Understanding regulation of aseptic
processing and filtration applications
One-day course
Course Description
The course provides an in-depth review of current global regulatory practice for filtration applications in aseptic processing. Detailed discussion of the qualification and validation of these applications will enable you to answer any questions which might arise during inspections or audits.
Ordering Information: TRAPVALID
Learning Goals
- Explain how to design aseptic filtration processes that include post-sterilization and pre-use as well as post-use filter-integrity testing procedures during production.
- Discuss the regulatory authority’s current expectations for aseptic filtration and specific validation of filtration applications.
- Interpret guidance on filtration and aseptic processing from the U.S. Food and Drug Administration (US FDA); European Medicines Agency (EMA); International Conference on Harmonization (ICH); World Health Organization (WHO); Parenteral Drug Association (PDA) and International Organization for Standardization (ISO).
- Describe filter validation studies such as microbial retention testing, extractable and leachable substance determination, compatibility studies, sterilization, formulation adsorption, and product-related filter-integrity testing.
- Create your own validation master plan for filtration.
- Explain filter validation studies to your regulatory inspector or internal auditor.
Course Content
- Interpreting the current regulatory environment
- Understanding how to incorporate filter validation in a validation master plan
- Incomplete filter validation documentation
- Lack of expertise in preparing for regulatory inspections
- Problems understanding filter supplier’s validation documentation
Prerequisites
You should have a working knowledge of cGMP, validation, qualification and the relevant regulatory guidelines (e.g. Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice, FDA Guidance for Industry, Sept. 2004 - Manufacture of Sterile Medicinal Products, EU Guidelines to Good Manufacturing Practice, Volume 4, Annex 1, Nov. 2008).
Who should attend?
The course is primarily designed for quality assurance, quality control and validation personnel with a basic understanding of filtration practice.
What will you receive?
- A copy of the course materials.
- The latest regulatory guidelines.
- A certificate of attendance.
Course Schedule and Program
9:00 - 17:00
- Welcome and course introduction
- Current regulatory requirements
- Sterilizing-grade filter - definition and manufacturing
- Validation master plan (VMP) for filtration applications
- Bacteria retention test
- Filtration line design for pre-use integrity test
- Extractables and leachables
- Filter steam sterilization validation
- Conclusion
Enrollment limited to 15 participants
We recommend early booking to ensure a place.
Price
Please contact your local representative or email ilearn@merckgroup.com for a quote.