Cleaning validation of pharmaceutical process equipment

– New GMP requirements
– What about PDE
– Define your best strategy
– Methods and techniques

Course description

The state of control regarding our cleaning processes is a constant issue by our regulators. Beyond purely “compliance” issues, it is a major point for control of the manufacturing process. This course is intended for manufacturers of final dosage pharmaceuticals, active pharmaceutical ingredients, and intermediates, as well as for biotech companies and R&D. This course is constantly updated according to state of the art and the changing CGMP expectations, focused on the aspects of technical and regulatory (US and EU) updates associated with validation of cleaning processes. Update are performed also according to guidelines or other important texts (PDA, ISPE, APIC, etc.). This course proposes deep details for all part of the global cleaning validation strategy in pharmaceutical activities. Biotechnology activities are also treated. Using examples and practical exercises, linking together techniques, quality assurance and compliance with FDA/EU requirements. At each step, the regulations are recalled and interpreted into operational and achievable recommendations.

Course outline

• Key points of US and European cGMP’s
• Principle, definition and scope of cleaning validation
• Cleaning validation prerequisites (team and people, equipment and utilities qualifications, etc.)
• Cleaning development and cleaning optimization
• Definition of critical surfaces and sampling plan
• Definition and use of equipment train
• Definition of worst case equipment and worst case product
• Choice of tracers according to different contaminants
• Calculation of acceptance criteria according to new regulatory aspect for pharmaceutical processes, APIs, Biotechnology activities
• The choice of sampling methods according to different contaminants
• Analytical methods linked to sampling methods
• Number of cleaning validation runs
• Documentation expectations at each step (cross contamination risk assessment, validation master plan, SOP’s, protocols & reports…)
• How to follow the validation: Monitoring, change control and potential revalidation
• Conclusions

Learning objectives

At the end of this course the participants will have acquired the knowledge necessary for the rational and compliant implementation of a cleaning validation program for manufacturing equipment on pharmaceutical, cosmetic, biotechnology or chemical sites, from clinical to manufacturing batches.

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