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GOOD DOCUMENTATION PRACTICES GOOD DOCUMENTATION PRACTICES (GDP)(GDP)
PRESENTED BY:SATYAVAN SINGHGENERAL MANAGER QUALITYINTAS PHARMACEUTICALS LIMITEDSIKKIM
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General Principle of Documentations
• Design (correct, complete, current & traceable)
• Prepared• Reviewed• Proper Distribution
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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.
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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
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Characteristics of Good Documents
– ACCURATE– AUTHENTIC – CLEAR– COMPLETE – CURRENT VERSION– LEGIBLE– PERMANENT
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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
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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.
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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.
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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
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A Famous Proverb says:
“IF YOU HAVE NOT DOCUMENTED AN
ACTIVITY, YOU HAVE NOT
DONE IT”.
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THANK YOU