CAPA, Deviation, Complaint Investigation & Closeout
MEDVACON delivers rigorous and comprehensive CAPA, Deviation & Complaint Investigation and Closeout services that are designed to help reduce the overall cost of compliance for Life Sciences organizations. When manufacturing pharmaceutical products, unexpected events can occur, for instance during production, analysis, transport, storage or even during the qualification and/or calibration of equipment. In the pharmaceutical industry these events are called deviations or non-conformances. Deviations could have a negative effect on the quality of the pharmaceutical products and could even result in a recall of the products. Furthermore, these deviations could be an indication that the quality system is functioning sub-optimally.
For these reasons, it is of the utmost importance to investigate these deviations. In such an investigation the following aspects are essential:
- Root cause analysis, to determine why the deviation occurred.
- Impact assessment, to determine the (possible) consequences of the deviation
- Define corrective and preventive actions (CAPA), to be sure that correct actions were taken to immediately reduce the impact of the deviation, and to prevent the deviation from re-occurring.
The FDA Expects
- Quality Systems staff are effectively integrated into manufacturing and involved in non-conformance investigations.
- The investigation, conclusion and follow-up must be documented
- Any deviation from the written procedures recorded and justified.
- Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. (211.192)
- The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow up. (211.192)
We offer our clients an FDA Compliant, comprehensive CAPA – Deviation – Non-Conformance Investigation and Closeout solution.
Aseptic Combination Product Manufacturing Client
MEDVACON was engaged by an Aseptic Combination Product client to conduct investigations into deviations and non-conformance’s in the aseptic manufacturing suites used to produce the combination product. MEDVACON deployed a team of experts to conduct the investigations and assist this client in meeting stringent FDA commitment timelines. In performing these activities MEDVACON was engaged by the client to resolve a highly technical issue with the combination product mechanical components and successfully identified the issue and implemented a change to the process. While the FDA commitment timelines were met the team remains in place to assist this client with ongoing investigations and closeouts.