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GMP Documentation

  1. 1. 1 GDP
  2. 2. cGMP DOCUMENTATION REQUIREMENTS (Good Documentation Practices) 2
  3. 3. Document….? The document is information (meaningful data) and its supporting medium, which could be.. In paper form, CD, Computer Files, Or Microfilm. 3 DOCUMENTATION
  4. 4. Documentation..? is the key to GMP compliance and ensures traceability of all…  development, manufacturing and testing activities. provides the route for auditors to assess the overall quality of operations within a company and the final product. 4 DOCUMENTATION
  5. 5. Documentation..? provides the route for auditors to assess the overall quality of operations within a company and the final product. 5 DOCUMENTATION
  6. 6. Good Documentation..? An essential part of the quality assurance system. Clearly written procedures prevent errors resulting from spoken communication 6 DOCUMENTATION
  7. 7. Inclusions Of Documentation !!! The following documents (not limited to it): Records Labels Specifications And Testing Procedures Master Formulae Packaging Instructions Batch Manufacturing Records (BMR) Batch Packaging Records (BPR) Standard Operating Procedures (SOPs) 7 DOCUMENTATION
  8. 8. Maintenance of Documents: Documents, as required under local rules*, shall be meticulously (Thoroughly) maintained regularly reviewed kept up-to-date, (i.e. Document Control System). * Drugs Rules -1976- Schedule B-II Part I 8 DOCUMENTATION
  9. 9. Records of Action:  traceable. Batch Records : shall be retained for at least…five year after the expiry date. 9 DOCUMENTATION
  10. 10. Documentation Systems: Data may be recorded by … Electronic data processing systems or By photographic or Other reliable means.  be Available and The accuracy of the records shall be checked. 10 DOCUMENTATION
  11. 11. Only authorized persons shall be able to enter or modify data in the computer, Maintain a record of changes and deletion; Access shall be restricted by; Passwords or other means The entry of critical data shall be independently checked. Data shall also be readily available. 11 DOCUMENTATION
  12. 12. Status Identification:….. Labels applied to… containers, equipment, or premises shall be…… Unambiguous (clear) and In the Company’s Agreed Format. Ambiguous Documents 12 DOCUMENTATION
  13. 13. Status Identification: The labels of different colors to indicate the status such as; “Quarantined - Yellow”, “Accepted - Green”, “Rejected - Red”, may also be used in addition to the wording. 13 DOCUMENTATION
  14. 14. 14 • Name of product • Ingredients • Net Content • Batch number • Expiry date • Storage condition • Information about manufacturing company (Lice. No. and Address) Finished Product Labeling: Shall be labeled in accordance with the Drug (Labeling and Packing) Rules 1986. DOCUMENTATION
  15. 15. Reference Standard Identification: (for QC Lab) For reference standards, the label or accompanying documents shall indicate; 15 DOCUMENTATION • Name of material • Purity/ Potency • Date of manufacture • Batch number • Shelf-life/ Expiry Date • Storage condition
  16. 16. Specification approvals: Specifications should be available for : Each specifications shall be; Approved and, Maintained by the quality Assurance. 16 DOCUMENTATION • Raw Materials • Finished Products (Bulk & Intermediate Product) • Packaging Materials Bulk & Intermediate Product
  17. 17. Revision of Specification: Periodic revisions to comply with…. new edition of the National Pharmacopoeia or other Official Compendia or the Drugs (Specifications) Rules 1978. 17 DOCUMENTATION USP BP DR
  18. 18. Batch Processing Records: During processing, the following information shall be; 18 DOCUMENTATION • A batch Processing Record shall be kept for each batch, • Transcription Errors
  19. 19. Checking Work Station: Before any processing begins, 19 DOCUMENTATION • A check for previous Products, • Documents or Materials not required for the planned process, •Equipment is clean and suitable for use, •Check shall be recorded
  20. 20. Recording Process Operation: During processing, the following information shall be; 20 DOCUMENTATION • Time of action taken • Signed by responsible for Operation Completed • Name of Product • Batch No. •Date and time of commencement of significant stages of production
  21. 21. 21 DOCUMENTATION •The name of the person responsible for each stage • The initials of the operator(s) of different significant steps of production • Person(s) who checked each of these operations (e.g. weighing); Recording Process Operation: Continued…
  22. 22. 22 DOCUMENTATION • The batch number and /or analytical control number • The quantity of each starting material actually weighed including the… • Batch/Lot number and • Amount of any recovered or reprocessed material added; Recording Process Operation: Continued…
  23. 23. 23 DOCUMENTATION • any relevant processing operation or event, • the major equipment used; • the in-process controls performed, • the initials of the person(s) involved, • and the result obtained; Recording Process Operation: Continued…
  24. 24. 24 DOCUMENTATION • Yield together with comments or explanations for significant deviations from the expected yield; and • notes on special problems including details, with signed authorization for any deviation from the master formula. Recording Process Operation: Continued…
