FDA cGMP violations and Quality assurance has took failure decisions

With this article we would like to share you about 2 of 4 FDA cGMP violations which teach about cGMP from where non GMP activities went. (Click here to read about observation 1 of 4) 

Learn observation 2: The inspector has identified that the API product has been released without testing mandatory tests.

It was routed through Change control Whereas Quality Assurance department has been took decision to release API to market without completing mandatory tests. The QA has took decision based upon previous test history. 

The Change control has been took to address breakdown of testing machine, and the pending tests for batch X to batch Y shall be tested once testing machine back its actual condition. 

However the firm failures do accomplish pending testing operations as investigator has been verified and not found there is no test results updated in certificate of analysis documentation this influence to integrity failure of Quality Assurance to verify the activities and documentation and resulted the violations to cGMP.

The Observations as below.

2.    Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP, and meet established specifications for quality and purity.

Investigator found that United States Pharmacopeia (USP) API were released without testing by ultraviolet (UV) spectrometry for identity.

Your change control form stated, “Batches shall be released on conditional basis and as soon as UV maintenance issue rectified analysis shall be performed for identification and (b)(4) content.”

certificate of analysis states “UV & (b)(4) result shall be updated.” However, our inspection found that identity and (b)(4) testing was never performed. It is unacceptable to distribute batches without conducting the required quality control tests to assure your API meets its quality attributes.

In your response, you state that your UV spectrophotometer broke down. Your quality department felt the quality of the released batches was adequate because other required release tests were passed, high performance liquid chromatography (HPLC) testing was done, and trend data for (b)(4) was satisfactory. Your response is inadequate.

In response to this letter, provide:

·         A detailed summary of all batches released without all required testing. Identify the tests you did not perform, and how you plan to ensure that released products meet specifications.

·         A list of the improvements you have made to your batch release process to ensure that you do not release future batches before all required tests are completed.

·         Improvements made to your existing system to ensure required equipment is available to conduct testing for batch release.

·         A summary of your method validation study to support the use of HPLC in lieu of the compendial method for determining identity.

By our next articles as below.

observation-3 (Failure to ensure all production deviations are reported)

observation-4 (Failure to ensure that test procedures are scientifically sound) 

Click Here for FDA Warning Letter

Also read Observation 1: Cleaning of equipment's and how to write regulatory response 

Also read about Effective CAPA SYSTEM

Author: Mahender Nagaraju

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