Quality management of the product
At the enterprise quality control and quality assurance system is created, policy of quality assurance is defined:
- organization of work on quality in accordance with international and national requirements of the GMP and ISO standards, acting normative documents and legal acts of the Republic of Belarus;
- safety and efficacy safety assurance of the manufactured products;
- full meeting of consumer’s demands;
- export market development;
- ensuring the reliability of manufacturing processes ensuring consistent quality of products;
- support of production with highly professional staff;
- ensuring of energy saving and efficient use of fuel and energy resources;
- improving the economic situation of the company and employees.
Manufacture of all the pharmaceutical forms released by the enterprise, is certified for compliance with the requirements of TAP 030-2013 (02040) "Good manufacturing practice".
The company is preparing for the certification for compliance of manufacture of medicines in tablets, packets "Sachet" and banks with GMP standards.
To ensure compliance of manufacturing and product with the requirements and standards of GMP, the company annually planned and implemented activities aimed on monitoring the functioning of quality assurance and management, implementation of the quality policy:
- holding self-inspections (audits) to implement the rules of GMP;
- carrying out personnel training;
- Validation and certification processes of technological equipment;
- change control;
- development, updating documentation on production and quality control of processes and products;
- checking the contents and storage of dossier on a series of medicines;
- registration of medicinal products and substances;
- management of external regulatory documentation in the enterprise;
- control the efficiency, safety and quality of medicines;
- study of stability drugs;
- assessment and approval of suppliers of raw materials;
- scheduled preventative maintenance of production facilities, installed equipment and measuring instruments
- Organization of checking, certification of measuring devices and test equipment
Control of functioning of quality assurance system and quality management is provided by quality assurance department.
Deputy Quality Director is responsible for general management of quality assurance and management; as an authorized person He allows a release of the series of medicines in the implementation. On distributor warehouse (storage of finished products) only the medicines, approved to pass to the warehouse for sale, are brought.
Deputy Director for Production, Technology, Warehouse Manager, Technical Section operate in quality sphere in the structural units.
Quality Control Department carries out quality control and evaluation of raw and packaging materials, intermediate products, finished products, and monitors the production environment. From each batch of finished pharmaceutical products samples, that are stored for repeat testing of products, are selected.
Procedures and specifications that define test methods and parameters of controlling processes, raw materials, intermediates and finished products in accordance with current regulatory guidelines are developed.
Procedures that define way of a document control, method of personnel training, and supplier characterization and also developed at the enterprise.
Audits are carried out in order to verify production, control, storage of raw materials and products for compliance with the requirements of GMP. The program contemplates examination of all elements of the quality system at least 1 time per year.
The need for training of personnel is determined by taking into account the established periodicity of training, in accordance with planned changes in the technological process, plans to develop new products, with the necessity to develop new skills or new operations, in keeping with changes in the documentation, results of internal and external audits.
The concept of enterprise in the field of validation (qualification, certification) is defined. Equipment qualification is held by the company itself and by third parties.
The purpose of validation is a regular monitoring of the prescribed parameters, verification of production equipment and processes in order to provide evidence of conformity the requirements for clean rooms, equipment, process reliability and compliance with manufactured medicines.
The following is been validated (certified):
equipment, systems of water - and air handling , process of equipment cleaning, the basic technological processes of manufacturing and packing of medicines.
When making significant changes in the processes, including changes in equipment or raw materials and packaging materials, which may affect the quality of the products are carried out unscheduled validation.
Responsibility for monitoring and coordination of works on reclamations is born by deputy director of Quality (Authorised Person).
At the enterprise control over the efficiency, safety and quality of drugs is exercised. In accordance with established procedures and legal requirements are carried out:
- pre-clinical and clinical tests during development of new products;
- validation of critical processes and cleaning procedures;
- quality control and evaluation of the dossier for series;
- study of current stability;
- collecting and analyzing data of customer complaints and reclamation;
- collection and analysis of information about identified adverse drug reaction.