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. Further, in its Q7A Guideline the ICH
specifies that the same type of review should be applied to
active pharmaceutical ingredients. 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.
Other Courses of Interest
Applied cGMPs for Pharmaceutical and Allied Industries
Conducting Effective Quality Audits
Documentation Management and Control
Mar 05 2012, New Brunswick, NJ
Documentation Management and Control
Jun 07 2012, Amsterdam, The Netherlands
ICH Q10: Pharmaceutical Quality System
ICH-Q7
Mar 19 2012, New Brunswick, NJ
ICH-Q7
Jun 25 2012, Amsterdam, The Netherlands
Pharmaceutical Quality Assurance and Control
Mar 19 2012, Amsterdam, The Netherlands
Root Cause Investigation for CAPA
Apr 17 2012, Amsterdam, The Netherlands
FDA Drug Development and Compliance
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