What is 21 CFR? And why it is required
Title 21 CFR Part 11of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).
Title 21 of the CFR is reserved for rules of the Food and Drug Administration.
21 CFR 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS.It has 11 sub part from subpart A to K. Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS
USFDA plant in India follows 21 CFR regulations.
CFR means Code of federal regulation: 21 is nothing but the title name it comes from…
US government is a federal government , in this it is having the some of regulations. For those it gives the numbering.those are 1-50 titles.
In that the 21 title name is FOOD and DRUGS.
It is also known as USFDA. And It is having
3 chapters,9 volumes and 1-1499 parts.
In that part 211 is for GMP for finished pharmaceuticals.
If you want to know more,you can see the e-CFR.
Maybe it is very important to mention 21CFR820 (Quality system).
Would you please share the pdf for this