Tiêu chuẩn GMP WHO: Hồ sơ và tài liệu (phần 1). Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU.

1. Basic Principles of GMP
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Module12–part1 Slide1of 20 2012
Documentation
Part 1
15

2. Documentation
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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. 15.1
Documentation
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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. 15.1
Documentation
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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. What is being
made?
Most of us when
attempting a task
need some sort of
documentation
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Documentation

6. And if the drawing is wrong!
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Documentation

7. Documentation
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8. Why are documents so important?
 Communication
 Cost
 Audit trail
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Documentation

9. 15.2
Documentation
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General Principles – I
 Documents should be
 designed
 prepared
 reviewed
 distributed with care
 Comply with marketing authorization
 Design of documentation important

10. 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
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approval – change control
Documentation
15.3

11. 15.4
Documentation
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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. 15.5
Documentation
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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. 15.6 – 15.8
Documentation
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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. 15.9
Documentation
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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. 15.9
Documentation
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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. Documentation
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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. Documentation
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18. Documentation
 Photographs can
be documents and
part of a herbal
identification,
provided they are
properly authorized
and controlled
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19. Documentation
 Flow charts provide substantial information at a glance
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20. Documentation
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Types of Documentation
 The different types of documents will be discussed in
detail in Documentation: Part 2