Good Documentation Practice

Dr. A. Amsavel
Index
Introduction
Definition
Documents required
Records to be maintained
Good Documentation practice
 Why GDP is important
Proverb:

“IF YOU HAVE NOT DOCUMENTED AN

ACTIVITY,

YOU HAVE NOT DONE IT”.

Document all the activities performed

Do not perform the activity if it is not
documented.
 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.
 What is Good Documentation Practice
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

Shall be Complete & Authentic:

 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
 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
 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.
 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
 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.
 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
 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
 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;
 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.
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 Records

Batch
•follow the Good Record Practice.
500507
 Poor documentation


?
Why do people sometimes fail to document activities or
events properly?
 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
 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

 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.
 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.
 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.
 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.
 Record writing /Data Entry
Corrections to written records must be
made properly.

NEVER mask the original entry.

NEVER USE “correction” liquid, tape,

or material.
 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
 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.
Weight of ingredient 14.5 kg 14.75 kg Ams 19.08.2016
Here’s how a corrected entry might look:

Don’t Deface the original Entry!

 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
 GDP: Illegible
Clearly Record the Data

What’s that number?

27? 29? 24? 2%

Hmmmm. What do we do now?
 Consequence of illegible writing:

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

 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).
 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
 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)
 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.
 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
 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
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
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
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.
 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
Good Documentation Practice
Document Retention & Retrieval:
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
 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
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
Good Documentation Practice
Summary
 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.
Questions??
Thank you