Process Validation applies to the production of pharmaceuticals and intermediate products as well as the manufacture of medical devices. Per the FDA Process Validation Guidance, “process validation is defined as the collection and evaluation of data, from the process design stage 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' team of process validation experts can assist with design of process validation methodologies as well as development and execution of process validation protocols in both pharmaceutical and medical device
Cleaning Validation is just as important as process validation when it comes to the safety and continued compliance of any manufacturing firm. MEDVACON has the experience and knowledge to help our clients develop and verify that their manufacturing equipment consistently removes process soils before the next manufacturing run to ensure clean, uncontaminated equipment. Our highly trained staff is experienced in developing and executing cleaning development and cleaning validation master plans and protocols in line with current industry standards. We provide a hands-on approach to help guide our clients through the details of establishing a cleaning master plan, setting residue acceptance criteria, preparing a comprehensive sampling plan, and validating and utilizing appropriate qualified analytical methods with sufficient sensitivity for those unique processes and equipment.
A Pharmaceutical client engaged a senior MEDVACON expert to oversee the Process & Cleaning Validation Group and manage all process and cleaning validation activities for the site. Additional MEDVACON experts were brought in to handle all aspects of 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 process validation samples and cleaning swabs. to where they are.
A Pharmaceutical client engaged MEDVACON to travel to their contact manufacturing site to troubleshoot a pharmaceutical process that was producing unwanted particulates in an aseptic process. MEDVACON identified the issue in the process and developed a technical report with a solution. The fix was implemented and production was able to resume averting costly rejected batches and production delays.
A biopharmaceutical company specializing in applying deuterium chemistry to known molecules to create novel therapies with the potential for improved safety and efficacy profiles engaged MEDVACON to oversee the process validation activities at their contract manufacturer. In addition to many other activities, MEDVACON reviewed the process validation protocols and oversaw the entire validation process to ensure compliance. The product received FDA approval and MEDVACON remains engaged overseeing CMC and Clinical Supply activities.
MEDVACON was engaged by our medical device client to provide technical and regulatory assistance in assessing the impact that a small facility fire had to one manufacturing area used for the production of medical devices for multiple clients. MEDVACON provided initial remediation plan guidance and assisted the Client in developing customer specific remediation plans including cleaning and component disposition. MEDVACON also participated on client conference calls providing medical device compliance expertise. MEDVACON was additionally engaged to develop a overall Cleaning Validation Plan for the company.