SOP ON ROLES AND RESPONSIBILITIES OF QA DEPARTMENT

1.0 Objective: To outline the roles and responsibilities of the quality assurance department

2.0 Scope: This SOP shall be applicable to Personnel working in quality assurance and activities of QA department.

3.0 Responsibility: Head QA shall be responsible for implementing the procedure

4.0 Definition: Quality assurance is the sum of the activities that individually or collectively influence the quality of the Product, ensuring the products produced are of acceptable quality, safety and efficacy. below are some of the roles and responsibilities of QA department.

5.0 : Roles and Responsibilities

5.1: QA department is responsible for establishment of quality systems according to Regulatory guidelines

5.2 QA shall be responsible for Preparation, Review, approval, revision of standard operating procedures by coordination with user departments

5.3 QA shall be responsible for review and approval of master formula records, BMR issuance, logbooks issuance etc.

5.4 QA shall be responsible for creation of quality policy of the company

5.5 QA shall be responsible for ensuring all the manufacturing activities are in compliance with the current cGMP practices

5.6 QA shall handle the deviations, recalls, market complaints etc.

5.7 QA shall do the vendor qualification activities

5.8 QA department shall be responsible for training of the personnel on cGMP and the standard operating procedures

5.9 QA department shall be responsible for Qualification and validation activities of the process and equipment which include equipment qualification, Process validation and cleaning validation.

5.10 QA department is responsible for preparation of protocols for validation and qualification activities

5.11 QA shall be responsible sampling and in-process activities in the manufacturing area

5.12 QA department is responsible for performing the batch release activities.

5.13 QA department is responsible for performing the line clearance activities in the manufacturing area

5.14 QA is responsible for ensuring all the SOP are followed in the processing areas and responsible for ensuring the products produced are of acceptable quality.

These are some of the roles and responsibilities of quality Assurance department.