Good manufacturing practice regulatory controls

The below definition needs some explanatory words (Box 5). A first aspect to consider is that counterfeiting implies the intention to cheat those who receive the medicine - either in the distribution chain or as patients. This is important because it permits to make necessary distinction between counterfeit medicines and sub-standard medicines. Counterfeit medicines are sub-standard because they are manufactured and distributed out of control and their composition is unpredictable. On the other hand, not all sub-standard medicines are counterfeits. Substandard products are genuine products, manufactured by officially licensed manufacturers, which do not meet quality specification set for them. All substandard products are manufactured without compliance with Good Manufacturing Practices (GMP) and other regulatory requirements established by the competent national regulatory authorities in order to ensure that efficacy and safety of medicines is not affected by quality problems. 

Environmental control in drug manufacturing facilities has drawn increased attention from the FDA and other regulatory authorities in the 1990s. Section 46 of the U.S. Code of Federal Regulation for Good Manufacturing Practice states that ... 

There are no formal mutual recognition agreements with other national or multinational regulatory bodies in areas such as mcirketing authorizations, good manufacturing practice (GMP) and batch control. 

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. 

The national health and drug regulatory authorities should ensure that all pharmaceutical products subject to their control conform to acceptable standards of safety, efficacy and quality, and that all premises and practices employed in the manufacture, storage and distribution of these products comply with good manufacturing practice (GMP) standards so as to ensure the continued conformity of the products with these requirements until they are delivered to the end-user. 

---