In GMP Trends Issue Number 1152, we highlight observations related to manpower limitations and the workload associated with the Annual Review Process. This observation comes from an inspected Contract Manufacturer: 

Your Director of Quality stated they do not have enough employees to complete all tasks needed and required of the Quality Unit. These responsibilities include but are not limited to performing Annual Product Reviews, validating procedures, qualifying the… Water System and other equipment, maintenance reviews and documentation

The independence of the quality unit is essential to maintaining good quality practices, but it does not mean Annual Reviews need to be exclusively done by quality professionals. 

At GMP Trends, having the vantage point to look at many 483 observations over a long time, a topic highlighted repeatedly is the need to conduct timely and comprehensive Quality Management Reviews. It’s a big task every year that typically falls on the shoulders of the Quality Unit.  The CFR guidance does not state the products must be reviewed annually exclusively by the Quality Unit. Rather, the guidance states that managers should conduct timely Quality Management Reviews (QMR)

21 CFR 211.180 (e)

Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:

(1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch.

(2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under § 211.192 for each drug product.

The Annual Product Review process is a great way to bring together different personnel from your organization to collaborate on Quality Systems.

“Start early and where possible enlist the help of others with Annual Product Reviews”

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