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This is a global initiative to harmonize pharmaceutical regulation.

The purpose of ICH is to develop uniform requirements for standardization, quality control, efficiency, safety, production and registration of pharmaceuticals. The quality system of the company takes into account the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH):

  • ICH Q8 Pharmaceutical Development
  • ICH Q9 Quality Risk Management
  • ICH Q10 Pharmaceutical Quality System +

    ICH Q10 contains a modern perception of approaches to ensuring the quality of medicine, establishes a new level of management for the pharmaceutical enterprise, and complements the requirements of GMP. The guidelines emerged as a result of the joint work of industrial companies and regulators in Europe, Japan and the United States.

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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.


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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.
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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.
WERTEKS holds national and international certificates of compliance with the requirements of the ISO 22000 standard since 2019.

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.


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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
WERTEKS holds national and international certificates of compliance with the requirements of the ISO 9001 standard since 2016.
ISO 9001 Certificates
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.
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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.

At WERTEKS, GMP rules take into account compliance with the requirements for the production and quality control of non-sterile products and include:
  • 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.
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Integrated Quality System

Since 2013, the company had been building an Integrated Pharmaceutical Quality System (IPQS) based on national and international standards and best practices. The system was completed in 2019, however we keep developing and improving it so it becomes more comprehensive, universal and meets the present day requirements
Микроскоп
Линия

Image The system covers the development, implementation, production, storage and wholesale of pharmaceutical drugs, cosmetics and biologically active additive.

Image The system takes into account key modern standards and practices,

pertaining to the quality and safety of products produced in pharmaceutical companies in Russia and Western countries:

GMP
GMP — Good Manufacturing Practice
ICO_9001
ISO 9001 — «Quality Management Systems — Requirements» standard.
ISO — International Organization for Standardization
ICO_22000
ISO 22000 — «Food safety management systems — Requirements for any organization in the food chain» standard.
ISO — International Organization for Standardization
GDP
GDP — Good Distribution Practice
GVP
GVP — Good Pharmacovigilance Practice
ICH
ICH guidelines — International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

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

Integrating standards in the company:

Пазл

consolidates interconnected processes

Квадраты

eliminates fragmentation, contradictions and duplication of individual standard requirements

Связь

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

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Winner of the Russian Government Quality Award, 2017
Read more

In 2017, Prime Minister Dmitry Medvedev presented

the highest national quality award to the WERTEKS pharmaceutical company


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