Quality Control (QC)
Production and operation unit
۱۰ مرداد، ۱۴۰۲
An overview of quality control (QC):
One of the components of quality management is the quality control (QC) system, whose philosophy is to ensure sufficient efficiency of products in all stages of product preparation for market release. Its main task is to complete quality and focus on implementing the latest quality control guidelines in accordance with international standards. The quality control (QC) system, in addition to maintaining quality in all stages of production in a completely tangible way, also improves and revises all matters related to this system as a continuous process. Quality control (QC) is one of the most important and main units of every organization and factory. Because if every factory does not have this system, it will stop competing with others and lose its customers over time.
The production of a medicinal product is a long and time-consuming process. This process tests the following:
1) Drug identification
2) Performing laboratory tests
3) Animal studies and other clinical trials
4) Finally, legal registration
After the approval of most of the regulatory organizations, including the Food and Drug Administration, to increase and increase the effectiveness and safety of the produced drug, it is tested in advance to identify and control the quality and degree of purity and its effect on the patient. . Then, after passing these steps and receiving the final approval, the drug products are sent to the market for use. For this reason, drug validation and quality control during production is very important, despite its problems. The main purpose of quality control (QC) is to inspect raw materials and perform some in-process controls so that the production of the final product meets quality approval.
Quality control (QC)
The development of any quality control (QC) system requires which items?
Implementation of quality control system requires resources, expertise and time. The general quality control methods related to all existing departments are carried out in a period of time. This system plays an important role in improving the output of the process. For the development of any quality control system, it is necessary to consider and check the following:
1) Time set for review
2) Dedicated resources for quality control for different categories and consolidation process
3) Review and check the results
4) access and access to information related to data and release agents
5) Data quality
6) Methods to ensure the confidentiality of inventory and resource information
7) Archival information requirements
8) Level of quality control appropriate for each source category
In practice, the quality control system (QC) is only a part of the development process, and existing organizations do not have unlimited resources. With the requirements of this system, quality and accuracy are improved and uncertainty is reduced. A well-functioning quality control (QC) system makes more effort to categorize key resources and areas where data and methodological changes occur than other resource categories.
Quality control (QC)
Examining the duties of the quality control unit (QC):
In summary, the duties of the quality control unit (QC) are:
• Quality and health control of raw materials and packaging products
• Quality and health control of packaging items
• Quality control and environmental conditions of production in terms of hygiene and cleanliness
• Preparation of documents
• Quality and health control of semi-finished products
• Calibrating and checking the accuracy of the devices and equipment
• Control and confirm the quality of final products
• Periodic quality control on the samples of products supplied to the market
• Validate the methods of analysis and cleaning of production lines
• Timely and correct performance of required product tests and inspections
• Training of production department employees in matters related to quality
• Conducting product tests and measurements in accordance with quality control plans
• Timely implementation of calibration of equipment and supplies and monitoring and testing in production
• If detected, stop the production line
• Maintenance of laboratory equipment and control tools affecting product quality
• Care and protection of control tools affecting product quality
• Search for non-conformities in products
• Implementation and performance of all responsibilities assigned by the relevant manager.
• Implementation of statistical control process (SPC)
• Research to access the latest inspection standards and sampling plans for their use in the company
Periodically conducting audits of production processes and providing suitable and acceptable methods for production to reduce or eliminate deviations.
• Measuring the characteristics and capabilities of the production process and providing appropriate solutions and methods to increase the capabilities of the machines and equipment in the company.
• Cooperate in performing all the duties and responsibilities for the implementation of the quality control system.
