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Quality

The pharmaceutical production is one of the most responsible fields of manufacturing, as it relates to human life and health, therefore the pharmaceutical industry is faced to particularly high quality requirements.

In 2003, Grindeks became the first local drug manufacturer to receive the Good Manufacturing Practice (GMP) certificate, thus, the company is certified and operates under the Good Manufacturing Practice standard, which also serves as a guarantee that Grindeks is working according to the European Union’s and the world’s requirements.

Significant resources have been invested not only into the manufacturing and control equipment modernization, but also in educating the personnel, which is of particular importance, as in the implementation of GMP it is vital to ensure that every employee is competent and able to ensure the quality of products and processes.

To confirm that Grindeks’ products are manufactured and controlled in accordance with GMP requirements and those manufacturing and control methods approved on the submitted registration documentation, Grindeks is regularly inspected by the Latvian State Agency of Medicines, thus, the company’s conformity to the GMP standards is approved by the GMP certificates, issued by the Latvian State Agency of Medicines, and verifiable on EudraGMDP database.

In addition, Grindeks is regularly inspected by GMP authorities from different countries:

  • since 2001, four inspections on the manufacturing of active pharmaceutical ingredients, quality assurance and quality control by the U.S. Food and Drug Administration (FDA) have been successfully held
  • in 2014, after inspection by Japanese government institution – Pharmaceuticals and medical devices agency (PMDA) –  allowance to continue Grindeks’ cooperation with Japanese companies in active pharmaceutical ingredient business was received
  • every three years, GMP audits on active pharmaceutical ingredient and/or final dosage form manufacturing, quality assurance and quality control are held by Grindeks’ cooperation partners and clients

To guarantee the highest quality and safety for Grindeks’ products, as well as their availability to patients, it is of great importance to verify our cooperation partners also continuously improve their quality assurance systems and perform their actions in accordance with GMP and/or GDP requirements, therefore our specialists annually perform audits for number of active pharmaceutical ingredient manufacturers, wholesalers and contractual partners.