|Product Name:||Annual Product Review Guideline|
|Our Price:||$40.00 |
|Product Weight:||0.4 lb.|
| Product Detail|
|The annual review of product operations is a process that can be arduous and dreaded by quality professionals. Our staff has made every effort to generate an outline of what is necessary to understand the systems necessary to properly compile an Annual Product Review. An evaluation should be made to verify all local or corporate standards are met concerning the program and outline provided in this guideline.
This 13-page guideline was written to provide an outline of what is required to become compliant with 21 CFR, 211.180(e). The contents are as follows:
Six Requirements APR for APIs
Senior Management Approval Interpreting APR Results
Seven Basic Points for Effective APRs FDA cGMP Notes on APRs
Contents of an APR SOP on APR
As a bonus, we are also including an electronic copy of the Annual Product Review SOP – a $60 value free.
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