Cleaning validation of pharmaceutical process equipment

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 based on all 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.)

Methodology

This course proposes deep details for all part of the global cleaning validation strategy in pharmaceutical activities. Innovative and easy-to-implement solutions to manage cleaning validation are proposed and explained in
details with examples and practical exercises. These new approaches keep all Quality Assurance expectations and the compliance with FDA/EU requirements. At each step, the actual regulations (as GMP Annex 15) 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 before all activities of cleaning validation
• Cleaning development and cleaning optimization
• Definition of critical surfaces and sampling plan by risk analysis approach
• Definition equipment train (Equipements/Products matrix) by an innovating and easy to implement solution
• Definition of worst case equipment and worst case product
• Calculation of acceptance criteria (MSC : Maximum Safe carryover) according to new regulatory aspect (integration of the PDE/ADE) for pharmaceutical processes (sterile, non-sterile), APIs, cosmetics,
• Biotechnology activities
• Sampling methods according to different contaminants and recovery tests
• Analytical methods linked to sampling methods
• Implementation of a qualified visual inspection control in production
• Personnel authorization for sampling and visual inspection
• Cleaning validation runs
• Documentation expectations at each step (Cross Contamination Control Strategy, Cross Contamination Risk
• Assessment, Cleaning Validation Master Plan, SOP’s, protocols & reports, etc.)
• Monitoring of the validated state by statistical trend
• Quality assurance documentation (Change control, deviation, etc.)
• Conclusions

Learning objectives

At the end of this course the participants will have acquired the knowledge necessary for the rational and a compliant implementation of a cleaning validation program for manufacturing equipment with easy to
implement solutions.

Regulatory reference

EU GMP Part I, Chapter 3 and 5 (03/2015)
EU GMP Part II (08/2014)
EU GMP Part III
EU GMP Part IV
EU Annex 15, Qualification and Validation (10/2015)
EU GMP Annex 1 (last version)
IPSE and PDA guidelines

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