Quality Control & Quality Assurance Department
In the pharmaceutical industry, quality is the most critical issue that must be given priority over all other matters. This is why many regulations, policies, and controls are of great importance and must be followed.
Therefore, in order to achieve such a goal, a quality management system covering all organizational units and relevant personnel is essential. At Raha Pharmaceutical Company, various functions related to quality management and the relationship between them are considered important. Quality Management, QA, GMP, and QC have a hierarchical relationship, in which Quality Management is at the top, with all organizational policies concerning quality implementation. Following this is the Quality Assurance (QA) Department, which ensures that the company achieves the relevant policies and that GMP regulations and standards are properly followed. We consider GMP as part of QA, ensuring that products are consistently manufactured and inspected and controlled in accordance with quality standards appropriate to their intended use and approved by the competent authority.
Quality Assurance is a broad concept and approach. QA encompasses all activities that, individually or collectively, can affect the quality of a product.
Quality Assurance consists of all organized arrangements within the company. These arrangements are intended to ensure the quality of products and their suitability for their intended use.
The necessary arrangements and mechanisms for manufacturing products, supplying raw materials, and using appropriate raw materials and packaging materials are carried out by the Quality Assurance Department.
At Raha Pharmaceutical Company, the Quality Assurance Department, with the role of supervising the performance of operational units that affect product quality, includes the Training, Product Release, Documentation and Validation, Calibration, Customer Complaints Handling, Internal Audits, Occupational Health, ISO, and Suggestion System units.
Training Unit: Responsible for providing training for all personnel, including Basic Training for newly hired personnel, as well as Continuing Training for other personnel, with its effectiveness periodically evaluated.
Product release, training, documentation, calibration, and validation are among the main responsibilities of this unit.
Product release includes reviewing the entire manufacturing process of a product, reviewing all Quality Control Laboratory documentation related to the relevant product, and finally confirming the validity of the documents related to the manufacture of a product. In the release process, after ensuring the validity of the production documents, the green product approval form for release from the company is provided to the Technical Manager, and after approval by the Technical Manager, the relevant green form is sent to the quarantine warehouse and attached to the manufactured product.
Considering the importance of documentation according to Good Manufacturing Practices (GMP), the documents of Raha Pharmaceutical Company are prepared, reviewed, and finally coded and maintained by the Quality Assurance Department.
The Quality Assurance Department acts as the supervisor of the company’s Technical Department and the proper operation of equipment, and also plans the periodic control of the company’s equipment alongside its supervision. The Quality Assurance Department is also responsible for the calibration and/or verification of production equipment.
Another responsibility of the Quality Assurance Department is to conduct internal audits of the company’s units to confirm the proper implementation of Good Manufacturing Practices and ultimately maintain product quality, which is carried out periodically at Raha Pharmaceutical Company. The responsibility for the qualification and validation of the company’s equipment also lies with this unit.