Process quality​

Manufacturing methods and processes to be used should be developed, equipment selected, and processes and methods qualified. For all significant processes such as welding, molding, lyophilizing, sterilizing, and packaging/sealing where the output cannot be fully verified, the qualification should include a full validation of the processes. 

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Production specifications and methods employed in manufacturing should result in standard in-process and finished products without excessive sorting or reprocessing.​

Inspection and test methods should be developed that will adequately monitor product characteristics to make certain these are within the acceptable specifications. These methods should be developed, evaluated, validated where necessary, and documented during the product and process development phase. 

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The methods should be implemented at the beginning of routine production. Any adverse effects the manufacturing processes, manufacturing materials, or equipment may have on device safety and performance should be identified.​