cGMP - How to Avoid FDA Warning Letters regarding 21 CFR 820.75 (Process Validation)?

Process validation is the final mechanism of ensuring production and process control and is required where subsequent inspection and testing cannot fully be verified, for example, if a length of wire will require to be 6 in +/- 0.5in, each length of wire can subsequently be verified by measuring every wire to ensure it conforms to the 6 inches +/- 0.5-inch requirement.

If however each cut wire could not be verified for some reason then a validation to ensure the wire met the requirements with a high level of confidence would be required. Process validation is probably the single most important key to good product quality. If the process validation is conducted correctly it supplies the data to support the metrics for statistical process control which is then used to monitor the validated process and ensure the process is under control, and it also should provide for sampling and inspection criteria which then act as an insurance policy to verify the product is meeting acceptance criteria, with an appropriate level of confidence.

The foundation of manufacturing quality starts with process validation where the process is characterized and process understanding is documented the process is then monitored through statistical process control to ensure the process isn't drifting and it's still capable finally sampling and inspection act as an insurance policy to confirm the product quality is meeting the required acceptance criteria with a specific level of confidence.

Orcanos (www.orcanos.com) provides a complete set of tools that allow manufactures to collect the IQ/OQ/PQ data and QC data completely electronically and provide the needed statistical information about the quality of the product.

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