Annual Product Reviews (APRs) For Pharmaceuticals
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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.