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


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