GMP

The purpose of development and implementation of the quality system at the enterprise is to ensure that all the requirements for the manufactured products are fulfilled.

To achieve this goal, the enterprise implemented the following elements of the quality system:

1. “The Company’s quality policy” has been developed and communicated to all the company's employees.

2. The obligations and responsibilities of all the company's employees have been clearly defined:

- the organization chart has been developed and approved;

- the enterprise’s standard "Organizational structure, responsibility and powers of the managing personnel" has been developed;

- a set of provisions on structural subdivisions has been developed;

- a set of job descriptions reflecting job responsibilities of each employee has been drawn up.

3. The documentation system functions in compliance with the requirements of the enterprise’s standards and standard operating procedures.

4. Production and quality control are organized in conformity with the established requirements. All control and manufacturing operations are documented and approved by competent staff.

5. 5. Traceability of the entire manufacturing process and quality control is ensured by documenting of all manufacturing operations and achieved results in flow charts, packaging protocols, analysis protocols, logs and other approved fillable forms.

6. The use of low-quality raw materials in production is prevented by means of the following:

- list of approved suppliers;

- routine quality control and release of raw materials, excipients and semi-finished goods into the production area; Finished Products analysis and full release to market;

- compiled specifications for raw materials, materials, semi-finished products, finished products, packaging materials;

- raw materials are released into the production area only if the required quality specifications are met;

- a permit for products’ release to the market is issued only for the products conforming to all the requirements of the quality standard (the manufacturer's pharmacopoeial monograph) that successfully passed voluntary certification and declaration.

7. Provision of secure conditions for production of high-quality products:

- production facilities are designed, constructed and equipped in accordance with GMP requirements;

- cleanup, operation, maintenance and repair of equipment, premises and MEP systems are arranged in compliance with the documented procedures;

- measurements’ quality assurance system is developed and implemented;

- continuous monitoring of production conditions and quality of the procedures’ execution is ensured;

- conducting of planned self-inspection and validation activities;

- operating procedure in the event of occurrence and investigation of inconsistencies, as well as the operating procedure with regard to defective products are established.

- определен порядок действий при возникновении и расследовании несоответствий, порядок действий с забракованной продукцией.

8. The company is staffed with production personnel with appropriate qualification. All employees undergo primary training and then they get repeated periodic trainings at the enterprise. The effectiveness of training is monitored by testing both, theoretical knowledge and practical skills.

9. High level of discipline at the enterprise is provided through the following:

- the requirements imposed in job descriptions;

- internal labor regulations;

- procedure for emergency situations;

- control checkups of performance discipline by management personnel;

- planning of work of the company’s structural subdivisions and control of plans’ execution;

- bonus and penalty system.

10. 10. Ongoing analysis of products’ quality.

11. Change control system.

12. 12. To prevent the possibility of negative impact on the environment and patients, the risk analysis procedure is used when decision-making and investigation of nonconformities.

Canonpharma production is approved by the Regulatory Authorities as compliant with the requirements of the rules of the Good Manufacturing Practice.