GMP in Primary (API) Manufacturing

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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.

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
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

David Inglis

David Inglis

David is a consultant 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 PhD in enzyme chemistry (affinity chromatography).

With over 30 years experience in quality assurance in the pharmaceutical industry, David has 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.

David 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.

David is a specialist in cGMP training and QA system improvement. His flagship improvement package details a system of secure GMP compliance at competitive cost. For conceiving and developing this package, David received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.

  • 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

“An excellent course, I would recommend to colleagues”

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