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Bholakant Raut

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This slide is specially prepared for In-House GLP training program for Quality Control Department covering Good Documentation Practice topic.....

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Bholakant Raut

  1. 1. Phr. Bholakant raut Quality Control Officer Bachelor in Pharmacy, NPC Regd. No: G 1997 TIME Pharmaceuticals (P.) Ltd. Good Documentation Practice (GDP)
  2. 2.  Introduction  The purposes of Good Documentation (QC Laboratory)  Key features of good documentation  Why good documentation is essential?  Types of Documentation (forms)  Documentation Pyramid What constitutes Good Documentation? (GDP)  Common Documentation Errors  Benefits of good documentation  Conclusion 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 2
  3. 3. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 3 The document is information (meaningful data) and its supporting medium, which could be in paper form, CD, computer files, or microfilm. Document provides information or evidence or may serve as an official record. Documentation is an integral component of GMP and the quality management system. It is also key to GMP compliance for it ensures traceability of all development, manufacturing, and testing activities.
  4. 4. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. Documentation is a professional skill, as important as other skills Can make you look professional or unprofessional….you decide 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 4
  5. 5. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 5 To define the specifications and procedures (SOPs) for the analysis of excipients, active ingredients, products and handling of equipments and machines. To ensure that all personnel concerned with quality control tests know what to do and when to do it. To ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation. And to ensure the availability of the data needed for validation, review, and statistical analysis.
  6. 6. Legible: Everyone should be able to read what is written regardless of who, where or what has been written. Concise: The document must provide clear information that is understood by all officers. Traceable: who recorded it, where, when and why ? Accurate: Documentation should be error-free―properly reviewed, verified and approved. Contemporaneous: The information should be documented at the correct time frame along with flow of events. Enduring: Long lasting and durable. Accessible: Easily available for review. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 6
  7. 7. In a GMP environment documentation needs to meet certain requirements to ensure product quality and product safety. If an instruction or record is poorly documented, then the manufacture or Quality assurance/control of a product can be negatively impacted, potentially reducing patient safety. “GDP describes the standards by which documentation is Created and Maintained in the pharmaceutical industry” 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 7
  8. 8. The GMP regulations include mandatory sections on documentation. Documentation provides both: Information on when, where, who, why and how to complete tasks, and Evidence proving that the tasks have been completed as they should be. Consequently, the standard of documentation within a company can directly impact the level of success in manufacturing quality products that are safe as well as success during audit situations. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 8
  9. 9. A. Documents – procedural or instructional documentation Examples are: Training schedules, change Control documents, Calibration form, Temperature & humidity Chart, CAPA, Daily Plans, Emergency repair & maintenance form, SOPs etc. Benefits:  Reference for future use or a means to communicate information to others.  Particularly important to ensure that knowledge is not lost when employee leaves.  Ensure the Quality & Consistency of processed/activities/manufacturing 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 9
  10. 10. B. Records – evidence of compliance Examples are: Humidity and temperature control records, Calibration records, Emergency & maintenance records, Training records, BMRs, Log Books Benefits:  Provide background history  Protects intellectual property (Evidence of an idea or a finding including the date and the responsible person)  Provide legally valid evidence 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 10
  11. 11. The documentation structure for ISO 9001:2008 typically looks like this 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 11 For example, a policy statement could be: All personnel involved in calibration and testing should be competent for the assigned task. For example, it describes how the requirement ‘Personnel should be competent for the assigned task’ can be implemented. Standard operating procedures (SOPs) or Working Procedures are step-by-step instructions for how to exactly perform a specific task, such as calibrating a specific instrument. Records are generated on a day-by-day basis, such as analytical results from product tests or calibration records of a balance. They are used to provide traceability of actions taken on a specific product or batch of products.
  12. 12. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 12 Types of Documents
