Active Pharmaceutical Ingredients
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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.