ICHQ7 & Q11 (5 of 7)
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This document summarizes a presentation on the development and qualification of suppliers. It discusses the importance of auditing suppliers to ensure quality and prevent issues like contamination or non-compliance. The presentation outlines key aspects of auditing like reviewing documentation, inspecting facilities, and assessing quality management. It argues audits are necessary to detect issues and ensure a safe supply chain, as systems based solely on trusting suppliers through questionnaires or virtual audits are not sufficient. The presentation closes by urging companies to prioritize quality and safety over profits to prevent irreversible harm.
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• Over all responsible for IPQA Activities (both manufacturing and
packing area of solid orals, Nasal spray and Liquid dosage forms)
• Ensure the compliance of quality events like deviation
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• Active participation in root cause investigation and proposal of CAPA for deviation, market complaint and batch failure.
• Effectiveness check of implemented CAPA in shop floor.
• Calibration Management –ensure calibration of all IPQA instruments as per schedule.
• Skilled in preparation and review of Annual Product Quality Review (APQRs)
• Review of SOPs/work instructions-Gap identification and compliance of the same.
• Conducting in-house cGMP audits to ensure compliance and sound functioning of the process.
• Provide training regarding any changes to existing system and introduction of any new system.
• Knowledge on OOS, OOT, Site Master File.
• Hands-on experience in preparation of Process validations, cleaning validation, hold time study protocols and BMR and BPR preparation.
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The document discusses implementing a quality assurance framework for plant breeding. It outlines benefits like increased competitiveness, knowledge transfer within institutes, and improved partnerships. Examples of relevant quality standards like ISO 9001 and ISO 17025 are provided. Implementing a framework requires documenting processes, training, equipment records, and validating data. Buy-in requires incentives for compliance since currently consequences are lacking. The framework must be tailored to different partners' capacities and emergencies may require early solutions. Quality systems can demonstrate competence and improve projects if expectations are appropriately set.Brian_Oliver_Resume
Brian Oliver is an experienced mechanical engineer with over 15 years of experience in product development from concept through production. He has worked in various industries including transportation, aerospace, medical, computing, and lighting. Currently he is a Senior Research and Development Engineer at Becton Dickinson where he provides technical leadership in concept to production development projects, developing over 20 critical components for a robotic drug compounding system.
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The document discusses Integrated Product and Process Development (IPPD), which is a Department of Defense management technique that simultaneously integrates all essential activities through multidisciplinary teams. IPPD provides a systematic approach to product development that achieves timely collaboration throughout the product life cycle to satisfy customer needs. The document then outlines the tenets of IPPD and how it relates to the CMMI process areas at different maturity levels. It also discusses the Rational Unified Process (RUP) framework and its iterative development cycle.
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Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
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Ashish Kumar Mishra has over 9 years of experience in quality assurance and operations management. He is currently an Assistant Manager at Cargill India Pvt. Ltd., where he oversees quality assurance operations at three locations. He has expertise in implementing food safety and quality standards like HACCP, ISO 22000, and FSSC 2200. He also has a Green Belt certification in Lean Six Sigma and has received several awards for his work improving processes around recipe accuracy, moisture management, and inventory control.
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- 1. Discussion Forum on ICH Q7 & Q11 Development & Qualification of Suppliers Dr. Obaid Ali Deputy Director, DRAP Member ISPE, PDA 23 April 2017 (Program A) 21 May 2017 (Program B)
- 2. Development & Qualification of Suppliers
- 3. Opening Message Science, Trust and their Verification Frame Strategy & Progressive Initiatives Closing Message
- 4. Ingredients Process Product Opening Message
- 5. Ireland- Paroxetine, Oct 2013 Contaminated with waste tank Did not give attention, kept continuance of distribution Recall … RA Look Analyze Predict
- 6. Science, Trust & their Verification Independent Pre-Audit Assessment Site Inspection Post Audit Assessment
- 7. Flow diagram(s) of manufacturing processes Manufacturer(s) Quality management Personnel Building and facilities site/ building map Process equipment Documentation & records Materials management Production and in- process controls Insight Cont’d
- 8. Packaging and identification labeling of ingredients and intermediates Storage & distribution Laboratory controls Validation Change Control Rejection and re-use of materials Complaints and recalls Contract manufacturers & laboratories Agents, brokers, traders, distributors, repackers, & relabelers Insight
- 9. Frame, Strategy and Progressive Initiatives
- 12. Let’s challenge and speak Audits are not required Sample testing is sufficient Only questionnaire is sufficient Virtual audit is sufficient NO YES
- 14. Paper Tiger otherwise invites and promotes • Negligence/slopiness • Cutting corners • Deliberate non-compliance • Cheating • Counterfeiting • Crime
- 16. Patient Safety
- 17. Why Audit is necessary? Detects GMP non- compliance Detects Fraud and Counterfeiting A system based on trusting on audits only does not work!
- 18. Why Audit is necessary? Because patient safety is of paramount importance Detects GMP non- compliance Detects Fraud and Counterfeiting A system based on trusting on audits only does not work!
- 19. Global Radar navigates Mandatory API GMP Certification Global prioritization of API inspections Focus on fraud & counterfeiting Sanctions & penalties Legal liability of Qualified Persons
- 20. Progress but do not pursue profit at the expense of consumer safety. It will not favor every time Closing Message
- 21. Your product is your child. Please take care because some time damages of uncertainty are irreversible Closing Message
- 22. Please make zero tolerance as a habit ... “But no one came. Because no one ever does” (Thomas Hardy .. Jude the Obscure) Closing Message