The validation of the manufacturing processes constitutes the ultimate purpose of any validation policy as it is the fundamental requirement of the pharmaceutical Good Manufacturing Practices (cGMP) to prove suitable control of the process and consistent and reproducible quality of the product.
The concept of validation has evolved dramatically over the last 20 years: Process Validation today should be understood, beyond the traditional ‘three consecutive batches’, as the documented evidence of a sound, scientific knowledge and process understanding, considering the product quality attributes, the process critical parameters, the embedded risks for the product and how these are prevented, throughout the complete product Life Cycle.
Process knowledge and understanding can only be built in during the development phases of the product Life Cycle (Process Design), building the quality through the appropriate activities at the laboratory, pilot plant, scale-up and production stages and documenting these activities and conclusions following good documentation practices.
Since FDA 2002 ‘Risk-based approach’ initiative to the present and the issuance of the latest FDA guideline (2011), EMA (2014) and the updating of Annex 15 of EU GMP, significant changes have been introduced in the interpretation and expectations of process validation. Indeed, the ‘three stages’ approach by the FDA, the consideration of the continued process verification or on-going process verification and the relevance given to the statistical treatment of process and product data is changing dramatically methodologies and approaches to tackle this essential GMP requirement
At TDV we have a wide international experience on Process Validation, endorsed by many successful projects, audits and inspections to our customers by the European authorities and the US FDA (Pre-Approval and Regular Inspections).
- Process Validation:
- API manufacturing
- Solid and liquid dosage forms manufacturing and packaging
- Sterile and Aseptic Manufacturing
- Biotechnology processes
- On-going process verification programs
- Diagnostics reagents manufacturing
- Herbal drug preparation
- Optimization and pre-qualification of manufacturing processes
- Technology transfer: from R&D to commercial scale
- Cleaning and sterilization validation
- Supply chain related processes
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