Quality Assurance Department
Since 2014, the Company developed and operates Quality Assurance System, which according to national standard O’zDSt 2766:2013 (GMP) implements strict control over:
Compliance with conditions for aseptic production of medications, including independent quality control and risk management;
Mechanism for admission and recall of pharmaceutical products to the market.
Quality Assurance Department (QAD) implements the main tasks for managing the quality assurance system.
Applying the quality management system adopted in the Company, we created documentation regulating all aspects of the Company's activities, distribution of powers and responsibilities, in accordance with GMP.
The Company’s Supreme Management developed «Quality Assurance Policy». Description of QMS scope and the interaction of processes are presented in «Quality manual». In addition, using the implemented standards we developed and formalized processes, main procedures for QMS (PQM), standard operational procedures (SOP), position descriptions (PD), Validation management plan (VMP), User Requirements Specification (URS), Process instructions and other documents.
Production and quality control are carried out according to relevant internal and external regulatory documents, which eliminate the risk of mistakes in the work. Each action that affects the quality of products is confirmed by corresponding records.
We implemented a great work to qualify and validate technological processes and analytical methods. At present, there is a validation team that systematically conducts all qualification and validation work in the Company according to the approved schedule.
Company’s validation / revalidation policy is formalized in «Validation management plan» (VMP).
One of the main Company’s purposes is to guarantee that the manufactured goods not only comply with finished products NTD, but also that it is constantly manufactured under the same controlled conditions according to established procedure same for validation. In validation / revalidation process, the Company seeks to improve the quality assurance level and to identify and indicate the need to improve the production conditions.
Due to the validation procedure, control is provided both for technological, auxiliary equipment and production processes, and for the procedure of control tests made by the QAD laboratory.
The Company implemented the procedure for self-inspection and internal audit that helps to assess operational efficiency of quality assurance system not only according to ISO 9001:2008, but in compliance with all GMP requirements.In May 2016, «ATM SANITA PHARMA» JV LLC has been successfully audited for the compliance with National standard O’zDSt 2766:2013 (GMP). According to the audit resuls the Company’s quality assurance system can guarantee the stable release of high-quality, safe and effective medicinal products.