What are the quality controls and statistical process controls?
This is highly dependent on the product or service and may be defined with the customer. Some critical aspects are as follows: • product release criteria form the basis of specifications and the Certificate of Analysis for each product that is currently manufactured; • product manufacturing and batch record processes are in place with appropriate quality controls for testing and release post-manufacturing • for new client products processes, including product release criteria, are usually partially defined at the beginning of development then become more refined as the processes become known; • the parameters of product performance are clarified by comparative testing of replicate but separate lots of the product, to include repeat sample testing and follow-on stability testing to assess shelf life and other criteria; and • for services work replicate sample testing and statistical considerations are summarized and approved as part of the contract development and deliverables. BACK • W
