GOOD DOCUMENTATION PRACTICES

(GDP)

PRESENTED BY:
SATYAVAN SINGH
GENERAL MANAGER QUALITY
INTAS PHARMACEUTICALS LIMITED
SIKKIM
 General Principle of Documentations

• Design (correct, complete, current & traceable)

• Prepared
• Reviewed
• Proper Distribution
 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.
 Different types of documents

• Batch records • Calibration Records

• Specifications • Standard procedure
• Validation & • Room Temperature/ %RH
Qualification Records Records
• Stability Study Summary
Report
• Machine Logs
• Product and sample
labels
• Analytical Methods
• Manufacturing
Procedures
 Characteristics of Good Documents

– ACCURATE
– AUTHENTIC
– CLEAR
– COMPLETE
– CURRENT VERSION
– LEGIBLE
– PERMANENT
 Some Guidance Documents

• Schedule M of Drug And Cosmetics Act 1940

• ISO - 9001 : 2008

• US FDA CFR sections

– 21 CFR 11, 210 & 211
Schedule M

7
 ISO – 9001 :2008

Section 4: Quality Management System

4.2.2 Control of Documents

4.2.3 Control of Records

8
 Document

• An approved instruction either in paper or electronic form

which guides about how an activity shall be executed.

9
 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.

10
 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.

11
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.
 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• Superseded documents should be retained for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.

 Typical Retention Time
Type of Documents Minimum Retention Period
Batch related Records (Executed Documents & 1 year beyond expiry date whichever is
Analytical Report- Chemical & Microbiology) longer.

Legal Documents (Mfg. Lic.,Regulatory Approvals, for posterity

Certificates)
Master Documents and Supersedes and Obsolete Copy of Master document

SOP (Standard Operating Procedures) 5 years from the Obsolete Date

Standard Test Procedures (STP), 5 years from the Obsolete Date

Site Master File For Posterity (Current version)

Master Formula Card & QFR, BMR& BPR 5 years from the obsolete Date

Stability Study Protocol & Reports For Posterity

 A Famous Proverb says:

“IFYOU HAVE NOT

DOCUMENTED AN
ACTIVITY,
YOU HAVE NOT DONE
IT”.
 K Y OU
THAN