Process validation process

Following processes to be validated are

– Aseptic filling processes
– Sterilization processes
– Clean room ambient conditions
– Sterile packaging sealing processes
– Lyophilization process
– Heat treating processes
– Plating processes
– Plastic injection molding processes
– Routine end-product tests have insufficient sensitivity to verify the desired safety and efficacy of the finished devices
– Clinical or destructive testing would be required to show that the manufacturing process has produced the desired result or product
– Routine end-product tests do not reveal all variations in safety and efficacy that may occur in the finished devices
– The process capability is unknown, or it is suspected that the process is barely capable of meeting the device specifications

Process Validation steps

1. Determine the need to validate
2. Determine what to validate (IQ, OQ, or PQ)
3. Write a validation protocol
4. Conduct the protocol and collect the data
5. Analyze the data
6. Improve the process, as warranted, based on the data and analysis
7. Prepare a report
8. Maintain the documentation as a quality record