Quality Assurance Department
Department of Quality Assurance:
Basic need of any business is to satisfy the customers, which is rationally possible only through quality services and products; therefore quality should be built in the product. Central role of Quality Assurance (QA) is to assure the quality through well planned activities and not just by testing the quality of final product.
Quality Assurance act as caretaker of the Pharmaceutical Quality System (PQS) which are necessary to build quality in to the services and products which means QA is essential for better business plans and progression.
Responsibilities of the Pharmaceutical Quality Unit are: Top 10 responsibilities:
- To establish the quality system (QMS) to ensure compliance to GXPs and keep in current with good industry practices, as applicable to the mission.
- To audit compliance to the quality system and report on the performance of the QMS.
iii. To establish procedures (SOPs,), documents (formats), specifications for in-house and contract organizations and for vendor validation.
- To review and approve or reject all things relevant to cGMP requirements such as procedures, protocols, test methods, and specifications—including changes to these documents, production batch records and make the final decision to release a product lot into commerce.
- To ensure investigation of nonconformance and enforcement of emerging quality assurance tools (CAPA, PAT, cGMP, QRM, etc.) to avoid any out of specification (OOS) incidents. To report relevant investigations to FDA if it is serious and unexpected and to keep management informed.
- Liaison with Research & Development, New Product Introduction and process.
vii. To establish manufacturing controls and to perform laboratory tests or examinations.
viii. To describe responsibilities in writing to establish complete and compliant procedure
- To remain independent to avoid conflict of interest between regulatory responsibilities and actual daily activities. It is Independent reviewer and approver for all others departments.
- Regulatory Compliance Duties: QA holds primary responsibility for regulatory, validation, compliance and must educate the QA employees and other key personnel about relevant national, international and regional regulations and alert them for changes in these documents in organizations internal depts.
Department of Quality Assurance is established in 2008 since then the department is doing good in the academic and research activities. The department has sanctioned intake of 10 seats and having sufficient doctorate faculty to guide the students in their research.