations on Poor Documentation Practices
Missing signature and dates at the time of activity performed.
Non-uniform date and signature
Activity was performed & 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
8. Benefits of GDP
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 complicated problems
Reduce or eliminate assumptions and second-guessing.
Eliminate the need to re-ask the same questions
Specify clear instructions to staff
Consistent quality, yield and performance of staff.
9. Q7: DOCUMENTATION AND RECORDS (6)
A. Documentation System and Specifications (6.1)
1. All documents should be prepared, reviewed, approved, and distributed.
2. The issuance, revision, superseding, and withdrawal of all documents should be
controlled by maintaining revision histories.
3. A procedure should be established for retaining until specified retention periods
4. When entries are made in records, these should be made
indelibly in spaces provided for such entries, directly after
performing the activities, and should identify the person
making the entry.
5. Corrections to entries should be dated and signed and leave
the original entry still legible.
6. During the retention period, originals or copies of records
should be readily available
10. Q7: DOCUMENTATION AND RECORDS (6)
B. Equipment Cleaning and Use Record (6.2)
1. Records of major equipment use, cleaning, sanitation, 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.
2. If equipment is dedicated to manufacturing one intermediate or API,
individual equipment records are not necessary
3. In cases where dedicated equipment is employed, the records of
cleaning, maintenance, and use can be part of the batch record or
maintained separately.
11. Q7: DOCUMENTATION AND RECORDS (6)
C. Records of Raw Materials, Intermediates, API
Labeling and Packaging Materials (6.3)
Records should be maintained including:
• The name of the manufacturer, identity, and quantity of each
shipment of each batch of raw materials, intermediates, or
labeling and packaging materials for API's; and date of receipt.
• Inspection & test, status of incoming materials;
• Records tracing the use of materials;
• Documentation of testing and review for conformity with
specifications;
• Status: approved / rejected
• Master (approved) labels should be maintained for comparison
12. Q7: DOCUMENTATION AND RECORDS (6)
E. Batch Production and Control Records (6.5)
(i) Actual results recorded for critical process parameters, time,
quantity measured, equipment used, sample,
(ii) Process parameters- temperature, pressure, pH etc
(iii) Signatures of the persons performing and directly supervising
or checking each critical step in the operation,
(iv) In-process and laboratory test results,
(v) Actual yield at appropriate phases or times,
vi) Description of packaging and label
vii) (vii) Any deviation noted, its evaluation, investigation
conducted (if appropriate) or reference to that investigation
13. Q7: DOCUMENTATION AND RECORDS (6)
F. Laboratory control records (6.6):
Laboratory control recordsshould include complete data derived from all
tests conducted to ensure compliance
•A description of samples received for testing, including the material name
or source, batch number or other distinctive code, date sample was taken,
and, where appropriate, the quantity and date the sample was received for
testing;
•Statement of or reference to each test method used;
•Statement of the weight or measure of sample used for each test as described
by the method; data on or cross-reference to the preparation and testing of
reference standards, reagents and standard solutions;
•Complete record of all raw data generated during each test, in addition to
graphs, charts and spectra;
14. Q7: DOCUMENTATION AND RECORDS (6)
F. Laboratory control records (6.6): contd
•A record of all calculations performed in connection with the test, including, for
example, units of measure, conversion factors, and equivalency factors;
•The signature of the person who performed each test and the date(s) the
tests were performed;
•The date &signature of a second person who is reviewed for accuracy,
completeness, and compliance with established standards.
•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;
• Out-of-specification (OOS) investigations.
15. GMP- Documentation Requirements
•Keep in mind, after the product is released and
shipped to the customer, what remains behind is
the Document.
•Documentation / record is useful to us ONLY if it is
100% accurate.
•So it is important for us to understand and
•follow the Good Record Practice.
Records
Batch
500507
17. Why do people sometimes fail to document activities or
events properly?
People don’t clearly understand what or when to document.
Procedures may not be completely understood or followed.
People aren’t always held accountable.
People will make mistakes.
People don’t always make corrections properly.
People do not relate records to auditing.
People don’t understand the legal role of documentation
18. Record Keeping System
How do maintain the record
Bound notebook pre-numbered
loose sheets (Pre-numbered, the printing have to
be controlled and also the storage as control
records)
Every register Forms shall have
Format / control number / header
Date of opening
Date of closing
Table of content where applicable
19. Record writing /Data Entry
Enter complete and accurate information at the time
work is performed.
Enter signature or initials (according to procedure)
When one or more person complete the task, all
person must sign.
Never sign your name for performance of a job for
work actually performed by someone else.
Limit the use of abbreviations and acronyms.
20. Record writing /Data Entry
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.
Use a non-water soluble pen for
writing on any official document.
21. Record writing /Data Entry
Spaces 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
This rule applies to all product-related documents -
electronic and written.
22. Record writing /Data Entry
Never use ditto
Never use lines (with or without arrows) to
show a continuation of values or entries in a
column or row.
23. Record writing /Data Entry
Corrections to written records must be
made properly.
NEVER mask the original entry.
NEVER USE “correction” liquid, tape,
or material.
24. Record writing /Data Entry
Corrections to written
records must be made
properly.
DO NOT USE “write-
overs” (Don’t turn a
“6” or “9” into an
“8”.)
Never vary your
initials or signature
25. How to make Corrections
When an entry or calculation must be corrected, follow these steps:
•Draw a single line through the incorrect entry.
