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The Company of Decade - the Russian pharmaceutical products manufacturer

GMP Standards

All the pharmaceutical producing subsidiaries of OJSC Pharmstandard have implemented a fully functioning and continuously evolving quality control management. The current quality control management system has been developed and implemented in strict compliance to the requirements of the EU Directive 2003/94/EU, Russian manufacturing standards GOST R 52249–2009 (GMP) ‘Rules for the Production and Quality Control of Pharmaceuticals ' and GOST R ISO 9001–2008 (ISO 9001–2008) ‘Quality Management System. Requirements’.

In 2011, the Body responsible for certification of management systems inspected the following subsidiaries of the Company: OJSC «Pharmstandard-UfaVITA», 27–28 April 2011; OJSC «Pharmstandard-Leksredstva», 17 May 2011 and OJSC «Pharmstandard-Tomskhimfarm», 24 May 2011 and had their current certificates validated confirming their compliance with the requirements of the national standards of the Russian Federation GOST R ISO 9001–2008 (ISO 9001–2008) «Quality Management System. Requirements» and GOST R 52249–2009 (GMP) «Rules for the Production and Quality Control of Pharmaceutical Products».

This aspiration to comply with the standards of GMP is the prerequisite for our extending co-operation with companies in the EU and worldwide. In December 2011, seven production lines of OJSC Pharmstandard-Leksredstva received certificates of conformity with the standards of the EU Good Manufacturing Practice (EU GMP) outlined in the Directive 2003/94/EU. These EU GMP certificates are available to see in the EudraGMP database at the following link http://eudragmp.emea.europa.eu/

The main directions and objectives of the subsidiaries of OJSC Pharmstandard as regards the issues of quality, which have been officially adopted by the management, are reflected in the internal Quality Policy.

The system of quality management includes a set of measures which, applied systematically, ensures that the manufactured goods are compliant with the established normative requirements regarding their quality and possess the necessary consumer properties (quality, efficacy, safety). Quality of pharmaceuticals is defined as their conformity with all the registration requirements, production requirements (technology, production sites, personnel) and specification data. It is the main objective of the management of OJSC Pharmstandard to ensure that the manufactured pharmaceuticals comply with the quality requirements.

OJSC Pharmstandard has a system of document keeping which complies with the requirements of GMP, ISO. The documents of the quality management system contain principles and the mechanism of realisation of such principles in accordance with each chapter of Good Manufacturing Practice dedicated to a specific aspect of quality.

The objective of such a system is a timely provision to each subdivision of the enterprises of necessary up-to-date documentation which would enable them to organise the production processes in all their complexity and result in the production of high-quality, effective and safe pharmaceuticals.
All the measures concerning production, control and licensing are contained in such documentation.

All specialists working for the Company undertake compulsory GMP studies in leading Russian establishments which specialise in teaching pharmaceutical professionals the requirements of expedient production and control of pharmaceuticals on the basis of the best international practices. Pharmstandard’s continuing success and its leading position in the Russian pharmaceutical market are secured by its highly skilled and competent personnel.
One of the elements of the quality management system is the quality service which has been set up at the enterprises of OJSC Pharmstandard. Control over the quality of raw materials and supplies, intermediate and bulk products and finished products is carried out by highly skilled specialists of the quality service according to the authorised methods and using modern high-value testing equipment. Only those raw materials and supplies are admitted for the production process which have passed the acceptance test and received permission to be used in production. Only those raw and other materials which have passed the initial test procedures and have been certified are allowed to be used for the manufacture of pharmaceutical products. During the production process the following monitoring procedures are carried out: monitoring of the main parameters of manufacturing processes, monitoring of the environmental parameters (microbiological air control, control of equipment, clothes, personnel’s hands etc.) and control of the quality of intermediate and bulk products. Finished products are only ready for sale when a representative of the quality control management confirms in writing that each batch of the finished product has been produced and undergone quality control in compliance with the requirements of the master file.

The quality service also undertakes investigation regarding product quality claims and complaints. Each claim and complaint is registered and investigated in accordance with the established procedures. On the basis of the investigation conclusions a plan of rectification and prevention measures is drawn up. The performance of such a plan is meticulously monitored, and the efficacy and performance of the undertaken rectifying and preventative measures is evaluated.
All the new processes, equipment, rooms, methods and systems are validated. Validation is an element of the system of quality control management and is an integral part of the entire process of development of a pharmaceutical product and the technology of its manufacturing.

