Available as an in-house course

How to Audit API Manufacturers

Dates

13 November 2008

Venue

The Window Conference Centre, London UK

Duration
1 Day

Cost

£600.00 + VAT £105.00 - Total £705.00

A reduced rate if booked with "GMP Auditor Training"

An "early bird" reduced rate of 10% is available if booked by Friday 22 August 2008

Synopsis

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

Course Speaker

Dr David Inglis isdirector of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry.  He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs.  He has a Ph.D. degree in enzyme chemistry (affinity chromatography).

During more than 29 years in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance.  He successfully pioneered automated HPLC methods, then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates for use in clinical trials.

Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA “Systems” based inspections. He has extensive experience of being the lead spokesman during major regulatory audits.

Dr Inglis is a specialist in cGMP training and QA system improvement.  His

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

Close of Seminar