Documents system
- 1. DOCUMENTATION SYSTEM cGMP Training Program By Deepak Amoli CERTIFIED TRAINER FROM QUALITY COUNCIL OF INDIA deepakamoli@gmail.com
- 2. The Documentation system is the Key of the GQAPs. It initiates the format and traceability of the entire system. The approved documents may be confidential and, therefore, should be maintained in a controlled and traceable manner. Purpose of documentation system is to provide a system for the complete documentation of all required records, logs, and instructions necessary for compliance with ICH Q7 & 21 CFR parts 58, 211 and 606. Written procedures shall exist for all production, quality control, packaging, and labeling processes, that occur during the production of a controlled product.
- 3. WHY DOCUMENT? 1. Spoken information. 2. The changes in the message are difficult to reconstruct at a later point in time. 3. Oral communication is subject to interference. Document is an organized form of information that can serve as legal evidence or proof.
- 4. Regulatory reasons for documenting From GMP perspective, agency personnel, when doing on- site audit, will want written, documented answers to the following four basic questions: 1. What are you doing? 2. Why are you doing? 3. Are you doing what you have said? 4. Are things under control?
- 5. Why written procedures are important? Written procedures six important functions in our company: Standards of performance: It help in establishing and forcing work standards. It helps to ensure that the same job is consistently performed the same way each time. Instruction: It helps instruct employees at all levels of the company. Reference: It provides a time saving checklist needed to make sure each step is carefully followed. Control: It helps us to look for when auditing and how to evaluate results for compliance. Review: Putting procedures down on paper provides us with the opportunity to see how we can improve our operations and plan for performance improvement. Documentation: Written procedures are a record of how you do certain operations.
- 6. Documentation System: The tasks involved in producing a document are integrated into a system. A simple model flow of documentation process is : generation, review, approval, distribution and retention or destruction. There is not a “one-size-fits-all” solution to documentation. Some of the factors that need to be consider as you establish or improve system are: Regulatory requirements and expectations of agencies that inspect your firm. Industry practice Your firms integration and use of human performance and quality concepts. Your firm’s business practices. Site and location issues
- 7. Records and reports Records and reports are the “containers” of data and information that: Communicate what happened, what was done, or the rationale behind a decision; Provide a historical reference; Demonstrate fulfillment of a regulatory requirement; and Provide evidence that something was done or of a fact. Examples of records: BMR, log books Examples of Reports: PDR, Technology transfer reports, validation reports, investigation reports.
- 8. SOP – Standard Operating Procedures - Objective - Scope - Responsibility / Accountability - Reference - Procedures - Reason for revision - Abbreviations - Attachments
- 9. SOP Compliance - Training - Execution as per SOP - Documentation - Review and verification - Suggestion / revision
- 10. Share the KNOWLEDGE gained with others to make them aware of cGMP The more we share, more we learn. Practice the learning Thanks deepakamoli@gmail.com