1. GOOD DOCUMENTATION PRACTICES (GDP)
PRESENTED BY:
SATYAVAN SINGH
GENERAL MANAGER QUALITY
INTAS PHARMACEUTICALS LIMITED
SIKKIM

2. General Principle of Documentations
Design (correct, complete, current & traceable)
Prepared
Reviewed
Proper Distribution

3. Why GDP ?
Good documentation practices (GDP) is required in order to ensure an auditable account of work performed.
GDP is required for all documentations included in a fully developed quality system.

4. Different types of documents
Batch records
Specifications
Validation & Qualification Records
Calibration Records
Standard procedure
Room Temperature/ %RH Records
Stability Study Summary Report
Machine Logs
Product and sample labels
Analytical Methods
Manufacturing Procedures

5. Characteristics of Good Documents
ACCURATE
AUTHENTIC
CLEAR
COMPLETE
CURRENT VERSION
LEGIBLE
PERMANENT

6. Some Guidance Documents
Schedule M of Drug And Cosmetics Act 1940
ISO : 2008
US FDA CFR sections
21 CFR 11, 210 & 211

7. Schedule M

8. ISO – 9001 :2008 Section 4: Quality Management System
4.2.2 Control of Documents
4.2.3 Control of Records

9. Document
An approved instruction either in paper or electronic form which guides about how an activity shall be executed.

10. Record A record is often considered as document.
Records provide evidence that activities have been performed or results have been achieved.
They always document the past.

11. Document Vs Record
A document can be a procedure, specification, drawing, work instruction and the record is also a document with the difference that it provides evidence of compliance with established requirements and effectiveness of the operation of QMS.

12. How are mistakes corrected?
Draw a single line through the error
Make the correction next to the error
Write an explanation for the error
Sign and date the correction.

13. Some tips on GDP Records should be filled online.
Superseded documents should be retained for a specific period of time.
Records should be retained for at least one year after the expiry date of the finished product.
Concise, legible, accurate and traceable.

14. Typical Retention Time
Type of Documents
Minimum Retention Period
Batch related Records (Executed Documents & Analytical Report- Chemical & Microbiology)
1 year beyond expiry date whichever is longer.
Legal Documents (Mfg. Lic.,Regulatory Approvals, Certificates)
for posterity
Master Documents and Supersedes and Obsolete Copy of Master document
SOP (Standard Operating Procedures)
5 years from the Obsolete Date
Standard Test Procedures (STP),
Site Master File
Master Formula Card & QFR, BMR& BPR
For Posterity (Current version)
5 years from the obsolete Date
Stability Study Protocol & Reports
For Posterity

15. DOCUMENTED AN ACTIVITY,
A Famous Proverb says:
“IF YOU HAVE NOT
DOCUMENTED AN ACTIVITY,
YOU HAVE NOT DONE IT”.

16. THANK YOU