What are the responsibilities of pharmaceutical factory QA?

Responsibilities

Work content

1. System aspects

1. Responsible for obtaining various types of drug management and related laws, regulations and technologies requirements, and carry out filing management and notification management;

2. Responsible for supervising the self-inspection of the quality management system to ensure its effective operation;

3. Responsible for system document management and change control; participating Formulation of process procedures and standard operating procedures;

4. Responsible for supplier audits;

5. Responsible for the specific work of monitoring and reporting user quality complaints and adverse reactions to products;

6. Responsible for the training of the quality management system;

7. Responsible for the daily management of verification documents, batch records and other files;

8. Responsible for deviation processing, Corrective and preventive measures and annual product quality review and analysis;

II. On-site supervision

1. Detection of environmental colonies in the production clean area and finger colonies of packaging personnel

2. Moisture and sterility testing of post-sterilized rubber stoppers and post-sterilized vials

3. Cleanliness testing of post-sterilized rubber stoppers

4. Post-wash and post-sterilized vials Detection of visible foreign matter

5. Detection of visible foreign matter in water samples after rubber stopper washing

6. Determination of pH and conductivity of process water

7 .Supervision of the implementation of process disciplines during the production process (each position) and supervision of each process parameter

8. Supervision of random inspections of the loading volume of powder injections during the production process

9. Production process Supervision of the appearance, capping and labeling of medium-powder injections

10. Supervision of the quality of external packaging such as labeling, boxing and cartoning at packaging stations

11. Cleanliness Detection of wind speed and suspended particles in the area

12. Supervise the disinfection of raw materials entering the clean area

13. Review of production instructions, material release, clearance supervision after the production batch is completed, and Inspection of batch report binding after the production batch number is completed

14. Supervision of destruction of outer packaging materials

15. Supervision of disinfectant preparation

3. Verification

1. Responsible for formulating the overall enterprise verification plan, including the responsibilities of the verification management organization, verification objects, verification items and verification content, etc., and conducting drug production verification.

2. Establish a verification team based on the objects to be verified, propose verification projects, formulate verification plans, and organize implementation.

3. Coordinate and promote the analysis during the verification process, and complete the verification report after the verification is completed.

4. After a certain period of production, verify and manage again.

5. Responsible for verifying evaluations and suggestions.

6. Responsible for verifying the monthly summary, yearly summary, and archiving the data and analysis content in the verification process in the form of files.

7. Responsible for verification result confirmation and status identification.

8. Verification, calibration and verification of measuring instruments.

Extended information

In the functional structure, each functional department sets up its own QA position, located under the senior manager and independent of the project team. QA is directly responsible to the senior manager, but needs to report to the project manager on business matters and is a project member. The advantage of this organizational structure is that QA can easily integrate into the project team, find substantive problems easily, and solve problems quickly.

The disadvantage is that each functional department is relatively independent, there is a lack of exchange and sharing of experience between departments, and there may be repeated investments in research on processes, methods, and tools. Under this organizational structure, because senior managers focus on business development, QA's career development is easily overlooked, and it is difficult to receive due training and promotion.

Reference material Baidu Encyclopedia - QA