FDA has stepped up enforcement of a 1997 rule requiring cGMP facilities to automate production using systems that generate and archive electronic records and produce electronic verification signatures. Only a handful of large pharmaceutical manufacturers are anywhere near compliance with the rule, however, sources say. Fine chemical and smaller pharmaceutical producers will have to make a significant electronic records and signatures produced by controls system as valid documentation. The rule issued eight years later was confusing even to the petitioners, and still requires clarification as the industry scrambles to comply, sources say.
展开▼
