Good documentation practice Introduction What types of documents require to follow Good Documentation Practices? Meaning of signature Purpose of documentation Basic requirements of GDP Preparation of documents Cancellation of GMP records reference • Analytical Methods • Policies • Batch Records • Protocols • Bills of Materials (BOMs) • Test Methods • Certificate of Analyses (CoA) • Training Documentation • Certificate of Compliance (CoC) • Logbooks • Laboratory Notebooks • Calibration records • Quality records - non-conformances - CAPAs - internal inspection reports - change control

1. Vasundhara
Mpharm
1

2. content
 Introduction
 What types of documents require to follow Good
Documentation Practices?
 Meaning of signature
 Purpose of documentation
 Basic requirements of GDP
 Preparation of documents
 Cancellation of GMP records
 reference
2

3. Introduction
 The GDP can be defined as “Good documentation practice is an
essential part of the quality assurance and such, related to all
aspects of GMP” this definition is based on WHO.
 GDPs apply to everyone who documents activities related to
cGMP or current Good Manufacturing Practices.
 A key to Good Documentation Practices is to consider these
questions each time you record your raw data:
1. Is it true?
2. Is it accurate?
3. Is it timely?
4. Is it legible?
3

4. What types of documents require to follow Good
Documentation Practices?
 Some examples include:
• Analytical Methods
• Policies
• Batch Records
• Protocols
• Bills of Materials (BOMs)
• Test Methods
• Certificate of Analyses (CoA)
• Training
4

5. Cont…
Documentation
• Certificate of Compliance (CoC)
• Logbooks
• Laboratory Notebooks
• Calibration records
• Quality records - non-conformances
- CAPAs
- internal inspection reports
- change control
5

6. Cont….
• Standard Operating Procedures
• Validation Documents (IQs, OQs and PQs)
• Work Instructions
• Product and Sample Labels
6

7. The Meaning of Signature
 Generally speaking, when signing your name to a GMP
document, you:
1. Confirm your unique identity.
2. State that you have the authorization to perform, verify,
check, review or approve the activity associated with your
name.
3. Recognize that your signature and initials cannot be
taken back; once signed, you are personally, professionally
and legally responsible for the action taken.
7

8. Purpose of Documentations
• 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
• Ensures documented evidence, traceability, provide
records and audit trail for investigation
• Ensures availability of data for validation, review and
statistical analysis.
8

9. Basic requirements of GDP
 Always record the entries at the time of activity simultaneously.
 Always record the date with the signature in GMP records.
 Always enter the data directly into the GMP records in the
English language.
 Never use whitener or eraser to re correct the sentence, just
strike off the sentence with simple line and write the correct
sentence with sign & date.
 Never sign for someone else on any document. Only sign for the
work that you have performed yourself.
 Never backdate GMP records.
 Documentation and records used throughout the
manufacturing process,as well as supporting
processes,must meet the basic requirement of GDP.
9

10. Preparation of documents
 Clear and concise titles should be used for headings, tables,
graphs, etc..
 Pages in master document should be numbered as X of Y.
 All documents should have the signature and date of the
person who prepared the document, reviewed & approved
the document.
 All documents should have effective date, approval date,
revision no. & supersede no.
 Respective SOPs should be followed while preparing the
documents. When creating a document, consider the
context in which the document may be used in future and
reader has enough background information.
10

11. Cont……
 Training of the document should be planned only after
approval of the document and shall be completed
before the effective date.
 Time should enter in documents in 24:00 hrs cycle.
 Entries in log book should be made in chronological
order. entries should never be pre-completed.
 Data should be recorded by trained& authorised
person only.
 Manual entries should be reviewed and singed by the
second person for accuracy & completeness.
11

12. Cancellation of GMP records
 Cancellation of GMP records should only be allowed in
the rare case with the approval of QA and in
exceptional cases such as spillage of chemical on the
record. Event investigation should be followed to
determine further course of action. the reason for
cancellation should be documented for cancellation of
the document and signed by area person-in-charge
and QA.
12

13. Refrence
 cGMP-Meeting-Series-021215.pdf
 PHARMATUTOR-ART-1288
13

14. thank you
13
14