•Enter correct information above or to the side of the incorrect
entry.
•Write your 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.
Here’s how a corrected entry might look:
Weight of ingredient 14.5 kg 14.75 kg Ams 19.08.2016
Don’t Deface the original Entry!
26. GDP: Error Description
The following are the example of notations that may be
used to describe error corrections.
Calculation error
Transposition
Illegible entry
Wrong entry
28. 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
This consumes time and resources.
Avoid sloppy writing
Similarly try to write in Caps where possible
Consequence of illegible writing:
29. Good Documentation Practice
Computer print outs taken on thermal
paper or easily fading inks should be
photocopied and maintained.
Original shall be destroyed after verification
Use polyvinyl alcohol base gum or white
glue for pasting of graphs etc
Use clear transparent tape for mending
(patch-up).
30. Good Documentation Practice
Don’t do ….
Don’t remove any pages or portions from a note book
Don’t make any temporary entries in a bit of paper of
hand
Preserve the notebooks intact.
Do Not Use “Sticky” Notes.
Do Not Back-Date Or Post-Date.
Do Not Use Asterisks That May Cause Confusion (Such As
Using The Same Asterisk For Different Footnotes).
Do Not Transcribe Data.
Avoid Use of Unbound Laboratory Notebooks
31. Recreating And Rewriting Records
Recreating or rewriting records should be avoided.
If necessary to do this;
The supervisor and QA Approvals are required when
recreating records.
It is important to identify the recreated document as
“rewrite” and to reference the sources of the information.
Records can be recreated only when:
1. The original record is illegible
2. An incorrect form or document was used
3. The record is reparable
4. The original was in A format that would not keep (thermal paper
strips)
32. Good Documentation Practice
Lab record:
Enter enough details so the document can be
understood in the future.
Documents should be signed and dated by the
person who performed the test.
A reference to the identification of the sample
analysed should be included.
33. Good Documentation Practice
Witnessed / Checked/ reviewed by
• The second check : When one person performs the task and
the second person verifies that it has been performed
correctly.
• Double checking our work provides additional assurance that
no mistakes were made.
• The person who is the “verifier” must be clear as to what
they are verifying by affixing their signature to the
document.
• Examples: charging of raw materials ; Monitoring critical
parameters
34. Good Documentation Practice
Reviewer:
Must be verified by a second person
Signature of the person verified
Verify within a time frame
Review he documentation:
• BPRs, Test record, material issue, Cleaning
records, calibration and equipment
records, raw data, yield & Calculations etc
35. Good Documentation Practice
Review of the original records when the records are
complete / after complete analysis of a sample has been
performed.
All raw data, all printed / electronic data
Chromatogram, spectrum weight prints, This can be done on
a sheet/record where all results have been summarized
If a notebook is no longer used and unused pages are
remaining
Draw a line across the first unused page
Indicate “the remainder of the note book is not used”
Sign with date
36. Good Documentation Practice
Check the following during review:
Missing records and out-prints
Incomplete entries
Illegible corrections
Cross References
Deviations, if any investigation the impact on the product
Valid calibrations and service intervals of test equipment
Compliance with specifications, parameter ranges or
acceptance criteria including tighter customer
specifications
37. Good Documentation Practice
Examples of deviations are:
Incorrect charging of raw materials.
Temperature, pressure, vacuum parameters outside
defined limits.
Operating instructions not correctly followed.
Breakdown of equipment or failure of utilities.
Equipment out of calibration.
Records not adequately completed.
Temporary alteration to defined instructions
In Process Control Limits not achieved.
Extraneous contamination of API and intermediates
Any other unplanned event.
38. Good Documentation Practice
Errors or mistakes are possible – person recording is human
Correction, corrective action and preventive action
List the documentation errors /mistakes/ deviation
Classify and trend
Train the persons
Correction where possible
Report the deviation to QA
Investigation & root cause
Understand issue & take CAPA
39. Good Documentation Practice
ICH Q7: 6 Documentation And Records
21CFR 211.180(d) …These records or copies…shall be subject
to photocopying or other means of reproduction as part of
such inspection.
Records that can be immediately retrieved from another
location by computer or other electronic means shall be
considered as meeting the requirements of this paragraph.”
Store the documents & records in secured place until
retention period
Document Retention & Retrieval:
40. GDP Implementation
Swear to record the actual
information/ data
Be honest
Strengthen the review
Report the deviation
Train the operators or
chemists on common /
identified mistakes or errors
41. All this is achievable through
Positive attitude
Positive thoughts
Removal of mental blocks
Open or willing to change
Understand the need of business
Destruction of Ego
42. Good Documentation Practice
Documentation is a record of our product history.
GMP documents are legal documents & requirement.
The “double check” (review) assures that our work is
correct.
All work should be documented at the time work is
performed.
Correct the errors properly
Report the deviations if any and implement the CAPA
Train all the staffs on GDP and explain the consequences.
Summary
INSTRUCTOR’S NOTES:
Welcome to GMP Training on the topic of Documentation Requirements.
We will look at - FDA view of documentation
- Specific and UCP documentation practices
- and practice proper documentation exercises
What is the FDA’s view of documentation? NOT WRITTEN, DIDN’T HAPPEN
Documentation includes any records having to do with the manufacture of a drug product from Raw Material arrival to Distribution.
What are some examples of records where we document?
- Batch Production Recordchange request forms
- test resultsdeviation reports
- shipping, receiving recordslab notebooks
- training records Analytical Data sheets