Laboratory GMP Audits

What type of problems can be found during a Laboratory GMP Audit?

Procedures

• Written standard operating procedures were inaccurate, incomplete, and contained no documentation of origin, review, or approval.

• Failure to follow written production and process control procedures as required by 21CFR 211.100.

(Internal) Quality Audits

• Failure to conduct quality audits required by 21 CFR 820.22, and in your procedure QO02, “Audits” to assure your firm is operating in compliance with the regulations.

• Quality audits are inadequate to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.

• We are requesting that you submit to this office, on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment’s manufacturing and quality assurance systems.

• Failure to document the dates and results of quality audits.

To be continued…