As a recipient of a response warning letter, it is important to follow the basic steps outlined below to ensure a timely and effective response. 1) Acknowledge receipt of the letter through certified mail, informing the FDA that we intend to respond within 15 business days. This initial correspondence should be brief, simply and serve … Continue reading How to respond to 483 observation & Warning Letters?
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Common terms used in USFDA Inspections
Types of USFDA inspections. Pre-approval/Application-based inspection = conducted before the USFDA approves a new drug, biologic, or medical device for marketing in the US. Routine/GMP/Surveillance/Post marketing inspection = conducted periodically to ensure that the manufacturing facilities and processes continue to comply with cGMP regulations. Compliance follow-up = conducted to verify that a facility has taken … Continue reading Common terms used in USFDA Inspections
Quality Control in Pharmaceuticals Principle and General information
Quality Control Principle : Quality Control is concerned with sampling, specifications and testing as well as the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control … Continue reading Quality Control in Pharmaceuticals Principle and General information
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