Basic Principle of GDocP, Good Documentation Practices, ALCOA, ALCOA+, MHRA and Eudralex Guidlines, Effective GDocP, Common GDocP errors, Benefits of GDocP, GDocP Improvement, GMP, Pharmaceutical

1. GOOD
DOCUMENTATION
PRACTICES
In Pharmaceutical Industry

2. Overview
1. Guidelines
2. What is Good Documentation Practices (GDocP)?
3. Common GDocP errors
4. Examples of error
5. Benefits of GDocP
6. GDocP improvements

3. Good Documentation Practices
If it is not written down, then it didn’t happen
Document all the activity performed
Do not perform the activity if it is not on written instruction

4. Guidelines
 Eudralex Vol.4 GMP chapter 4 – Documentation
 MHRA GxP Data integrity Guidance and Definitions

5. What is Good Documentation Practices (GDocP)?
 GDocP are those measures that collectively and individually ensure Documentation,
whether paper or electronic are following the principles of ‘ALCOA+’
 Documents use for GMP purpose should comply with GDocP i.e. BMR, logbook,
Specification, SOP, Analytical method, Protocol, Qualification Doc, CofA, TA, PQR
 Document handling procedure i.e Retention, Archiving, Periodic review
ALCOA + (Plus)
Attributable Consistent
Legible Complete
Contemporaneous Enduring
Original Available
Accurate

6. Good Documentation Practices
 ALCOA
Attributable – clear who has capture and
document the data
Legible – readable and stay in permanent
format throughout life cycle
Contemporaneous – recorded at the time
of activity
Original – first recorded data, not ‘True
copy’
Accurate – True representation of Fact
 ALCOA+
Consistent – recorded in same way
Complete – Complete pack of data
including metadata
Enduring – long lasting durable storage
(paper, electronic)
Available – Retrievable and accessible for
review

7. Effective Good Documentation Practice
 Document should be designed, prepared, reviewed, distributed in Controlled manner
 All Documents are approved with Effective date stamp
 Easy to understand and follow, orderly fashion
 Periodic review schedule and adherence to it
 Hand written entries should be made in clear, legible, indelible way
 Records should be made or completed at the time each action is taken and in such
a way that all significant activities concerning the manufacturer of medicinal product
are traceable
 Any alteration made to the entry on a document should be signed and dated; the
alteration should permit the reading of the original information. Where appropriate,
the reason for the alteration should be recorded.

8. Common GDocP errors
 Missing Entry
 Incorrect Data
 Calculation error
 Use of uncontrolled/draft version of Document to record raw data
 Poor explanation of an event
 Transcription error / Poor correction
 Discarding raw data due to lack of information on GMP/DI requirement
 Lack of Traceability
All above common errors are directly impact on ALCOA+ principles (Eudralex Ch 4, 4.7 4.8.
4.9)
 Document retention and archiving procedure

9. Example of GDocP error
 Illegible Writing. Is it 29, 27, 24?
 Over writing / Poor correction
 Calculation Error
 Use of Draft unapproved version SOP
A B =(A-B)

10. Benefit of GDocP
 Compliance to Regulatory requirement
 Build Confidence on System and Practice
 Right information
 Effectively meet ‘Right First Time’ on GDocP requirement
 Ensure the Traceability
 Eliminate assumption
 Clear instruction to staff
 Consistent quality, safety of product and performance of staff

11. GDocP Improvement
Interactive
Training
Use recent
onsite
example
Document
revision -
simplification
Precise
sequential
instructions
GDocP
Training
ALCOA+
Representation
of True Data
DI Impact
Compliant
Product
DI
Awareness

12. GDocP Improvement
Quality on the
floor support
Address issue in
timely manner
Online Document
review
Ensure Doc
compliance
Quality
Support
Regulatory
ImpactCompliance
Document approval
Safety and Efficacy of
product
Inspection
observation

13. Good Documentation Practice
Thank you