How to Audit API Manufacturers

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. 

Participants will learn about the legislators’ perspectives and the key differences between APIs and products, which lead to different audit techniques and thought processes when auditing API manufacturers.  

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.

Who should attend

· Supplier auditors for drug products manufacturers

· QPs in manufacture of drug products

· QA managers who support the QP / declaration

· QC managers of drug products manufacturers

· Production managers of drug products manufacturers

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· FDA draft guidance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

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