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:
The FDA Expects:
We offer our clients an FDA Compliant, comprehensive CAPA - Deviation - Non-Conformance Investigation and Closeout solution.
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.
MEDVACON was engaged by a Contract Manufacturer to assist with investigation and close out of self-reported open deviations and CAPA's in several functional areas within the manufacturing site. MEDVACON deployed a team and assigned a lead to each functional area to drive the investigations and closeouts to completion. The MEDVACON team leads worked closely with each other and client leadership and were able to identify common root causes that impacted various functional areas. Corrective actions were put in place to prevent future occurrences. The MEDVACON team members followed this approach: conducted root cause analysis, to determine why the deviation occurred; conducted an impact assessment, to determine the (possible) consequences of the deviation; defined 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.