ABSTRACT
Validation evolved in the United States during the 1970s when large-volume parenterals (LVP) had to be recalled because of p roduct contam ination an d /o r lack of sterility. It became evident that finished-product testing was not sufficient to assess the qual ity and sterility o f parenteral products. Production and control procedures had to to be established to docum ent that systems and procedures were under control. The term validation was used to describe the establishment o f “docum ented evidence” that m an ufacturing processes of parenteral dosage forms consistently met defined quality characteristics. The initial validation concept focused on the sterilization process, aseptic operations and the process used to generate water in the preparation o f the product. But it was soon recognized that other critical systems associated with the m anufacturing process (e.g., heating, ventilation and air
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conditioning and m edia like compressed air and nitrogen) had to be included in the concept as well.
