Manufacture of drugs

Guidelinesfor Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, Office of Drug Evaluation and Research (HFD-100), FDA, RockviUe, Md., 1987, pp. 3, 4. 

The FDA s Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances makes some speeifie referenees to ehiral drug substanees. The requirements are similar to those in the EU. Elueidation of the... 

The ability to provide accurate and reliable data is central to the role of analytical chemists, not only in areas like the development and manufacture of drugs, food control or drinking water analysis, but also in the field of environmental chemistry, where there is an increasing need for certified laboratories (ISO 9000 standards). The quality of analytical data is a key factor in successfully identifying and monitoring contamination of environmental compartments. In this context, a large collection of methods applied to the routine analysis of prime environmental pollutants has been developed and validated, and adapted in nationally or internationally harmonised protocols (DIN, EPA). Information on method performance generally provides data on specificity, accuracy, precision (repeatability and reproducibility), limit of detection, sensitivity, applicability and practicability, as appropriate. 

Federal Food, Drug and Cosmetics Act (FDCA) provides the Food and Drug Administration (FDA) authority to regulate the manufacturing of drugs and pharmaceuticals and the use of packaging and additives in food and cosmetics. 

Personnel engaged in GMP manufacturing of drug products are required to be formally trained in quality practices. They are only assigned to tasks for which they have been trained. This is to guarantee that drugs are manufactured by qualified personnel and quality is built into each step of the manufacturing process. 

For the manufacture of drug products, certain processes have to be performed in clean areas. Specifications for environmental airborne par-... 

Manufacturing of drugs, whether the API or finished dosage form, is required to comply with GMP regulations (see Chapter 9). Figure 10.1 shows the implementation of GMP concepts in drug manufacture. 

Prospective harmonization is particularly successful when dealing with biotechnology-derived products [14,15] because only a few manufacturers are involved. There should be no reason for the pharmacopoeias to arrive at different standards proposed for any particular medicine. This is in stark contrast to the situation where many manufacturers of drugs are no longer covered by patent protection. There is no possibility of harmonization of the some 4000 monographs for individual substances and preparations. 

The majority of Governments comply with their treaty obligations and provide the Board with information on seizures of substances used in the illicit manufacture of drugs. In addition, in accordance with Economic and Social Council resolution 1995/20 of 24 July 1995, most States and territories are providing voluntary information on licit trade in, uses of and requirements in scheduled substances, which is essential for preventing diversion. All the major... 

Examination of action taken by Governments and the Board to detect and prevent diversion of precursors for the illicit manufacture of drugs... 

Governments are therefore urged, where appropriate, to exercise appropriate controls over such substances in order to ensure that traffickers are not able to make use of mixtures in the illicit manufacture of drugs. 

Seizures of all of the substances in Tables I and II, with the exception of isosafrole and piperonal, both substances used in the illicit manufacture of MDMA (Ecstasy), have been reported for 2003 by 43 Governments, and seizures of 65 non-controlled chemicals have been reported by 22 Governments. As the information relating to non-controlled substances is essential to the revision of the adequacy and propriety of the current lists of substances in Tables I and II of the 1988 Convention, as well as to the maintenance of the limited international special surveillance list of non-scheduled substances, the Board encourages Governments to ensure that mechanisms are in place to record information on all chemicals found to be used in the illicit manufacture of drugs and not only those scheduled under the 1988 Convention. 

The tables include data on domestic seizures and on seizures effected at the point of entry or exit. They do not include reported seizures of substances where it is known that they were not intended for the illicit manufacture of drugs (for example, seizures effected because of administrative shortcomings, or seizures of ephedrine/pseudoephedrine preparations to be used as stimulants). Stopped shipments are also not included. The information may include data not submitted by Governments on form D. 

The Parties shall use their best endeavours to apply to substances which do not fall under this Convention, but which may be used in the illicit manufacture of drugs, such measures of supervision as may be practicable. ... 

---