SOP for Quality Assurance Department

PURPOSE

To lay down the procedure for the Quality Assurance Department for co-coordinating the development and maintaining quality policy and system.

SCOPE

This SOP is applicable for the effective implementation of GMP thereby ensuring excellence in product process and system

RESPONSIBILITY

QA Executive/Officer/IPQA Chemist

ACCOUNTABILITY

Head Quality Assurance

PROCEDURE

Definition

• Quality Assurance is a support function for the production, store, and quality control departments. It provides an independent check and support to manufacturing and all activities and parameters are as per preset standards. The quality assurance department extends its service to other functions like vendor/ supplier evolution etc.
• The group performs two basic functions i.e. Q.A. observation and document review. The person making the Observation will be nominated as IPQA chemist and who reviews the document as Q.A. reviewer.

The function of the QA Observer

• He/She shall be on the shop floor and whether the activities are carried out as per SOP.
• He/She will give a Q.A. observation round report to the concerned officer, who will take corrective action in consultation with the department head.
• The compliance report is submitted to the manager QA.

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Guideline of QA Observer

The following list shall be used as a guideline for observations

• Any need to modify the sop to sharpen the controls.
• Cleanliness of area.
• Basic norms of GMP beginning followed.
• Authorization is available for deviation.
• Timely entries of operation.
• A person trained for the job.
• Suitability of area and equipment.
• Calibration of equipment/instrument regulations done.
• In-process control as per the procedure.
• Quality Control specification and SOP reviewed and approved.
• The process is validated.
• Retrieval, issue, and storage of material in-store as per SOP.
• Material stock verification is done regularly.
• Dispensing is done as per SOP.
• Approved label fixed with each and every raw material and packing material.
• Safety norms are being followed.

The function of the QA Reviewer

• He/She shall review all batch documents independently to ensure.
• All entries are made correctly in batch records. The entries are as per desired time interval and frequency.
• The entries are properly initiated.
• Review the yield of each process and compare it with the standard.
• Review the timing of each process and compare it with the standard.
• Highlight abnormal wastage/process timing of the unit process.
• The batch document will be supported with an incidence notification sheet carrying remarks as per SOP.
• Tally of overprinting instructions with the product specification.
• Initial checks and records.
• Rejects analysis data. (Manufacturing and packing activity should be within standard limits as Specified in BPR).
• Certified specimen of printed packing material as per SOP.

ANNEXURES

Nil

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

GMP: Good Manufacturing Practice

BPR: Batch Processing Record

REVISION HISTORY

Nil

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