This article begins by describing two incidents of large volume parenteral (LVP) contamination occurring in the United States in the early 1970's. Between 2,000 and 8,000 patients became septicemic during the first incident, and it was estimated that 10% of these infected patients eventually died. US FDA and CDC investigated both incidents and in 1976, FDA issued draft regulations to control the production and testing of LVPs.
The concept and origins of process validation can be attributed to this draft document, a document that was later withdrawn by FDA.
The article continues by describing the methods for qualifying and validating HVAC systems and cleanrooms. Next to human operators, HVAC is the second largest source of product contamination, so qualification and validation of these systems are essential.
This article appeared in the 30th anniversary edition of Pharmaceutical Technology magazine.