Details
General
This is a plain SOP Template / Format or Form.
Table of Content (just Headers):
Purpose
Objective
Regulatory basis, reference documents
Responsibility and accountability
Related documents
Definitions
Procedure
Description of the Procedures and Processes
Attachments
SOP distribution
Health, safety and environmental considerations
Size and Format:
- Microsoft Office 2003
- Word File
- 6 pages plain procedure
GMP News
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Is FDA turning into a profit center?
The FDA commissioner, Dr. Margaret “Peggy” Hamburg went into action after nomination with changes to be applied at the FDA. The commissioner today is under high pressure by the congress on the one hand and the public on the other hand. The economic crisis in the US as well as the forthcoming 2012 election of the US president has put enforcement on top of the FDA’s agenda. It is recognized by industry that FDA is much more quickly posting a warning letter after an unsatisfactory inspection. Consent decrees will not be fare a way any longer if persistent violations are proven. Currently there are many cases in the industry of well known companies which struggle well knowing that a warning letter or consent decrees will have a critical impact on reputation, sales, product availability on the market as well as companies share price. As a consequence it is even more important for the industry to meet the FDAs expectations by having founded and implemented a robust GMP Quality Management System and to take inspection preparation and management back to the top priority goals of the company.
