Section 820.75 of the FDA Code of Federal Regulations Title 21 defines the Process Validation requirements of 21CFR820.70 – Production and Process Controls.
The Process Validation requirements include:
- Validation of the production process is required if the final results of a process cannot be verified by subsequent inspection or testing.
- The validation testing and results, the date and signature of the personnel approving and executing the validation testing, and any equipment that is being validated or used during the validation will be documented per the manufacturer’s Document Control procedures.
- The manufacturer must generate and maintain work instructions, or standard operating procedures for the monitoring and control of the process parameters for each validated process.
- The manufacturer will ensure that the validated processes are performed only by qualified personnel.
- The monitoring and control methods, data, date performed, personnel performing the process, any equipment that is being validated or used during the validation must be documented per the manufacturer’s Document Control procedures for the validated processes.
- If changes or process deviations occur, the process will be reviewed, and revalidated (as necessary). All reviews and revalidation testing must be documented per the manufacturer’s Document Control procedures.
A knowledgeable Mesa representative is available to assist with any questions you may have. Please contact us for more information on the FDA Code of Federal Regulations Title 21, Section 820.75, and to learn how Mesa can help at your facility.