Process Validation strengthens the production of pharmaceuticals. intermediate products, and manufacture of medical device manufacturing. Per the FDA Process Validation Guidance, “process validation is defined as the collection and evaluation of data, from process design through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” This entails on-going documentation and assessment of all constituent elements of the process, such as materials, equipment, operations, and environmental conditions. The primary goal is to gain understanding and control of process variation and its effect on process outcome. MEDVACON's team of process validation experts can assist with process validation methodology design and development and execution of process validation protocols in pharmaceutical and medical device environments.
Cleaning Validation is equally important to manufacturing safety and continued compliance. MEDVACON provides our clients with manufacturing equipment cleaning validation process development and verification expertise to ensue uncontaminated equipment conditions during each manufacturing run. Our highly trained staff provides cleaning validation master plans and protocols that outline residue acceptance criteria, provide a comprehensive sampling plan, and define qualified analytical methods with sufficient sensitivity of those unique process and equipment.
MEDVACON's team partnered with a pharmaceutical client to the process and cleaning validation group and facilitate site-wide process and cleaning validation activities.Additional MEDACON experts joined the efforts to support several process and cleaning projects. The MEDVACON team developed the process and cleaning validation protocols and coordinated with manufacturing and quality personnel to pull and analyze validation samples and cleaning swabs.
MEDVACON went onsite to troubleshoot a contract clients pharmaceutical process producing unwanted particulates in an aseptic process. MEDVACON identified the identified the process defect and developed a technical report with a solution. The fix was implemented and production resumed to mitigate costly rejected batches and production delays.
MEDVACON joined a biopharmaceutical company creating novel therapies by applying deuterium chemistry to known molecules. MEDVACON led the process validation processes focused on our contract manufacturer drive for improved safety and efficacy. MEDVACON reviewed the process validation protocols and oversaw the entire validation process to ensure compliance with these product efforts receiving FDA approval. MEDVACON remains a continued trusted partner providing our client CMC and clinical supply support.
MEDVACON collaborated with our medical device client to provide technical and regulatory evaluation following a facility fire contained to the medical device manufacturing area for multiple clients. MEDVACON provided remediation plan quidance and assisted in developing customer-specific cleaning and component disposition. MEDVACON provided medical device compliance expertise and a comprehensive company cleaning validation plan.
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