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what is mean by 21 CFR PART? In that what is 21 ?
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Answer / g. subrahmanyam
CFR is Code of Federal Regulations is the codification of
the general and permanent rules and regulations (sometimes
called administrative law) published in the Federal Register
by the executive departments and agencies of the federal
government of the United States. The CFR is published by
the Office of the Federal Register, an agency of the
National Archives and Records Administration (NARA). The
CFR is divided into 50 titles that represent broad areas
subject to Federal regulations. Out of 50 we will use
Title-21 which refers to Food & Drugs. Hence we call it as
21-CFR. This 21-CFR is further divided into 1500 parts.
Out of which we will be using frequently 11 (i.e. 21-CFR
Part-11) for Electronic records (i.e. 21-CFR Part-211) and
211 for Good manufacturing practices.
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