PharmaTraining Services, London UK
20 & 21 November 2007
Why audit API Manufacturers?
*EU Directive 2004/27/EC (Regulator’s view)
*What are the requirements?
*What are the similarities with the FDA GMP requirements for APIs?
*What are the expectations from API Manufacturers?
*What role should secondary manufacturers play?
*How will regulators assess compliance with these requirements? Background to ICHQ7a and EU Guide Part II (formerly Annex 18)
*History of GMP for APIs
*What role these documents play
*How they will be enforced
*GMP expectations outlined
*How to go about implementing the requirements FDA GMP expectations of API manufacturers
*FDA draft guidance
*Legal basis of ICH Q7a
*Details of what is required
*How is it enforced?
*Differences and similarities with EU requirements
*How would manufacturers comply with both regulators’ requirements? Workshop I:
How to identify and select a GMP compliant API supplier
Preparing for GMP assessment of an API site
-identifying the GMP relevant activities
-assessing the rational for GMP relevance of activities
-identifying the processing steps
-list of key documentation
-identifying the critical steps impacting your secondary product Lunch Implications of EU Directive 2004/27/EC on Drug Manufacturers
*what role manufacturers of the secondary products should play on enforcing these requirements
*what is the impact on manufacturers?
*how to apply the requirements to non EU API sites
*what impact this will have on cost of APIs? Workshop 2:
Handling Manufacturing Deviations
*Basis of proactive deviation management
*Identifying and documenting GMP non-compliance incidents
*Monitoring and reporting
*Key aspects of knowledge management
*Framework of critical deviation management
*Continuing governance of critical deviations management Auditing of an API site (I)
*Documentation and systems review
*Facilities and support services
*Validation
*Materials control
*Auditing of an API site (II)
*SOPs and SOP training
*Calibration
*Testing laboratories
*Packaging and labelling
*Storage and distribution Summary of Key Issues Close of Seminar
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