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Microbiological Quality Considerationsin Non-Sterile Dosage Forms Manufacture
The objective of this course is to understand microbiological concerns from a process, product, patient and regulatory perspective:
- To be able to review processes
- To identify microbial hazards
- To put in place appropriate controls
- Microbial Control Strategy
- FDA Draft Guidance on Microbiology for Non-Sterile Drugs
- USP / Ph Eur General Microbiology Chapters:
- <1111> Microbiological Examination...Continue reading
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Issues to be covered
- What is a control strategy for microbial risks
- Contamination prevention vs. mopping up the mess
- FDA’s draft Guidance on Microbiology for Non-Sterile Drugs
- EU Annex 1 for Sterile Products – applicable or not?
- WHO Guides? (HVAC for non-sterile manufacturing, other?)
- The pharmacopoeias: general chapters – process vs. product monographs
- The role of Environmental Monitoring
- Cleaning and Disinfection
- Recent inspection findings PIC/s Concept Paper on revision of Annex 11
- What awaits industry in future inspections?
- Quality Unit role vs. rest of management
- Interactive Group Activity:
- Develop a framework for a microbial control strategy in small groups for different types of non-sterile dosage forms
Who should attend
- API / Drug Substance and non-sterile Finished / Drug Product manufacturers
- R&D, Technology Transfer, QC / Microbiology laboratory personnel
- Those involved in clinical trials, regulatory affairs, and manufacture, testing and oversight of microbial aspects of Investigational Medicinal Products will also find the course very useful
- The course will be of particular value to small “virtual” start-up companies manufacturing and testing their product at CDMOs – contract manufacture and / or contract microbiology testing. In the absence of a microbiologist in the company, the course will allow understanding of the risks which need to be managed
Benefits to the Participants
Participants will come away able to develop a systematic microbial control strategy tailored to their process.
The strategy
- Is tied in to and an extension of risk assessment/ control / management
- Considers the process(es) and product(s)
About The Lecturer
