Procedure for Quality Assurance system

1.0	PURPOSE To lay down the procedure for Quality Assurance Department for co-coordinating the development and maintaining quality policy and system.
2.0	SCOPE This SOP is applicable for effective implement of GMP thereby ensuring excellence in product process and system
3.0	RESPONSIBILITY QA Executive/Officer/IPQA Chemist
4.0	ACCOUNTABILITY  Head Quality Assurance
5.0 5.1	PROCEDURE DEFINITION:Quality Assurance is a support function to production, store and quality control department. It provides an independent check and support to manufacturing and the all activities and parameter are as per preset standard.  The quality assurance department extends its service other function like vender/ supplier evolution etc.
5.2 5.3 5.3.1 5.3.2          5.3.3 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.4.9 5.4.10 5.4.11 5.4.12 5.4.13 5.4.14 5.4.15 5.4.16 5.6.17 5.7 5.7.1 5.7.2 5.7.3 5.7.4 5.7.5 5.7.6 5.7.7 5.7.8 5.7.9 5.7.10	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.   FUNCTION OF Q.A. OBSERVER:  He shall be on shop floor and whether the activities are carried out as per SOP.  He will give Q.A. observation round report to concerned officer, who will take corrective action in     consultation with the department head.  The compliance report is submitted to manager QA. GUIDELINES FOR Q.A. OBSERVER: 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 available for deviation. Timely entries of operation. Person trained for the job. Suitability of area and equipment. Calibration of equipment / instrument regulatory done.  In process control as per procedure.  Quality Control specification and SOP reviewed and approved.  Process is validated.  Retrieval, issue and storage of material in store as per SOP.  Material stock verification done regularly.  Dispensing done as per sop. Approved label fixed with each and every raw material and packing material. Safety norms being followed.  FUNCTION OF Q.A. REVIEWER:  He shall review all batch documents independently to ensure. All entries are made correctly in batch records. The entries are as per desire time interval and frequency. The entries are properly initiated.  Review yield of each process and compared with standard.  Review timing of each process and compared with standard.  Highlight abnormal wastage/ process timing of unit process.  The batch document will be supported with an incidence notification sheet carrying remarks as per SOP. Tally of overprinting instruction with product specification.  Initial checks and records. Rejects analysis data. (Manufacturing and packing activity it should be within in standard limits as per  Specified in  BPR).  Certified specimen of printed packing material as per SOP.
6.0	REFERENCES     NIL

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
NIL

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
GMP						Good Manufacturing practice
BPR						Batch Processing Record
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)