Control of medicines

The approaches to analytical procedures uncertainty prognosis are developed. The correctness of these approaches is confirmed in 3rd and 4th rounds of pharmaceutical laboratories inter-laboratory testing ( Phamia-Test program of State Inspection for Quality Control of Medicines, Ministry of Health of Ukraine). 

The EP is published under the direction of the Council of Europe and is available in English and French. It is the result of obligations undertaken in a convention set up under the auspices of the Council of Europe and signed by 19 countries. The EP has two important aspects, the unification of national pharmacopoeia and the unification of methods of quality control of medicines. 

Because of the rising future demands and delays in licensing, the Minister of Health announced on 11 March 1987 that he had commissioned a study of the control of medicines in the United Kingdom. The terms of reference were ... 

Penn RG. The state control of medicines the first 3000 years. Br J Clin Pharmacol 1979 8 293-305. 

Good manufacturing practice is that part of the quality management system (QMS) that is concerned with the production and quality control of medicinal products (drugs) for human and veterinary use. It includes documentation, personnel training, facility, equipment, and process controls for the manufacture of pharmaceuticals. 

Carstensen JT. Stability of solid dosage forms. In Timoney DA, ed. Progress in the Quality Control of Medicines. Chapter 5 Elsevier Biomedical Press, 1981 97-112. 

Production on quality control of medicinal products derived from recombinant DNA technology (7/1987)... 

Orr, N. Quality control and pharmaceutics of uniformity of content of medicines containing potent drugs with special reference to tablets. In Progress in the Quality Control of Medicines, Deasy, P.B., Timoney, R.F., Eds. Elsevier Press Amsterdam, 1981 193-256. 

The QCAC advises the Ministry of Health on matters pertaining to GMP and quality control of medicinal products. This committee is chaired by a competent and renowned academic. The committee is composed of chemists from academic and private laboratories and quality control personnel from the industry. 

OTHER RELATED CONTROLS Advertisements Control of Medicinal Products... 

The Medicines Act Information Letter is a bimonthly updating service on matters relating to the licensing and control of medicines, and is published on alternate months. MAIL regularly provides statistics on MCA assessment and licensing times for MAs and variations, and also includes a list of contact points. 

The joint subcommittee of the English and Scottish Standing Medical Advisory Committees, under the chairmanship of Lord Cohen of Birkenhead, made recommendations regarding future legislation for the control of medicines, in addition to the immediate establishment of the Committee on Safety of Drugs, which came into operation in 1963 and whose function was to review the evidence on new drugs and offer advice on their safety. The Committee consisted of a panel of independent experts from various fields of pharmacy, pathology and so on. The Committee was serviced by a professional secretariat of pharmacists and medical officers, who undertook the assessment of the submissions and presented these to the committee and various subcommittees. 

In the United Kingdom, regulation is derived from the Medicines Act of 1968, which provides a comprehensive system of licensing affecting most aspects of the sale of medicinal products. It also contains provisions on related matters, such as pharmacovigilance and the requirements for the reporting of adverse events (AEs). The Medicines Act encompasses measures contained in European Community Directives, including the first on the control of medicines, introduced in 1965. The Medicines Act led to the creation of various... 

International Chemical Reference Substances (ICRS) are established upon the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quahty control of medicines published in The International Pharmacopoeia or proposed in draft monographs. The International Chemical Reference Substances are mainly intended to be used as primary standards to calibrate secondary standards. 

Because of the increasing future demands and delays in licensing, the Minister of Health, Mr Newton, announced on 11 March 1987 that he had commissioned a study of the control of medicines in the UK. The terms of reference were To examine the issues for DHSS arising from continued increase in license applications and other work under the Medicines Act and to recommend ways of dealing expeditiously with this work, while maintaining adequate standards for the safety, efficacy and quality of human medicines in the UK . 

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