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Ministerial Decree No. 916 of 14 June 2013 validating Rules of Good Manufacturing Practice.

Country/Territory
Russian Federation
Document type
Regulation
Date
2013 (2015)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Pests/diseases Hygiene/sanitary procedures Business/industry/corporations Transport/storage Enforcement/compliance Authorization/permit Animal feed/feedstuffs
Geographical area
Arctic, Asia and the Pacific, Black Sea, Caspian Sea, CIS (Commonwealth of Independent States), Eastern Europe, Europe, Europe and Central Asia, North Pacific, North-West Pacific
Abstract

This Ministerial Decree establishes that manufacturer must meet mandatory requirements in order to guarantee the quality of medicines, including veterinary drugs. It shall be applicable also for the manufacturing of antibiotics. Rules of Good Manufacturing Practice, validated by this Ministerial Decree, shall be applicable to sanitary and hygienic safety in the process of manufacturing of medicines, including veterinary drugs, obtained with the use of donor blood or plasma as a raw material. If the regulatory legal acts of the Russian Federation establish special requirements for quality assurance in the production of medicinal products for veterinary use against ectoparasites, such requirements shall be complied with. Biological pharmaceutical substances and medicines must comply with the requirements of regulatory legal acts of the Russian Federation with regard to reducing the risk of transmission of spongiform encephalopathy of animals and latent viruses through medicinal products for medical use and for use in veterinary medicine. Medicinal products against ectoparasites, which are intended for external use, relate to medicinal products for veterinary use and are subject to mandatory licensing for manufacturing thereof. Due to the large volumes of final packaging of some medicinal products for veterinary use (in particular, additives), it is allowed to store samples of each series of products not in their final packaging. However, the manufacturer shall ensure that a sufficient number of archival samples of each series of products are stored in accordance with the requirements of these Regulations. In any case, the packaging for the storage of archival specimens shall be made of the same material as the primary packaging in which the product is marketed. If the manufacturing of immunobiological medicines for veterinary use is located in the same building, other operations with live microorganisms (such as quality control, research and diagnosis) should be carried out in separate isolated rooms. The degree of isolation depends on the pathogenicity of the species and whether it has been classified as exotic. Due to the wide variety of products, the large number of stages in the manufacturing of immunobiological drugs for veterinary use and the nature of biological processes, special attention must be paid to strict compliance with validated technological processes, constant monitoring of all technological stages of production and control during the production process. Particular attention should be paid to the initial raw materials, cultivation environments and use of seed systems.

Full text
Russian
Website
docs.cntd.ru