21 CFR stands for title 21 of code of Federal Regulations , a set of rules published by U.S FDA. It includes all food, drugs, cosmetics and medical devices in the U.S.
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Who needs to follow it?
Anyone involved in Biotechnology, pharmaceutical, medical devices, cosmetics industry, food industry and clinical research. -
Rules
A) For electronic records and E signature: ensure that digital data secure, traceable and accurate. Important for companies using paperless work.
B) For GMP for drugs: covers cleanliness, equipments, quality control etc.
C) For Investigational New drugs ( IND): required for starting clinical research in U.S.
D) For quality system regulations for medical devices: it is similar to GMP but specific to device manufacturing.
It’s Matter. Why?
Ensures safety of product, protect patients and other consumers, it keeps data and manufacturing under control. If not obey these rules then warning letter, fine or product recalls.