Your cleaning validation processes may no longer pass muster with the FDA and EU authorities. Recent revisions to permitted daily exposure (PDE) guidelines for setting limits in cleaning validation mean you have to establish new processes.
Instead of previously used acceptance criteria such as 10 ppm or 1/1000 of the therapeutic does of the previous product, the sole admissible criterion is a toxicological risk assessment based on permitted daily exposure/acceptable daily exposure (PDE/ADE) values.
Current FDA warning letters show rigorous enforcement. Plus, revisions have come from the American Society for Testing and Materials (ASTM), the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S made revisions to Chapter 3 (premises and equipment), Chapter 5 (production) and Annex 15 (qualification and validation) of its PIC/S good manufacturing practices (GMP) guide.
All have required drugmakers to establish health-based exposure limits (HBELs).
Drugmakers must now come up with a scientific, substance-specific justification for the limit value calculation for active substance and cleaning agent residues.
Not to mention that cleaning validation is subject to an intensive review within the framework of official inspections by the FDA and EU authorities.
How do you implement the current requirements and maintain compliance?
Pharmacist Sabine Paris, PhD — a senior GMP expert and chief editor of GMP Compliance Adviser — has the answers in this webinar. Using a case study from inspection practice, Dr. Paris will explain how to implement the current requirements for setting limits in cleaning validation.
- The new requirements of EMA, PIC/S and ASTM PDE Guidelines
- The complex derivation of PDEs
- Important aspects of PDE reports
- The disadvantages of the traditional acceptance criteria (10 ppm, 1/1000 doses)
- Implementation of PDEs in cleaning validation
- The risk identification in a multipurpose facility
- Alternatives to PDEs
- Expectations of Good Manufacturing Practices (GMP) inspectors
Stay compliant and stand up to the most rigorous cleaning validation reviews. Join us by registering today.