How to Audit API Manufacturers

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This one day seminar is aimed at QA staff in drug product 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

The course will commence with coffee/tea and registration from 8.30, course proper at 9.00 and we anticipate the course will finish at 17.00 each day

Background to ICHQ7 and EU GMP Guidelines Part II

  • History of GMP for APIs within EU and USA
  • What role do these documents play?
  • How they will be enforced?
  • How to go about implementing the requirements
  • GMP expectations of the API Manufacturer

Why Audit API Manufacturers?

  • EU Directive 2004/27/EC (Regulator’s view)
  • Recent legislation and practice
  • Role of products manufacturers
  • Regulatory review of audit reports
  • Regulatory expectations of the API manufacturer

Workshop 1 – 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)

  • General preparations
  • Quality (Management) System
  • Facilities and support services
  • Validation activities
  • Summary of Key Issues

Auditing of an API site (II) + Open Forum

  • SOPs and SOP training
  • Materials and Production Controls
  • Calibration
  • Testing laboratories (QA/QC)
  • Packaging and labelling
  • Storage and distribution

Implications of EU Directive 2004/27/EC on Medicinal Product Manufacturers

  • Role of medicinal product manufacturers (including legal responsibilities)
  • Developing requirements
  • Risk assessment
  • Assessment of potential suppliers
  • Resource and cost implications – supplier auditing
  • Decision making and managing risks
  • Developing contracts
  • Maintenance/policing of GMP compliance at the supplying site

Summary of key issues

17.00 Close of Seminar


  • Supplier auditors for drug product 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”

Register Interest in this Course