MainProductionQuality management

Quality management

The main goal of GEROPHARM Group is to be a reliable manufacturer of good-quality, effective and safe drug products that help people to keep healthy and lead a high-quality life.

All GEROPHARM’s manufacturing sites have a license for conducting activities on the production of pharmaceutical products - pharmaceutical substances and drug products.

All GEROPHARM’s manufacturing sites meet the requirements of the Rules on the organization of drug production and quality control approved by the Order of the Ministry of Industry and Trade of the Russian Federation dated June 14, 2013 No. 916.

In March 2014, GEROPHARM successfully confirmed its compliance with the Good Manufacturing Practice requirements from the State Administration of Ukraine on Medicinal Products and received the GMP certificate 025/2014/SAUMP/GMP dated April 7, 2014.

The created pharmaceutical quality system that functions in the company is supported by the prescribed documents. The system embraces all aspects of GMP and ISO 9001. The efficiency of the pharmaceutical quality system and proper control are provided by the quality assurance (QA) and quality control (QC) units.

The basic pharmaceutical quality system principles and the regulations, ensuring the compliance with GMP and ISO 9001, are defined in Site Master File (SMF), Quality Manual and Quality Policy.

The company conducts the logging of all procedures, controlling and other processes, and also the ways the quality system techniques, including the processes of production and packaging, are carried out. There are special procedures for the assessment of production protocols, packaging protocols for the series of finished products, quality tests results at all critical points of drug production, and also for making profiles for all product series. The production control procedures allow to eliminate the risks of cross-contamination. Before finished products can enter the market, they must go through the assessment process, which is supposed to prove their compliance with the established requirements, set by the product manufacturing regulations and the registration dossier with the following obtaining of the corresponding permission. The permission to put drug products into civil circulation can be provided by an authorized person.

When the drug products are put into circulation, there are 3 authorized people in GEROPHARM Group who can prove that the products satisfy the requirements, established during their state registration. They also guarantee that the products are manufactured in accordance with the rules of drug production and quality control.

The whole staff in the company is responsible for the quality of the product. The efficiency of the pharmaceutical quality system is examined by a number of self-inspections. The appropriate efficiency level is provided by implementing some preventive and corrective actions.

As the obligatory part, the company’s pharmaceutical quality system also includes the system of assessment and qualification of starting raw and packing material suppliers/manufacturers, the system of change management, the system of derivation control, the system of quality review and the system of risk management and etc.

There is also the system of staff training that embraces all people who are engaged in the production of drugs, their storage, product quality control and who are responsible for the proper functioning of technical systems on manufacturing sites and etc. There are documented procedures in respect of training programs, trainings and learning efficiency evaluation.

In order to confirm the consistency of existing processes and prove the compliance with the current standards for both initial raw materials and finished products and in order to identify the trends and opportunities for the product improvement and the process itself, each year GEROPHARM makes the reports on product quality.

In order to prove the compliance of critical processes with the specified requirements in accordance with the validation master plan, a number of validation activities are conducted. Due to the fact that the company has its own validation testing equipment stock, the company by its own efforts can perform the attestation of clean rooms, qualify the engineering systems, conduct the qualification of equipment (thermostats, autoclaves, dry-air sterilizers, climatic chambers, refrigeration plants) and carry out the mapping of storage areas and etc.

The pharmaceutical quality system gives an opportunity to provide, support and control the compliance with the target indicators at all stages of the product lifecycle.

Quality Policy:

  • Development, production and drug quality control (Quality, Safety, Efficiency)
  • Quality achievement by following the regulations of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Medical Practice (GMP), Good Distribution Practice (GDP)
  • Precise distribution of roles and responsibilities. Full staff involvement in the creation of the quality system
  • A sufficient number of trained personnel at all levels
  • Compliance with the national and international legislation and its own System
  • Willingness to consider all remarks made by competent authorities in the course of inspections
  • Introduction of advanced technologies and new control methods