How to Audit API Manufacturers

Overview
This one day seminar is aimed at QA staff in drug products manufacturers and especially their QPs who have specific responsibilities under directive 2004/27/EC.

QPs are required to declare that the active materials used in each of their products have been manufactured to GMP as interpreted by the EU.

The seminar includes:

• the background to current GMPs for APIs
• FDA and EU interpretation of GMPs for APIs
• specific opportunities from the guidelines that API manufacturers may exploit
• specifics of what to look for when auditing an API site.

Course Programme

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FDA draft guidance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