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GOOD DOCUMENTATION PRACTICES (GDP)

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 ?.

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GOOD DOCUMENTATION PRACTICES (GDP)

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  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 - 9001 : 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 • Superseded documents should be retained for a specific period of time.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

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

  16. THANK YOU

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