PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
16 May 2012
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FDA draft guidance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 regula-tors’ requirements?
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
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?
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 manage-ment
Auditing of an API site (I)
Documentation and systems review
Facilities and support services
Auditing of an API site (II)
SOPs and SOP training
Packaging and labelling
Storage and distribution
Summary of Key Issues
Close of Seminar