GOOD DOCUMENTATION PRACTICES GOOD DOCUMENTATION PRACTICES (GDP)(GDP)

PRESENTED BY:SATYAVAN SINGHGENERAL MANAGER QUALITYINTAS PHARMACEUTICALS LIMITEDSIKKIM

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• 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

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

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Schedule M

8

ISO – 9001 :2008

Section 4: Quality Management System

4.2.2 Control of Documents

4.2.3 Control of Records

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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.

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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.

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• Superseded documents should be retained for a specific period of time.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.

Type of Documents Minimum Retention PeriodBatch 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), 5 years from the Obsolete Date

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

Typical Retention Time

A Famous Proverb says:

“IF YOU HAVE NOT DOCUMENTED AN

ACTIVITY, YOU HAVE NOT

DONE IT”.

THANK YOU