  25. 25. Pre-packaging Line Check: 25 DOCUMENTATION • A batch packaging record shall be kept • to avoid transcription errors. Batch Packaging Records: • A batch packaging record shall be kept
  26. 26. 26 DOCUMENTATION • by Name and signature. • the name of the product, • the batch number, • the quantity of bulk product • the batch number and the planned quantity of finished product obtained, • the quantity actually obtained, • the reconciliation; Recording of Packaging Operation:
  27. 27. 27 DOCUMENTATION • the date(s) and time(s) of the packaging operations, • the name of the responsible person, • batch number, • the checks for identity & conformity, including the results of in-process controls; Recording of Packaging Operation: : Continued…
  28. 28. Details of the packaging operations carried out, including… 28 DOCUMENTATION • references to equipment, • the packaging lines used, • samples of the printed packaging materials used, • expiry date, & • any additional overprinting; Recording of Packaging Operation: : Continued…
  29. 29. The quantities and reference number , Identification of all printed packaging materials Bulk product issued, Used, destroyed, or returned to stock and … The quantities of product obtained to permit an adequate reconciliation. 29 DOCUMENTATION
  30. 30. the initials of the persons who performed the testing; the initials of the persons who verified…  the testing and  the calculations, where appropriate; and A clear statement of Release or Rejection (or other status decision) dated signature of the designated person. 30 DOCUMENTATION RELEASED
  31. 31. Recording Batch Numbers: Batch-number shall be recorded  in a Logbook,  with product… Logbook  identity, and size of batch. 31 DOCUMENTATION
  32. 32. Recording Batch Numbers: In addition to the batch number, references of the relevant specifications and testing procedures; test results, including… observations calculations, dates of testing; 32 DOCUMENTATION
  33. 33. Equipment Logbooks: Logbooks shall be kept with equipment and record, as appropriate, any…  validations, calibrations, maintenance, Logbook cleaning, or repair operations including dates and the identity of the person who carried out these operations. 33 DOCUMENTATION
  34. 34. Equipment Utilization Record: Use of major and critical equipment, areas, Where products have been processed…. shall be … recorded in Chronological order (In Sequence). 34 DOCUMENTATION
  35. 35. Reasons for GMP Documentation Requirements 1) Practice Good Business Sense 2) Fulfill Regulatory Requirements 3) Prevent Mix-ups and Errors DOCUMENTATION
  36. 36. Documentation Key Characteristics To ensure GMP Compliance, all documents must be:  accurate  complete & verified  clear  reliable  legible  retrievable  permanent  current
  37. 37. Principles for Good Documentation Reviewers of documents/records must be  sufficiently trained. All errors detected during record review must be immediately  Corrected  Documented DOCUMENTATION
  38. 38. Documents preparation, review, and approval processes must be  defined by operating procedure(s). Documents must be ….  periodically audited. Principles for Good Documentation DOCUMENTATION
  40. 40. Basics: Always keep the document concurrent with process recording information and signing immediately after the step is performed. signatures / initials should…  be legible,  recorded in the correct blanks,  Use a permanent ink. For example; Black or Dark Blue Permanent Ink is strongly encouraged. DOCUMENTATION
  41. 41. Do not use downward arrow (), “ditto marks”, or “squiggle s”, to record repeated data in a column _______ _________ _________ ________ __________ ___________ ________ __________ ___________ _________ __________ ___________ ________ __________ ___________ JWC 20-Dec-2012 JWC 20-Dec-2012 JWC 20-Dec-2012 DOCUMENTATION
  42. 42. Write and record information neatly to make the document legible Keep document clean by not placing random marks on it Document cross-outs and write-overs of digits or characters correctly, by writing your initials & date of the correction near the cross out Incorrect: 187 187 • Do not try to remove all traces of Correction 187 Never use correction ink, correction tape or erasable pens 189 JWC 20-Dec-2012 DOCUMENTATION
  43. 43. Example 1 4 7 5 Example 2 4 5 Number should be crossed-out with one line, initialed and dated. Unclear what the number is. All corrections should be made the same way. 475 485 JWC 20-Dec-2012 7 DOCUMENTATION
  44. 44.  Measurements: Ensure that all records include units of measurement for …. • volume, • weight, • pressure etc. Examples: 3.56 kg / 300 mL DOCUMENTATION
  45. 45. 1) Follow the organization’s accepted format for recording dates .. i.e. dd-mm-yy (04-12-2013) is standard format Don’t Use mm-dd-yy (12-04-2013) etc. 2) Be consistent… • across your organization • in your own work DOCUMENTATION
  46. 46.  Time: be complete and indicate which part of the day the operation took place i.e. 10:08 am or 10:08 pm  follow the organization’s accepted practice for recording time format i.e. 10:08 am or pm DOCUMENTATION
  47. 47. Recording Data and Calculations:  Ensure that… • the decimal points are in the correct position. • the digits in numbers have not been reversed. • the number of significant digits is correct. DOCUMENTATION
  48. 48. Protect the document from • spills • excess folding • other physical damage • random marks A Little Documentation Respect DOCUMENTATION
  49. 49. 49 THANKS