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.