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Good Documentation Practices

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18 views35 pages

Good Documentation Practices

Uploaded by

kowshik.qa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Good Documentation Practices

Objective

To describe fundamental requirements of


Good Documentation Practices
Why Document?

Documents provide written proof


that something happened.
Why Document?

Documents are the only official (legal) proof of:


• processing a batch
• final decision to release (or reject) a batch or
product
• evidence for a corrective or preventive action
(CAPA)
• an investigation of deviations, complaints etc.
• meeting product quality specifications
Why Document?

Records and reports (Documents),


along with procedures, "tell the
story" of manufactured products
Documents Hierarchy
Why Document?

• For business reasons, maintaining accurate


records is also important.

• By maintaining clear, accurate and timely records


we can take a critical look at various processes
related to product manufacture with the intent of
making quality, product or cost saving
improvements.
Why Document?

GDPs apply to everyone


who documents activities
related to cGMP Practices.

GDPs are enforced by regulatory agencies such as the


FDA, TGA, EMEA, Health Canada or WHO.
Why Document?

GDPs are enforced by regulatory agencies such as the


FDA, TGA, EMEA, Health Canada or WHO.
What are Good Documentation Practices?

Good Documentation Practices (GDPs), are the


guidelines that one follows in recording raw data entries
in a legible, traceable and reproducible manner.

A key to Good Documentation Practices is to consider


these questions each time record of raw data:

1. Is it true? 2. Is it accurate?
3. Is it timely? 4. Is it legible?
Types of documents require following GDPs

Some Examples –
• Analytical Methods
• Batch Records • Standard Operating
• Certificate of Analyses (CoA) Procedures
• Laboratory Notebooks • Test Methods
• Logbooks • Training
• Policies Documentation
• Protocols • Validation Documents
• Quality records o non- (IQs, OQs and PQs)
conformances • Work Instructions
• CAPAs • Product and Sample
• internal inspection reports Labels
• change control
Categories of Documents

1. Primary records –
 Master formula,
 Manufacturing and packaging instructions.

2. Supporting procedures
 instructions on how to perform a manufacturing step or
test methodology.
Categories of Documents

3. Subsidiary records which support the process as it is


being carried out.
 environmental monitoring or
 preventive maintenance/calibration on process or
lab equipment.

4.Quality control records


 lab testing results for the process or products and
 all investigative reports and records
The Meaning of Signature

Signing of a GMP document –


 Confirm one’s unique identity.
 State that someone has the authorization to perform,
verify, check, review or approve the activity associated
with his/her name.
 Recognize that someone’s signature and initials cannot
be taken back; once signed, he/she is personally,
professionally and legally responsible for the action
taken.
Controlling Signature

 It is imperative that strict control should be maintained over


the use of your signature and initials.

 Sign and initial only for yourself.

 Never allow someone else to sign or initial for you unless


that person is authorized in writing to do so and according to
procedure.
Controlling Signature
Signature Log or Signature Logbook

 Everyone who signs controlled documentation must register


their signature and initials.

 This allows identification of a person performing or


supervising a specific GMP activity.

 This registration includes all temporary and contract


employees.
Signature Log or Signature Logbook

 Remember,
 we must always sign or initial documents exactly as we
have entered our signature and initials in the signature
log book.
 Signature log should be routinely reviewed to verify the
accuracy of the signature.
Documentation Control

Retention and Disposal of


Quality Records
Ref. Doc. No. : SOP/CPU-QA/018
Ver. No. : 08

21
Document Life Cycle
Data Integrity
Data Integrity
ALCOA
Attributable

• Who performed an action and when?


• If a record is changed, who did it and why?
• Link to the source data.
Legible

• Document must be recorded permanently and be


readable.
Contemporaneous

• Document should be recorded at the time the


work is performed and date/time stamps should
follow in order.
Original

• Is the information the original record or a certified


true copy?
Accurate

• No errors or editing performed without


documented amendments.
ALCOA Plus

Complete
Consistent
Available
GMP Deficiency
References

• WHO Technical Report Series No. 986, Annex 2, 2014, WHO


Good Manufacturing Practices for Pharmaceutical Products:
Main Principles-Chapter 15: Documentation.

• WHO Technical Report Series No. 996, Annex 5, Guidance on


Good Data and Record Management Practices.
References

• EudraLex The Rules Governing Medicinal Products in the


European Union, Volume 4, EU Guidelines to Good
Manufacturing Practice Medicinal Products for Human and
Veterinary Use, Brussels, 30 June 2011 – Chapter 4:
Documentation.

• EU GMP Guide Part I Chapter 4 Documentation, Rules and


Guidance for Pharmaceutical Manufacturers and Distributors,
2017, MHRA.
References
Q&A
37

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