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How to Audit API Manufactuers (1 day)

  January 19, 2012  
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 FDA draft guidance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?

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


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 manage-ment

Auditing of an API site (I)
 Documentation and systems review
 Facilities and support services
 Materials control
Auditing of an API site (II)
 SOPs and SOP training
 Testing laboratories
 Packaging and labelling
 Storage and distribution

Summary of Key Issues

Close of Seminar

Organized by: PharmaTraining Ltd
Invited Speakers: DR DAVID INGLIS is a consultant specialising in GMP/Quality Assurance
for the manufacturing sectors of the pharmaceutical and consumer healthcare
Deadline for Abstracts: N/A
Registration: 10% discount if booked and paid 8 weeks prior to course
E-mail: judy@pharma-training-courses.com
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