Menu
The occupational health and safety management system of the company applies to all types of activities of JSC WERTEKS, following the requirements of the ISO* 45001 standard, and provides:
- Safe and favorable working conditions for employees;
- Prevention of industrial injuries and damage to their health;
-
Maintaining and protecting the physical and mental health of workers.
Applies to drug safety control
Compliance with the GVP Rules:
- guarantees the prevention of undesirable consequences of using medical products;
- ensures their use in case of benefits exceeding risks;
- contributes to protecting the health of individual patients and society as a whole.
Pharmacovigilance is a type of activity that is aimed at identifying, evaluating, understanding and preventing undesirable consequences of using medical products.
Applies to the storage, transportation and handling of pharmaceuticals
Compliance with the GDP Rules:
- guarantees the preservation of the quality, safety and effectiveness of drugs on the way from the manufacturer to pharmacies and medical institutions;
- helps to prevent the risk of counterfeit products entering the supply chain.
Applies to the production, storage and sale of biologically active additive
Compliance with the ISO 22000 requirements:
- allows for the release of safe biologically active additive;
- guarantees the compliance of biologically active additive with the legislative requirements for food safety.
ISO 22000 Certificates
The ISO 22000 standard was developed to harmonize requirements for management systems, such as ISO 9001, with HACCP principles: Hazard Analysis and Critical Control Points.
HACCP principles allows to identify risks to food safety, analyze them and find those critical points, where applying measures will minimize the likelihood of deviations from the norm.
Extends to the development, implementation, production, storage and sale of drugs, cosmetics and biologically active additive
Compliance with the ISO 9001 requirements:- guarantees the company's ability to supply products that meet consumer preferences and legal requirements;
- provides continuous improvement to product quality
The ISO 9001 standard is based on a number of concepts and techniques that have been created by leading Western quality experts and provides for:
- process approach to organizing company activities;
- customer focus;
- technological improvement of production, continuous further training of employees of the unit;
- effective and mutually beneficial relations with suppliers, partners and contractors;
- regular assessment of the company's activities to develop and implement measures to improve it, which are primarily aimed at increasing consumer satisfaction;
- competently organized system for responding to customer complaints: elaboration of conclusions, taking effective measures to eliminate deficiencies.
Covers the production and quality control of drug products
Compliance with the GDP Rules:
-
guarantees the conformity of the produced medicine to their intended purpose and the requirements of the registration dossier;
-
minimizes the risk to patients associated with the safety, quality and effectiveness of drugs.
In 2015, WERTEKS became one of the first in Russia to receive the Ministry of Industry and Trade of the Russian Federation certificates of the compliance with GMP requirements for production of pharmaceuticals.
- appropriate conditions in clean rooms and other facilities;
- staff qualifications;
- necessary equipment and its maintenance;
- raw materials, finished products, their storage and transportation;
- methods and instructions, corresponding protocols, records of each series of drugs;
- risk assessment;
- handling claims during the sale of products and the adoption appropriate measures.
Integrated Quality System
The system covers the development, implementation, production, storage and wholesale of pharmaceutical drugs, cosmetics and biologically active additive.
Quality system
Is based on a process approach and risk-oriented thinking following the requirements of national and international standards of GMP, GDP, GVP, ISO 9001, ISO 22000, ISO 45001
System goals
- continuous improvement of the company's operations
- compliance with the consumer and other parties requirements
- compliance with legislation
- stable quality of products from development to implementation
- ensuring labor safety and health protection of employees
Integrating standards in the company:
consolidates interconnected processes
eliminates fragmentation, contradictions and duplication of individual standard requirements
coordinates and organizes actions in the company, coordinates the approach to its management
All business processes of the company are associated with the quality and safety of products, therefore, every employee complies with the requirements of IPQS
Quality control at each stage of the production process
covers raw materials, intermediate products and each series of finished products
In 2017, Prime Minister Dmitry Medvedev presented
the highest national quality award to the WERTEKS pharmaceutical company
