USFDA in its guidelines on Quality System, it has mentioned guidelines regulations, means it’s mandatory for pharmaceutical manufacturing units to follow the Guidelines.

US FDA guidelines on Quality audits mention that Pharma Manufacturer must have a Procedure for quality audits, these must ensure and establish that Quality systems are followed and are in state of compliance.

In event of any non conformity auidts must caputure the same and must have a system for coorective and prevention action such that the non confirmity do not repeat.

US FDA guidelines Quality audits
US FDA guidelines Quality audits


The Audit findings must be reviewed by responsible managmet team, clear risposnsiblity must be drawn for the compliance. Frequency is not mentioned in guidelines that means audit may be done as per the manufacturer’s SOP for frequency.

One of important point mentioned in guidelines is a person who is responsible for compliance or the operation can not be part of the Auidt team, to rule out conflict of interest.

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