Active Pharmaceutical Ingredients

Who Should Attend
This course is for individuals working in all phases of human and veterinary Active Pharmaceutical Ingredients (API) production including:

  • Pilot and commercial production 
  • QA/QC
  • Technical services 
  • Regulatory affairs
  • Process development 
  • Validation
  • Regulatory agency investigators

The presenters discuss requirements for a GMP compliant API operation, everyone's role in achieving compliance and penalties for noncompliance.

Description
This course prepares attendees to meet the challenges they face in the heavily regulated pharmaceutical industry. API manufacturers must ensure that GMP principles are applied to API production and there is extensive focus on relevant operational, control, and regulatory activities with specific examples. This information is essential for successfully meeting GMP requirements that are sometimes only incompletely expressed by official regulatory guidance documents including ICH Q7.

Some of the topics discussed are design, construction and qualification of GMP production facilities; selection, qualification and cleaning of equipment; process development and technical transfer; validation principles and process validation. Regulatory agency compliance oversight, and duties of the quality unit to establish and manage systems required to maintain compliance will be discussed. Throughout the program there are interactive class exercises. On the last day of the course, participants receive instructions on managing an FDA inspection followed by a workshop in which participants prepare written responses to simulated FDA-483s (List of Inspectional Observations) based on actual FDA observations. The exercise will result in a valuable exchange of information and approaches with your colleagues.