According to the Code of Federal Regulations (21 CFR 820.22 Quality Audit), Each manufacturer shall establish procedures for quality internal audits and conduct such audits to ensure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality internal audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.
A company recently received the following observation:
….. Quality audits have not been performed.
Specifically, you have failed to implement your Internal Audit Procedures.
a. I inquired about when your firm’s last audit was conducted. Your Vice President retrieved the results of the audit and replied. “Three years ago.” Your firm’s SOP …, “Internal Audit Procedure” states, ….
The firm is not conducting audits as required by their procedures, quality audits were not performed last year or the year before that.
b. Your firm’s SOP …, “Internal Audit Procedure” states … I asked the Vice President (who is listed as the firm’s FDA Management Representative) if he had constructed an audit schedule and he responded. “No.”
For information on what FDA will review during an inspection, refer to FDA Inspection Guide: Management Controls and Guide to Inspections of Medical Device Manufacturers.
To view more observations pertaining to management responsibility, refer to the following GMP Trends® Issues: 1122, 1115, 1113 and 1112.
For more observations pertaining to quality systems, see our new Issue 1125 available today. It also has observations pertaining to manufacturing controls, sterile manufacturing controls and medical devices.
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