Process analytical technology current Good Manufacturing

Validation and process analytical technology (PAT) require that we find and control the primary sources of product and process variation. Not many people realize that the current good manufacturing practice contain the words validation and variability in the same sentence. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (1). 

Exposure of all products used in foods and food processing to foreign material contamination must be prevented. If objectionable impurities from any source, other than those covered by FCC requirements, are suspected to be present, good manufacturing practice requires the manufacturer to ensure that the substance is suitable for its intended applications as a food chemical by applying additional tests and limits. Current analytical technology should be applied wherever possible. 

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