The pharmaceutical industry is one of the most intensely regulated industries. One regulatory requirement is to validate the process to ensure that the process consistently deliver quality products. Since 2011 the FDA recommends a lifecycle approach to process validation, including three stages: Stage 1-Process Design, Stage 2-Process Performance Qualification (PPQ), and Stage 3-Continued Process Verification over the lifecycle of the process and product. In Stage 2, the manufacturing process is upscaled from pilot/clinical trial scale to commercial scale. The produced PPQ batches/conformance lots are evaluated to determine whether the products that have the required high quality, safety, and efficacy and are comparable with the clinical trial material.
Progress-PME employees are very experienced along the 3 validation stages in a lifecycle of a drug as defined by the FDA. They can support you to produce drug products which fulfil all quality requirements during the whole lifecycle of the product. With their Stage 2 Process qualification expertise as well as their manufacturing process upscaling expertise in combination with their GxP knowledge can support you to perform the process validation of your manufacturing process as required by the regulatory agencies.