Validation is a set of measures which result in documented confirmation that a certain established manufacturing procedure, certain control measures relating to the object of validation lead to a guaranteed expected quality of pharmaceutical product.

A system of internal audits which has been developed and implemented at the enterprises of the Company, is successfully functioning. Such audits are carried out by a group of competent specialists working at the enterprises.

The objective of the external and internal audits of manufacturers/suppliers of raw materials and supplies, of third-party contractors is verification of compliance of the manufacturing processes management with the requirements of GMP, ISO and with those of OJSC Pharmstandard as well as of compliance of product and services supply with a guaranteed, proper standard. The purpose of internal audits (self-audits) at the enterprises of OJSC Pharmstandard is to evaluate efficacy of the quality control management, to improve its performance and to determine further actions aimed at developing and improving it. External and internal audits are performed in accordance with annually drawn-up schedules and at regular intervals.

All the enterprises of OJSC Pharmstandard are subject to regular external audits both by the state bodies of the Russian Federation (Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation) and by independent European and Russian auditors.
Below is the list of certificates of compliance issued to OJSC Pharmstandard subsidiaries:

OJSC Pharmstandrd-Leksredstva:

  • Certificate of compliance with EU GMP (Good Manufacturing Practice) outlined in Directive 2003/94/EU (1), ZVA/LV/2012/006H of 10.02.2012, valid till 08.12.2014.
  • Certificate of compliance with GOST R 52249–2009 (GMP) ‘Rules for the Production and Quality Control of Pharmaceuticals’ RU.04-DG24.4–027 of 27.05.2010, valid till 27.05.2013.
  • Certificate of compliance with GOST R ISO 9001–2008 (ISO 9001:2008) ‘Quality Management System. Requirements’ ROSS RU.11.00589 of 27.05.2010, valid until 27.05.2013
  • SGS certificate of compliance with ISO 9001–2008 «Development and Manufacture of Pharmaceutical Products» 10/1354 of 01.06.2010, valid till 31.05.2013

OJSC Pharmstandard-UfaVITA:

  • Certificate of compliance with GOST R 52249–2009 (GMP) ‘Rules for the Production and Quality Control of Pharmaceuticals’ RU.04-DG24.4–029 of 03.06.2010, valid till 03.06.2013
  • Certificate of compliance with GOST R ISO 9001–2008 (ISO 9001:2008) ‘Quality Management System. Requirements’ RU.11.00594 of 03.06.2010, valid till 03.06.2013
  • SGS certificate of compliance with ISO 9001–2008 «Development and Manufacture of Pharmaceutical Products» 10/1356 of 11.06.2010, valid till 10.06.2013

OJSC Pharmstandard-Tomskhimfarm:

  • Certificate of compliance with GOST R 52249–2009 (GMP) ‘Rules for the Production and Quality Control of Pharmaceuticals’ RU.04-DG24.4–028 of 03.06.2010, valid till 03.06.2013
  • Certificate of compliance with GOST R ISO 9001–2008 (ISO 9001:2008) ‘Quality Management System. Requirements’ RU.11.00593 of 03.06.2010, valid till 03.06.2013
  • Certificate of compliance of pharmaceutical immunobiological product Imudon, tablets for dissolution in the mouth, with the normative requirements No. 0594517 f 29.02.2012 for pharmaceutical products manufactured before 01.08.2012
  • SGS certificate of compliance with ISO 9001–2008 «Development and Manufacture of Pharmaceutical Products» 10/1355 of 07.06.2010, valid till 06.06.2013

OJSC Tyumen Plant of Medical Equipment and Tools:

  • Certificate of compliance with the standard EN ISO 13485 (ISO 13485:2003) Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes) No. 4115.48.01/0 of 20.10.2008, valid till 20.10.2013
  • EU Certificate of compliance with the requirement of Annex V, section 3 of Directive 93/42/EEC (concerning medical devices, dated 14 June 1993) with respect to full quality assurance system, No. 4115.07.01/0 of 13.11.2008, valid till 13.11.2013
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