Hi everyone, I need to know if it is required by FDA to audit the Quality System every year, or is what you state in your Standard Operating Procedure for Internal Audits?

Hi everyone, I need to know if it is required by FDA to audit the Quality System every year, or is what you state in your Standard Operating Procedure for Internal Audits?The answer is yes:tg:. From http://www.fda.gov/cdrh/qsr/17audit.html


Audit Schedule
Manufacturers are responsible for deciding the frequency of audits. The frequency should depend upon previous audit findings, any indications of problems, and known stability of the manufacturing process. If an audit reveals no problems, the audit intervals could be lengthened -- if problems are identified, audits may need to be conducted more often. Audits are usually conducted every 6 to 12 months, but should not exceed 12 months. Some companies split their audit into parts, and perform one or more parts per month or quarter, or audit one or more operations per month or quarter. This approach is valuable because it tends to direct attention toward problems that can be resolved within reasonable time limits and existing budgets. However, such segmented audits may fail to identify company-wide problems. Thus, reviewers of segmented audit reports should look for indications of company-wide problems.

PS I hope that Jane does not object me cutting and pasting from the FDA website....:notme:

The regulation does not stipulate the frequency of the audits.Sec. 820.22 Quality audit.

Each manufacturer shall establish procedures for quality audits and
conduct such audits to assure that the quality system is in compliance
with the established quality system requirements and to determine the
effectiveness of the quality system. Quality 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.

I agree with Al's post, 21 CFR 820 does not require annual internal audits, however, both the QSR Manual section copied in Sydney's post and the FDA's Guide to Inspections of Quality Systems recommend that the time between quality audits not exceed a 12-month period.

Just an interesting note, the word 'audit' does not appear in the drug GMPs - 21CFR 211. Seems the FDA is not that concerned with the details of the quality system for drug firms.

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant.

I want to comment about internal audits. 21 CFR 820.22 does not specifically state when audits are to be performed. This is because it is up to the individual firm to develop an audit procedure based on various internal criteria.

Of course 21 CFR 820 is not the sole document. The preamble to the QSR is also part of the regulation. Additionally, FDA documents (not necessarily FDA regulations), such as the QSR manual, the QSIT manual, and the compliance program 7382.845, note FDA's current thought processes. Various FDA documents address annual internal audits. This does not mean that a firm has to have one annual audit, but can have several mini audits during the year. However, the total annual audit scheme has to cover all applicable sections of the QSR.

Internal audits are crucial, because if FDA notes major deviations, especially repeat deviations after a re-inspection, then this shows that the prior year's internal audit was ineffective. As such, there will be an additional deviation- an ineffective audit.

Remember, QS means quality system. As such, each section is inter-twined with other sections. This means, at a minimum, CAPA's, management reviews, and internal audits are connected with each other.

Geochaz is correct. I am also a former FDA auditor. FDA "recommends" that the QS be audited at least once every 12 months, but does not 'require' it in the regulations. FDA does expect your company to audit with sufficient frequency, so if you are finding major issues in the same areas, your audit frequency in those areas should be increased.