SOP For roles and responsibilities of quality assurance department is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure has been established to provide guidelines to be followed by Quality Assurance Department.

SCOPE

This SOP is applicable on the Quality Assurance Staff to discharge their assigned responsibilities.

RESPONSIBILTY 

Q.A Officer

ACCOUNTABILITY

Manager Quality Assurance   

ROLES OF QUALITY ASSURANCE DEPARTMENT

Inspection and sampling of raw material.

Inspection of packaging material.

Inspection of in-process manufacturing operations.

Plan and implement Quality Assurance monitoring and inspection activities against the specified parameter in ware house manufacturing and packing area.

Develop Standard Operating Procedure required for the department within the defined scope and insure their implementation.

Arrange and forward specifications, testing methods and reference standards to Drugs Testing Laboratory.

Execution and implementation of regulatory requirement against certain standards. 

Checking Manufacturing order and packing order as per defined standard. 

Develop and review design of packing components, specification and testing/inspection methods.  

Release of Finished Products.

Vendor performance evaluation.

Product recall when need arise

To review Master Formulation of Products 

Monitoring of calibration and validation activities 

Review and retention of Batch Manufacturing Record.

Product complaint investigation

Review of Returned Drug Product 

Finished Product Specification.

Conduct of Internal audit.