Responsibilities of Quality assurance Department in Pharmaceutical Industry


Quality Assurance department is independent of the other department but responsible for all activity and documentation performs in all departments which directly or indirectly related to the quality of the product.


Quality assurance involved in every stage and phase in the pharmaceutical industry. From the development of the drug to the distribution or dispatch of the material.

It also involves in the entire department starting from ware-house, manufacturing unit, quality control, engineering department, safety, and logistics.

Quality management system and the in-process quality assurance is the two basic area of the Quality assurance department.
Quality management system includes activities like Corrective action preventive action (CAPA), change control, Deviation, Out of specification and to comply with the regulatory requirements and evaluation.
- In process quality assurance ensures that production operations and in-process quality parameters are performed as per the requirements.

Following are the responsibilities of the Quality Assurance Department:
Quality Management System:
-Preparation, review and approval of the quality manual, Site master files, validation master plan, quality objective, and quality policy.

-To prepare review and approval of the Standard operating procedure of the quality assurance department.

-To review and approve of standard operating procedure of the other departments.

- Provide the training to concern person related to SOPs.

- To monitor activities and documents are properly perform as per the SOPs. Ensure that proper implementation of the SOPs in all departments.
-To complies the regulatory requirements as per the guideline.
-Preparation and review of the Annual product quality review.
-Register and control the change control, CAPA, deviation, OOS, OOT, etc in a proper way, and maintain the log.
-Handling of market complaints and rejection of any batches .maintain proper record of rejection and market complaint. Investigate them in proper way
-To review the change control properly and make the action plan accordingly, if required perform the risk analysis. Ensure that Proper implementation of changes and change control activity.
-To investigate the deviation and OOS in a proper manner and find out the root cause of the deviation. Proper CAPA shall be taken and implemented
-To prepare the stability schedule and stability plan.
- To prepare the validation protocol and report.

In-Process Quality Assurance:
-It include the monitoring of activities and documentation like Batch manufacturing record and batch packing record,
- Ensure that equipment usage record is properly filled
-To ensure that equipment used for the manufacturing of the product is properly cleaned. And the cleaning record of the equipment is properly filled.
- To ensure the all equipment and instrument used in manufacturing are calibrated
-Ensure that in-process sample will be sent on time and in-process quality control parameters are properly reported  
-If any deviation is observed register the deviation in proper manner and investigation of the deviation.
-Review the BMRs, quality protocols finished product.
Here we discussed the responsibilities of the quality assurance department(not limited to).


1 comment:

  1. This informative article offers valuable insights into pharmaceutical quality control and assurance, underscoring their pivotal role in ensuring the safety and effectiveness of pharmaceutical products. It covers a wide range of topics, from material control to manufacturing practices, and highlights the significance of meticulous record-keeping. The discussion of the organizational structure for quality control further emphasizes the unwavering commitment to maintaining high pharmaceutical quality standards.

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