The ADB Automation group has a solid record implementing validation principals. Process validation is a vital procedure to commercial manufacturing production as it is a requirement of Good Manufacturing Practices (GMPs) and in the Medical Device manufacturing industry, helps verify that the process meets the 21CFR 211 (Pharmaceuticals) and 21CRF 820 (Medical Devices). As a result, this ensures our client's have a stable and consistent production of quality products through the evaluation and collection of data from design. ABD is extensively experienced in ensuring seamless execution and management of process validation projects. We ensure our process validation follows suitable criteria that comply with regulatory standards in all crucial steps.
The Food and Drug Administration (FDA) defines three vital stages in process validation to determine a successful lifecycle of both the process and the product. Each stage involves activities that help enhance the processes’ safety and legality. The stages are Process Design, Process Qualification and Continued Process Verification:
Commercial processes require a master plan for the validation activities. This design stage details a practical protocol format to validate operational limits and the expected standards factoring into the Master Validation Plan (MVP).
This design stage assesses and guarantees that commercial manufacturing process is reproducible. This developmental stage focuses on the Process Performance Qualification (PPQ) to document, evaluate and report both intended and unintended process performance results.
Continued Process Improvement
This stage provides a recurring verification that assures the production processes continue to remain in a state of control. It can involve rewriting protocols for execution or re-executing existing protocols on an annual basis to recertify a product or process.