ABSTRACT
The documentation prepared during the production and testing of pharmaceutical products is the most complex and extensive of any industry that produces a consumer product. Furthermore, the production standards for parenteral drugs are the most demanding of any dosage form because of the need to avoid contamination, be it chemical, particulate, or biological. The records generated during production of any drug are exceedingly important because it is by the completeness and accuracy of various documents that the true quality of the product is determined. The need for accuracy of records has been reconfirmed since 1989 by FDA investigation of batch authenticity conducted at many firms to ascertain reliability of statements made in new drug applications.
