Sunday, August 14, 2011

The Top Ten Warning Letter Observations about the Pharmaceutical Quality Unit


The responsibilities of the Pharmaceutical Quality Unit are defined in the CGMPs and practices clarified in guidance documents. (See The QA Pharm, August 7, 2011.)

Just as it is with any legal matter, case histories help us understand how the law is applied in specific situations. That’s the reason it is a good practice to regularly review Warning Letters on the FDA website.

Here’s my condensed list of issues the FDA has had with the Quality Unit as seen in Warning letter observations.

This is the list you don’t want to be on.

1.    QU failed to establish a system to ensure that…[fill in the blank for anything that went wrong]

2.    QU failed to document the responsibilities applicable to the quality control unit in procedures, and fully perform these responsibilities.

3.    The personnel performing laboratory tests… were not trained.

4.    QU failed to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.

5.    QU failed to fully perform and/or document the review of batch production records to determine compliance with all established, approved written procedures before a batch is released or distributed.

6.    QU failed to ensure that all tests are in conformance with the established specifications and that these are met prior to the release of drug products for distribution.

7.    QU did not review production records to assure that no errors had occurred or, if errors had occurred, that they had been fully investigated, conclusions made and followed-up.

8.    QU failed to investigate complaints involving the possible failure of a drug product to meet any of its specifications.

9.    Failure to submit NDA-Field Alert Reports (FARs) within three (3) working days of receipt of information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug products

10.  And my personal favorite…a designated QU has not been established.


John Snyder
The QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.


Contact us at john@john-snyder.com.

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