CfPA - The Center for Professional Advancement, New Brunswick, NJ
January 27-28, 2010
Who Should Attend
This course should benefit those who need to know how APRs for drug products and/or active pharmaceutical ingredients should be designed, organized and otherwise managed. The course will benefit individuals in:
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Production
• Technical Services
• Site & Corporate Management
It should also be of interest to suppliers to the industry. Description
The FDA’s cGMP regulations require that an annual review (commonly called “Annual Product Review”) be performed for all drug products. The EU GMP regulations and also the ICH Q7A guideline for the GMP’s for active pharmaceutical ingredients have corresponding detailed requirements. In each case, there is a general requirement that the quality of each product be reviewed at least once per year “to determine the need for changes in specifications or manufacturing or control procedures” and that any adverse or unexpected trends be identified so that corrective action can be taken. It is indicated that the review should encompass “a representative number of batches” and include considerations of “recalls,” “product complaints,“ “returned & salvaged products” and “investigations” performed as a result of deviations encountered during production. The wording used is very broad and provides little guidance on what details should be addressed. This course sets out to define what details should not only satisfy the FDA’s expectations but should also help meet the firms economic goals of understanding product quality & identifying areas for correction & improvement. The course includes a consideration of the system by which APRs can be effectively and efficiently prepared and issued as well as the details which the SOP should address.
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