Quality Management

  A pharmaceutical quality system has been developed, documented, implemented and maintained in RUE "Belmedpreparaty" for the purpose of management and quality assurance.

  The procedures necessary for the functioning of the system are defined, and the officials responsible for their application are appointed in the quality system of the enterprise.

  In 2001 Quality Assurance Department (QAD) was established.

  21.05.03 the Policy of the top management of RUE "Belmedpreparaty" in the field of quality was developed, documented and adopted. Every year, the management of RUE Belmedpreparaty assesses the implementation of the Policy and, if necessary, updates it.

  The quality policy establishes quality objectives in accordance with the objectives of the enterprise, the ways of achieving them and enables all the workers, consumers and suppliers to get a clear idea of the attitude of the company's management to quality, its commitment to maintaining and continual improving the quality system.

  In the field of quality management and quality assurance the enterprise conducts the following activities:

  • Elaborates and maintains in actual state the Fundamental documents of quality system (Quality manual, Production areas' dossiers, Standards of the organization, SOPs and other). Implements management of quality system's documentation

  • Conducts staff training in the field of quality

  • Conducts internal audits (self-inspections) on implementation of GMP requirements, the activities with deviations are carried out

  • Fulfills activities with suppliers of raw materials and packaging materials: their approvals, monitoring, audits.

  • Carries out validation and qualification of facilities, engineering systems, equipment, processes, tests procedures.

  • Carries out control and work with changes that may affect the quality, efficacy and safety of the product or the reproducibility of the process.

  • Carries out inspection, analysis, evaluation and archiving of medicinal product batch records.

  • Carries out risk analysis and management for quality.

  • Permanently maintains a connection with consumers, examines all the claims concerning medicinal product quality, including verbal claims

  • Carries out the consideration of the nonconforming products and recalls, withdrawals.

  • Carries out planning and implementation of corrective and preventive actions.

  • Conducts product quality review.

  • Carries out the preparation of data on the functioning of the quality system for management review.

   The main goal of the enterprise is to guarantee the expected level and stability of product quality to ensure the safety and effectiveness of medicinal product.

   The enterprise received a number of GMP Conformity Certificates issued by both the authorized body of the Republic of Belarus and foreign authorized bodies.

Certification of manufactures for the compliance with the requirements of
Good Manufacturing Practice:

Manufacture of liquid sterile medicinal products in vials and ampoules (department №5).

Conformity Certificate No BY/112 05.03. 003 00003, expiry date 26.01.2018 г.

GMP

Manufacture of medicinal products in tablets and capsules (department №6).

Conformity certificate of medicinal product production to Good Manufacturing Practice (GMP) requirements No 015/2015/GMP, expiry date 23.12.2018 г.

Manufacture of medicinal products in powder (department №16).

Conformity certificate of medicinal product production to Good Manufacturing Practice (GMP) requirements No 016/2015/GMP, expiry date 23.12.2018 г.

Manufacture of antitumor medicinal products (сytostatics) in a form of lyophilized powders for preparation of solutions for infusions and injections, in a form of solutions for injections, in a form of concentrates for preparation of solutions for infusions in vials (workshop No.2)

Conformity Certificate No BY/112 05.03.003 00045, expiry date 30.04.2018 г.

GMP

Manufacture of medicinal products in tablets and capsules (department №17).

Conformity certificate of medicinal product production to Good Manufacturing Practice (GMP) requirements No 010/2015/GMP, expiry date 18.12.2018 г.

Manufacture of medicinal products in tablets and capsules (department №6).

Conformity certificate No 018/2016/SAUMP/GMP, expiry date 25.02.2019.

Romania:

Manufacture of antitumor medicinal products (сytostatics) in a form of lyophilized powders for preparation of solutions for infusions and injections, in a form of solutions for injections, in a form of concentrates for preparation of solutions for infusions in vials (workshop No.2);

Manufacture of antitumor medicinal products (cytostatics) in a form of lyophilized powders for preparation of solutions for infusions and injections, in a form of solutions for injections, in a form of concentrates for preparation of solutions for infusions in vials (workshop No.2).

Certificate No № 018/2015/RO, expiry date 30.01.2018.

Manufacture of aseptically prepackaged antibiotics in vials ( department 18)

Conformity certificate of medicinal product production to Good Manufacturing Practice (GMP) requirements № 029/2016/GMP, expiry date 12.08.2019.

Medicinal products in pre-filled syringes manufacture (workshop №5)

Conformyti Certificate № 038/2017/GMP, expiry date 03.02.2020.

Ointments, gels manufacture (experimental manufacturing workshop)

Conformity Certificate 3 039/2017/GMP, expiry date 03.02.2020.

Final dosage form manufacture (lyophilized powders for preparation of solutions for injections)(workshop №12)

Conformity Certificate № 040/2017/GMP, expiry date 03.02.2020.

Manufacture of liquid medicinal products (department №16).

Conformity Certificate No 043/2017/GMP, expiry date 16.03.2020 г.

Manufacture of medicinal products in tablets and capsules (department №6).

Conformity certificate of medicinal product production to Good Manufacturing Practice (GMP) requirements No GMP-00074/16/BY, expiry date 19.10.2019 г (Russian Federation).