SOP on Responsibilities of Quality Operations Departments


SOP on Responsibilities of Quality Operations Departments
1.0 Purpose: This SOP describes the basic responsibilities of Quality Operations at the Company.
2.0 Scope: This SOP applies to all Quality Control and Quality Assurance staff of the company.
3.0 Responsibility: Quality Assurance manager is responsible to ensure that procedure is followed..
4.0 Materials and Equipment: None
5.0 Procedure:
5.1 Quality Control Responsibilities
5.1.1The Quality Control laboratory has the responsibility and authority to approve or reject the raw materials, packaging materials and drug products.
5.1.2 The responsibilities and procedures applicable to the Quality Control laboratory are provided in writing and such written procedures should be followed.

5.2 Quality Assurance Responsibilities
5.2.1 The Quality Assurance Manager has the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, purity and stability of   the product.
5.2.2 The Quality Assurance Manager has the responsibility and authority to approve or reject any changes in previously approved plant, equipment processes, procedures, and packing components before utilization in the manufacture, processing, packing, and holding of a drug product.
5.2.3 The responsibilities and procedures applicable to the Quality Assurance Manager are available in writing and such written procedures should be followed.

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