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Microbiological Quality Considerationsin Non-Sterile Dosage Forms Manufacture

Conducted by: Ms. Karen Ginsbury
SKU: 241119
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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    • FDA Draft Guidance on Microbiology for Non-Sterile Drugs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:

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    • FDA Draft Guidance on Microbiology for Non-Sterile Drugs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 of Non-Sterile Products
      • <1112> Application of Water Activity in Determination of Non-Sterile Pharmaceutical Products
      • <1231> Water for Pharmaceutical Purposes
    • USP/Ph Eur Monographs:
    • <60> <61> <62> Microbiological Tests for Non-Sterile Products
    • Environmental Monitoring vs. Microbial Limit Test (vs. Bioburden)
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Dates: 
  • 02/09/2024
  • 09/09/2024

מתעניינים? לחצו כאן

    Course location: Hybrid: Kiryat Weizmann Ness Ziona or ZOOM
    Duration: 2 Day Course
    Hours: 09:00 - 17:00
    Credits: 2
    Course Language: עברית

    Course price: ₪4,600 + VAT
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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    • FDA’s draft Guidance on Microbiology for Non-Sterile Drugs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

    Karen Ginsbury
    B.Pharm, M.Sc, MRPharmS, has over twenty five years of experience
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    תחזוקת מערכת האיכות בזמן מלחמה QMS

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