The FDA defines the validation of production process as followed: production process validation is to develop a written evidence, to provide a high degree of assurance so that the specific production process could meet predetermined specifications and produce qualified products as always. The manufacturers should write the validation plan, pointing out the validation method (and test), and data collection. The purpose of collecting data should be clear and the data must reflect the facts, collected carefully and correctly. Files should point out that the production process have enough repetitions to prove its reproducibility, and it is necessary to determine the accurate measurement of changes in the number of consecutive runs. The inspection conditions in the verification number shall include the upper and lower limits of the production process and the environmental conditions, including the limit range and environmental conditions of the standard operating procedures. In comparison with the theoretical conditions, these upper and lower limit conditions have the greatest chance of producing failure or unqualified product. This condition is known as the worst condition, so called "the most appropriate challenge". Validation file should include evidences of material suitability, manufacture equipment, the performance and the reliability of the system.
In order to ensure the high quality of food and medicine, FDA requires a series of process validation for the product and process life cycle, from the stage of production design and then to intermediate state inspection, to commercial production, collection and evaluation of data. It ensures the sustainable delivery of high-quality products conforming to the specifications. We have experienced team with strong FDA compliance background providing high quality authentication service including Installation Qualification、Operation Qualification, Performance Qualification.
Service contents include:
1. Establish master validation plans to ensure the risk based validation approach to compliant with cGMP
2. Generate validation protocol including IQ/OQ/PQ
3. Perform validation execution and implementation
4. Ensure the Data integrity following FDA regulation
5. Handle exceptions and corrective action to resolve the deviations to avoid any possible compliance issue