SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center IV ALL-RUSSIA GMP CONFERENCE Current regulatory requirements for the prevention of cross-contamination in pharmaceutical manufacturing. The “expectations” of inspectors and the practice of inspection.

Cross-documentation prevention requirements Are given in the following guidlines: Order of the Ministry of Industry and Trade of Russia dated June 14, 2013 No. 916 (as amended on December 18, 2015) “On Approval of the Rules of Good Manufacturing Practice”; Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 N 77 “Rules of Good Manufacturing Practices of the Eurasian Economic Union”; General partner: Strategic partners: Official partners: Regional partners:

Requirements of the Order of the Ministry of Industry and Trade of Russia No. 916 “On Approval of the Rules of Good Manufacturing Practice” Manufacturing Chapter 5 Section Prevention of cross-contamination during manufacturing: Manufacturing in dedicated areas; Manufacturing campaigns followed by appropriate cleaning; A proper approach to the design of air treatment and conditioning systems; Providing production facilities with locks and exhaust devices; Application of known effective cleaning methods; General partner: Strategic partners: Official partners: Regional partners:

Requirements of Decision of the ECE Council N 77 “Rules of Good Manufacturing Practice of the Eurasian Economic Union” Manufacturing Chapter 5 Section Prevention of cross-contamination during manufacturing: To assess and control the risk of cross-contamination, a quality risk management process should be used; The results of the quality risk management process should be the basis for determining the level of technical and organizational measures necessary to control the risks of cross-contamination. A detailed description of the technical and organizational measures to prevent cross-contamination is presented in paragraph 5.21. General partner: Strategic partners: Official partners: Regional partners:

Requirements for the organization of manufacturing in dedicated areas In accordance with the requirements of the Order of the Ministry of Industry and Trade of Russia No. 916 “On Approval of the Rules of Good Manufacturing Practice”, manufacturing in the designated areas is mandatory for: Manufacturing of penicillins; Manufacturing of live vaccines; Manufacturing of preparations containing live microorganisms; Manufacturing of biological drugs; Manufacturing of cytotoxins General partner: Strategic partners: Official partners: Regional partners:

Requirements for the organization of manufacturing in dedicated areas In accordance with the requirements of the Decision of the ECE Council N 77 “Rules of Good Manufacturing Practice of the Eurasian Economic Union”, it is necessary to allocate manufacturing if the medicine is a risk: Which cannot be adequately controlled by organizational and (or) technical measures; The scientific findings of a toxicological assessment do not confirm the possibility of proper risk control (for example, highly sensitizing materials with allergenic potential, such as beta-lactams); The corresponding residue limits obtained by toxicological assessment cannot be satisfactorily determined using a validated analytical method; General partner: Strategic partners: Official partners: Regional partners:

Example of the detected non-conformity Paragraph of the rules of order N916 Detailed description of the detected non-conformity 153. (5.18) The risk of contamination of the raw material with other raw material is not excluded. In the central weight room where sampling and weighing of the API for the manufacturing of a lyophilisate for the preparation of a non sex hormone solution for intravenous and intramuscular administration is carried out, the sampling and weighing of sex hormones and API with a cytotoxic effect is carried out. General partner: Strategic partners: Official partners: Regional partners:

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