good documentation practice
- 2. content Introduction What types of documents require to follow Good Documentation Practices? Meaning of signature Purpose of documentation Basic requirements of GDP Preparation of documents Cancellation of GMP records reference 2
- 3. Introduction The GDP can be defined as “Good documentation practice is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. GDPs apply to everyone who documents activities related to cGMP or current Good Manufacturing Practices. A key to Good Documentation Practices is to consider these questions each time you record your raw data: 1. Is it true? 2. Is it accurate? 3. Is it timely? 4. Is it legible? 3
- 4. What types of documents require to follow Good Documentation Practices? Some examples include: • Analytical Methods • Policies • Batch Records • Protocols • Bills of Materials (BOMs) • Test Methods • Certificate of Analyses (CoA) • Training 4
- 5. Cont… Documentation • Certificate of Compliance (CoC) • Logbooks • Laboratory Notebooks • Calibration records • Quality records - non-conformances - CAPAs - internal inspection reports - change control 5
- 6. Cont…. • Standard Operating Procedures • Validation Documents (IQs, OQs and PQs) • Work Instructions • Product and Sample Labels 6
- 7. The Meaning of Signature Generally speaking, when signing your name to a GMP document, you: 1. Confirm your unique identity. 2. State that you have the authorization to perform, verify, check, review or approve the activity associated with your name. 3. Recognize that your signature and initials cannot be taken back; once signed, you are personally, professionally and legally responsible for the action taken. 7
- 8. Purpose of Documentations • Defines specifications and procedures for all materials and methods of manufacture and control • Ensures all personnel know what to do and when to do it. • Ensure that authorized persons have all information necessary for release of product • Ensures documented evidence, traceability, provide records and audit trail for investigation • Ensures availability of data for validation, review and statistical analysis. 8
- 9. Basic requirements of GDP Always record the entries at the time of activity simultaneously. Always record the date with the signature in GMP records. Always enter the data directly into the GMP records in the English language. Never use whitener or eraser to re correct the sentence, just strike off the sentence with simple line and write the correct sentence with sign & date. Never sign for someone else on any document. Only sign for the work that you have performed yourself. Never backdate GMP records. Documentation and records used throughout the manufacturing process,as well as supporting processes,must meet the basic requirement of GDP. 9
- 10. Preparation of documents Clear and concise titles should be used for headings, tables, graphs, etc.. Pages in master document should be numbered as X of Y. All documents should have the signature and date of the person who prepared the document, reviewed & approved the document. All documents should have effective date, approval date, revision no. & supersede no. Respective SOPs should be followed while preparing the documents. When creating a document, consider the context in which the document may be used in future and reader has enough background information. 10
- 11. Cont…… Training of the document should be planned only after approval of the document and shall be completed before the effective date. Time should enter in documents in 24:00 hrs cycle. Entries in log book should be made in chronological order. entries should never be pre-completed. Data should be recorded by trained& authorised person only. Manual entries should be reviewed and singed by the second person for accuracy & completeness. 11
- 12. Cancellation of GMP records Cancellation of GMP records should only be allowed in the rare case with the approval of QA and in exceptional cases such as spillage of chemical on the record. Event investigation should be followed to determine further course of action. the reason for cancellation should be documented for cancellation of the document and signed by area person-in-charge and QA. 12
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