This document discusses the basic principles of documentation in Good Manufacturing Practices (GMP). It outlines general documentation principles such as documentation defining specifications and procedures, ensuring all personnel know what to do, and providing an audit trail. Specific requirements covered include documents being designed, prepared, reviewed and distributed with care, complying with marketing authorization, and being approved, signed and dated. The document also discusses general principles for data entry, storage, and retention in documentation.

1. Module 12 – part 1 | Slide 1 of 20 2012
Basic Principles of GMP
Documentation
Part 1
15

2. Module 12 – part 1 | Slide 2 of 20 2012
Documentation
Objectives
1. To review general requirements for documents
2. To review specific requirements for each document
3. To consider current issues applicable to your countries

3. Module 12 – part 1 | Slide 3 of 20 2012
15.1
Documentation
General Principles – I
 Good documentation is an essential part of the QA system
 Should exist for all aspects of GMP
 Purpose of documentation
 Defines specifications and procedures for all materials and
methods of manufacture and control
 Ensures all personnel know what to do and when to do it
 Ensure that authorized persons have all information
necessary for release of product

4. Module 12 – part 1 | Slide 4 of 20 2012
15.1
Documentation
General Principles – I
 Purpose of documentation (cont.)
 Ensures documented evidence, traceability, provide records
and audit trail for investigation
 Ensures availability of data for validation, review and
statistical analysis
 Design and use
 Depends upon manufacturer
 Some documents combined into one, sometimes separate

5. Module 12 – part 1 | Slide 5 of 20 2012
What is being
made?
Most of us when
attempting a task
need some sort of
documentation
Documentation

6. Module 12 – part 1 | Slide 6 of 20 2012
And if the drawing is wrong!
Documentation

7. Module 12 – part 1 | Slide 7 of 20 2012
Documentation

8. Module 12 – part 1 | Slide 8 of 20 2012
Why are documents so important?
 Communication
 Cost
 Audit trail
Documentation

9. Module 12 – part 1 | Slide 9 of 20 2012
15.2
Documentation
General Principles – I
 Documents should be
 designed
 prepared
 reviewed
 distributed with care
 Comply with marketing authorization
 Design of documentation important

10. Module 12 – part 1 | Slide 10 of 20 2012
General Principles – II
 Look at the “Style” of the document
 Instructions in the imperative
 Short sentences preferred to long sentences
 Approval of documentation
 Approved, signed and dated by appropriate responsible
persons
 No document should be changed without authorization and
approval – change control
Documentation
15.3

11. Module 12 – part 1 | Slide 11 of 20 2012
15.4
Documentation
General Principles – III
 Contents of documents should be clear (easy to understand)
and include, e.g.
 Title, nature, objective or purpose
 Layout in orderly fashion
 Easy to be filled in and checked
 Clear and readable – (also copies if these are made)
 No errors if master documents are copied for working
documents

12. Module 12 – part 1 | Slide 12 of 20 2012
15.5
Documentation
General Principles – IV
Documentation control
 Regular review of documents
 Kept up to date (current) – amended – through change control
 Superseded documents removed and not used
 Distribution and retrieval of documentation
 Retention time for superseded documents

13. Module 12 – part 1 | Slide 13 of 20 2012
15.6 – 15.8
Documentation
General Principles – V
Data entry
 Clear, readable and indelible
 Design to allow for sufficient space for entries
 Changes to entries:
 signed, dated and reason given
 original entry still readable
 Entries at the time of action
 All significant actions recorded – traceable

14. Module 12 – part 1 | Slide 14 of 20 2012
15.9
Documentation
General Principles – VI
Data entry (cont.)
 Electronic data processing systems, photographic systems or
other reliable means
 Systems require SOPs and records
 Accuracy of records checked
 Authorized persons - access and changes
 Password controlled
 Entries checked

15. Module 12 – part 1 | Slide 15 of 20 2012
15.9
Documentation
General Principles – VII
Data entry (cont.)
 Batch records stored electronically:
 Protected
 Back-up transfer, e.g. magnetic tape, microfilm,
paper print-outs
 Records kept 1 year after expiry date of product
 Data readily available during retention period

16. Module 12 – part 1 | Slide 16 of 20 2012
Documentation
Types of Documentation
 Labels
 Specifications and testing procedures
 Master formulae and instructions
 Batch processing and batch packaging records
 Standard Operating Procedures (SOPs)
 Records
 Stock control and distribution records
 Other documents …

17. Module 12 – part 1 | Slide 17 of 20 2012
Documentation

18. Module 12 – part 1 | Slide 18 of 20 2012
Documentation
 Photographs can
be documents and
part of a herbal
identification,
provided they are
properly authorized
and controlled

19. Module 12 – part 1 | Slide 19 of 20 2012
Documentation
 Flow charts provide substantial information at a glance

20. Module 12 – part 1 | Slide 20 of 20 2012
Documentation
Types of Documentation
 The different types of documents will be discussed in
detail in Documentation: Part 2