  13. 13. The laboratory should establish and maintain procedures to control and review all documents (both internally generated and from external sources) that form part of the quality documentation. A master list identifying the current version status and distribution of documents should be established and readily available. FDA statement should drilled into you from day one: On one hand to the work, on other make the document (Document each step before moving to next). All documents must be accurate & written in a manner that prevents errors and ensure consistency. Proper identification, collection, indexing, retrieval, storage, maintenance, and disposal of all quality documents. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 13
  14. 14. Never overwrite or scribbled the entry. Making a Legible Correction: i. Draw a single line through the error, ii. Make the correction next to the error, iii. Write an explanation for the error, iv. Sign and date the correction. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 14
  15. 15. Use indelible (water- resistant/ permanent) black ink, ball-point ink Never use white ink to remove error Do not use pencil or felt-tipped marker Never leave space or blank in the document and draw a diagonal line through any blank fields or empty spaces at the bottom of a page and include ‘N/A’ along with your initials and date. NEVER Back date. When entering repetitive data, do not use DITTO marks. Forget the syndrome “We can fix the documentation later…………” A stamp in lieu of a handwritten signature is not acceptable.  Critical entries must be independently checked (second person verified) 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 15
  16. 16. Handwritten signatures must be unique to the individual and listed within the site signature register to ensure that the signature is traceable to a member of staff. Signatures must never be forged. In the event that a critical member of staff is absent for a time, they must delegate responsibility to another qualified person.  Documents must be approved for use. They must be approved, signed, and dated by appropriate authorized personnel. Data integrity and security shall be maintained.  Records should be made or completed in the personal activity log book at the time each action is taken and in such a way that all significant activities concerning the QC tests of raw materials and products are traceable. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 16
  17. 17. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 17 A system of change control should be in place to inform staff of new and revised procedures. Staff should acknowledge by a signature that they are aware of applicable changes and their date of implementation. Appropriate, authorized SOPs should be available at the relevant locations, e.g. near instruments Archived documents must be retrievable for the appropriate duration Documents should be regularly reviewed and kept current, Documents should be retained and readily available for audits
  18. 18. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 18 When electronically produced, the documentation must be checked for accuracy. Electronic records must be backed up. Backed-up data should be retrievable and stored in such a manner as to prevent data loss. All quality and technical/scientific records (including analytical test reports, certificates of analysis and analytical worksheets) should be legible, readily retrievable, stored and retained within facilities that provide a suitable environment that will prevent modification, damage or deterioration and/or loss.
  19. 19. COMMON DOCUMENTATION ERRORS • Documentation not contemporaneous • Missing signature and dates at the time of activity performed, e.g. missing of date and signatures in data entry logbook at the time of weighing of samples/standards, performing IPQC tests etc. • Incomplete report e.g. missing of signature, date, standard limits in analysis sheets and references in final reports etc. • Non-uniform date and signature • Illegible writing and too many corrections, write- over 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 19
  20. 20. BENEFITS OF GOOD DOCUMENTATION 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 20  Unlock the potential of individual using the document  Amplify the value of the product  Build confidence in the quality of product  Good documentation helps to save the papers  Reduce the efforts to compliance with regulatory bodies  Good documentation enables to achieve the results that you are seeking for.
  21. 21. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 21
  22. 22. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 22
  23. 23. 1. WHO good practices for pharmaceutical quality control laboratories, Annex-1, WHO Technical Report Series, No. 957, 2010. 2. http://www.ivtnetwork.com/article/good-documentation-practices 3. http://www.qmrs.com/work/services/4%20GDPs%20new.htm 4. http://www.labcompliance.com/tutorial/iso17025/ 5. http://www.textlogic.ch/en/blog/writing-policies-and-procedures.html 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 23
  24. 24. "Quality never comes accidently, it comes by practice". 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 24
  25. 25. 10/26/2015TIME Pharmaceuticals (P.) Ltd.,Gaindakot-10, Nawalparasi, Nepal. 25

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