Cleaning Validation - Strategy, techniques and regulations

Industry field:

Pharmaceutical industry

Course description:

"From 1999 to 2006 around 35% of the "Warning Letters" from the FDA contained remarks on cleaning and cleaning validation!

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. The course content is based on the cross-over experiences of Mr. John Lee (former FDA investigator) and Mr. Frédéric Laban (senior international consultant) on the subject, particularly on the most recent statements from the FDA, the recommendations of SFSTP and APIC;  and the current EU GMPs.

Objectives

The course will provide the attendees with a better knowledge of regulatory requirements and techniques to be able to build their own cleaning validation strategy in accordance with current US regulations and to get the most effective “payback” in terms of productivity, safety, ergonomics and environment protection.

Methodology

Using examples and practical exercises in groups, 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:

• Recognition of bad practices, definition of the golden rules of cleaning

• GAP-analysis between US and European regulatory expectations

• The prerequisites for the validation

• Definition of specifications

• Qualification of material and chemicals

• Qualification of personnel

• Definition of cleaning validation, general methodology

• How to build up its own strategy, optimizing the “payback” in addition to the GMP compliance

• Calculations of acceptance limits

• Sampling methods

• Analytical methods

• Various strategies, methods of grouping and "worst case"

• Monitoring, change control and revalidation

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 or chemical sites, from clinical to manufacturing batches.

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» Download course folder (PDF)

» Registration

» Download course folder (PDF)

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