Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM). new guidance on good data management was discussed and its development recommended. The participants included national inspectors and specialists in the various agenda topics, as well as staff of the Prequalification Team (PQT)–Inspections

1. Good Documentation Practices

2. Good Documentation Practices
Q. What is GDP?
 Good Documentation Practices
Q. Why GDP is Important?
OK…. Let’s Check The way we understand it..

3. Good Documentation Practices
What is DP?
“Display Picture”

4. Good Documentation Practices
 Why profile pictures are important
One is to help other people to identify you.
Another is to help you express yourself… and
To help others to develop the right impression of you.
Similarly…… GDP is important

5. Good Documentation Practices
Why GDP is Important…
 Similarly…… GDP is important
 To Identify who did what
 To understand what was done
 To evaluate what need to be
 To make a correct interpretation for what it meant for
Because it is the only evidence to show that what we did, is
what we expected to…..

6. Good Documentation Practices
Why GDP is Important…
 Similarly…… GDP is important
To express yourself, your activity to other who read it like your customer or
auditor.
To allow them to have correct impression
regarding your work and you.
To allow them to have assurance on your job

7. Good Documentation Practices
Why GDP is Important…
 An essential part of the quality assurance system and should exist for
all aspects of GMP (reference: WHO GMP, Volume 2)
 Good documentation practice is an ‘obvious’ ‘expected’ ‘practice’…!
 Correct, complete, current, and consistent information effectively
meets customer and stakeholder' requirements
 Helps to reduce observations raised on “inadequate” documentation
practices

8. Good Documentation Practices
What constitutes Good Documentation?
 Approval, review and updation of documents
 Changes & current revision status of documents identified
 Relevant versions of applicable documents available at points of use
 Documents remain legible and readily identifiable
 Documents of external origin identified, and their distribution controlled
 Prevent unintended use of obsolete documents, and archiving

9. Good Documentation Practices
Observations on poor documentation practices…
 Document error correction not signed/dated, and didn’t include a reason for the
correction
 Write-overs, multiple line-through and use of "White-out" or other masking device
 Sample sequence table and audit trail not documented (if its not documented, it
didn’t happen)
 SOP related to production, calibration, storage and maintenance not authorized by
the QA head
 The delegation for the batch release, in case of absence of the QA manager, not
recorded / documented
 Out-of-specification (OOS) procedure not detailed enough; flow chart and /or
check-list not available

10. Good Documentation Practices
Common Documentation Errors…

11. Good Documentation Practices
Some more examples…

12. Good Documentation Practices
Some more examples…

13. Good Documentation Practices
Some more examples…

14. Good Documentation Practices
Some more examples…

15. Good Documentation Practices
Some more examples…

16. Good Documentation Practices
What we need to know…
 Forms of Data,
 Paper forms, data sheets, and worksheets
 Notebooks and logbooks
 Instrument printouts
 Electronic data obtained with a system such as an electronic data system, laboratory
information management system (LIMS), or electronic laboratory notebook (ELN)
 Categories of documents:
 Laboratory Records/Procedures
 Equipment-Related
 QMS Documents
 Batch Records
 Training

17. Good Documentation Practices
What we need to know…
 Types of Documents,
 Specifications: basis for quality evaluation
 Standard Operating Procedures: gives directions for performing certain operations
 Batch Manufacturing Records (BMR): gives manufacturing formula and
processing instructions
 Batch Packing Records (BPR): gives details of the packing materials and packing
instructions
 Forms for recording data: used to execute the data of evidence
 Protocols: describes the details of a comprehensive planned study to investigate the
consistent operation of new system/equipment, a new procedure, or the acceptability
of a new process before it is implemented
 Quality System Documents: Change Control, Deviations, Incidents, OOS, OOL,
CAPA

18. Good Documentation Practices
What we need to know…
 ALCOA & ALCOA+
 A- Attributable: Who did what..
 L- Legible: One can read what is written
 C- Contemporaneous: at the time of occurrence
 O- Original: as obtained and written
 A- Accurate: must be error free
 + Complete: No missing
 + Consistent: Uniform / Sequence
 + Enduring: Long Lasting
 + Available: ready to refer
We have written procedure to follow: SOP/QAD/GEN/006

19. Good Documentation Practices
Principles Of Good Documentation… USP <1029>
 Records should be clear, concise, accurate, and legible.
 Data entries should be recorded promptly when actions are performed. Backdating and postdating are not allowed.
 All corrections to the original entries should be initialed and dated (or captured within an electronic audit trail), with an
explanation included in cases where the reason for the change is not obvious.
 Data entries should be traceable to the person who made the entry. Notebooks, data sheets, and worksheets should be
traceable.
 Uncommon abbreviations and acronyms should be defined.
 If ink may have faded over time (e.g., thermal paper), a copy can be used with verification of its accuracy.
 An adequate documentation system is needed to ensure data integrity and availability of current and archived records.
 Controls should be in place to protect the integrity of the records.
 Records should be retained per regulatory requirements and be readable during the retention period.
 All pages should be paginated. Attachments (supporting documents) should be paginated with a reference to the parent
document.

20. Good Documentation Practices
What we need to know…
 Document Should,
 Be Designed, Prepared, Reviewed, Approved/Authorized, Distributed, And Archived “with care”
 Comply with the relevant parts of the manufacturing and marketing authorization dossiers.
 have unambiguous contents; Title, Nature and purpose should be clearly stated
 Be laid out in an orderly fashion and be easy to check.
 be regularly reviewed and kept up-to-date.
 Should prevent inadvertent use of superseded documents.
 Be provided with sufficient space for entries
 be made or completed at the time each action is taken
 Be 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

21. Good Documentation Practices
What we need to know…
 Review is important
 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

22. Good Documentation Practices
Some tips on Good Documentation Practices
 Do’s
 Records should be completed at time of activity or when any action is taken
 Superseded documents should be retained for a specific period
 Records should be retained for at least one year after the expiry date of the finished product
 Concise, legible, accurate and traceable
 Picture is worth a thousand words
 Clear examples
 Don’ts
 Enter data when activity has not been completed
 Sign for work prior to that work being performed
 Sign for another person’s work with your name
 Use other than today’s date
 Change original / non-retrievable data without supporting documentation
 Document verification of data without individual observation
 Don’t assume knowledge

23. Good Documentation Practices
Must-to-have…
Errors or mistakes are possible – person recording is human
But
Practices Makes Perfect
Frequently doing something makes one better at doing it

24. Good Documentation Practices
Must-to-have…
 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

25. Good Documentation Practices
Must-to-have…
 Implementation through…
 Swear to record the actual information/ data
 Be honest
 Strengthen the review
 Report the deviation
 Train subordinates on common /identified mistakes or errors

26. Good Documentation Practices
Must-to-have…
Good documentation structure provides an assurance of the quality
of product
Documentation can be viewed as the foundation of all quality
systems
Practice puts brains in your muscles

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