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
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
