Good manufacturing practice control records

Quality Control Records. Accurate quality control records are of utmost importance and may be required by law, as in the pharmaceutical industry. A few years ago, mandatory Good Manufacturing Practices were proposed for the cosmetic industry. Although the proposal was later dropped, many manufacturers go by the rules worked out at that time for laboratory testing and record keeping. The food industry also requires extensive testing and record keeping. 

Good manufacturing practice regulations identify what controls must be in place and adhered to in order to be in compliance, but do not provide instruction on how to implement these controls. The methods used to ensure the product meets its defined requirements are the responsibility of the pharmaceutical manufacturer, who must be prepared to demonstrate GMP compliance with validated systems and formal records. 

The explicit control of named contaminants requires that the possibility of their presence has been recognised and recorded in, for example, a negative list. Almost by definition, the majority of contaminants are not of this nature. Analysis for contaminants in packaging materials and for any migration of same, is difficult and almost open-ended. For this reason, much emphasis is needed on Good Manufacturing Practice and in record-keeping. 

The issues involved in the necessary record keeping. Good manufacturing practice (GMP) and regulatory control that are associated with a seeded process in the pharmaceutical industry are sometimes cited as reasons not to seed. In response to an article endorsing this premise (Pessler 1997), the following rebuttal by C.B. Rosas (personal communication) summarizes his and the authors views on this topic. 

FDA (Food and Drug Administration). 1996. Current good manufacturing practice, quality control procedures, quality factors, notification requirements, and records and reports, for the production of infant formula Proposed rule. Fed Regist 61 36153-36219. 

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