Functions Of Quality Assurance Department
This documents describes in brief about the Functions Of Quality Assurance Department in Pharmaceutical Industry.
Functions Of Quality Assurance Department
Objective :
- This document describes the functions / principle duties and the responsibilities of Quality Assurance Department.
Responsibility :
- Quality Head and The personnel of the Quality Assurance department shall be responsible for carrying out the Functions and performing the duties assigned to them.
Scope :
- This Procedure is applicable to all personnel’s who are working with various functions performed by the Quality Assurance department.
Procedure :
Functions of the Quality Assurance Department are as listed below: which shall be followed by all the personnel of the Quality Assurance Department.
- To review, control, issuance and retrieval of standard operating procedures.
- To control Master manufacturing Documents and Technical Analytical Documents.
- Issuance of Batch Manufacturing and Packing Records, Raw Material Specifications, Packing Material Specifications, Technical Analytical Documents and In process specifications of the Quality Control.
- To monitor the various Manufacturing activities. To conduct the In Process activities.
- To review the Batch Manufacturing Records and Release Finished Goods.
- To perform cleaning validation and process validation.
- To approve Equipment qualification protocols and Reports.
- To provide approved vendor list and to ensure incoming materials are from Approved vendors.
- Handling of Change Controls / Deviations and Incident Report.
- Handling of Customer Complaints.
- To conduct Self – Inspections and ensuring their corrective and preventive actions are taken.
- Coordinating with the regulatory Department for their requirements.
- Training of staff member (GMP & GDP related).
- Out of Specification / Out of Trend results and their Investigations.
- Effective Handling of the Returned Goods.
- Prepare and review the Annual Product quality Review.
- Collection of control samples, preservation and their maintenance.
- Maintenance of all the Records / Documents pertaining to Quality.
- To prepare and update Site Master File.
- To prepare and update Validation Master Plan.
- To adhere to Master Validation Plan for Validation Activities.
- To Review Analytical Method Validation.
- To perform Hold Time Study and Temperature Mapping protocol.
- To perform Quality Risk Assessment
- Releasing of batches to market
