Transcript good documentation practice

GOOD DOCUMENTATION PRACTICES
(GDP)
PRESENTED BY:
SATYAVAN SINGH
GENERAL MANAGER QUALITY
INTAS PHARMACEUTICALS LIMITED
SIKKIM
General Principle of Documentations
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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
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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
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Document
• An approved instruction either in paper or electronic
form which guides about how an activity shall be
executed.
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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.
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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• Superseded documents should be retained for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 &
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
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:
“IF
YOU HAVE NOT
DOCUMENTED AN
ACTIVITY,
YOU HAVE NOT