STANDARD OPERATING PROCEDURE AUDITS OF CONTRACT LABORATORIES

STANDARD OPERATING PROCEDURE

SUBJECT:                      AUDITS OF CONTRACT LABORATORIES

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines to assess the testing facilities in the Contract Laboratories.

2.0       POLICY:

To lay down a procedure for audit of contract laboratories    

3.0       PROCEDURE:

3.1       Permission shall be obtained from the contract laboratories to audit their premises.

3.2       The auditing shall be done on the following:

3.2.1    House keeping

3.2.2    Qualification of the Analyst

3.2.3    Specification and method of testing    

3.2.4    Calibration of the equipment

3.2.5    Frequency schedule for calibration     

3.2.6    Working standards      

3.2.7    Records

3.2.8    Standardization of volumetric solutions

3.2.9    SOP’s   

 3.2.10             Pest control 

3.2.11 BMR’s & BPR

3.2.12 All Microbiological related documents.

3.3       A report shall be prepared with observations corrective action, selection criteria and approval process for use. Format is included in Annexure-1 Sop No.

3.4       The samples will be sent to the contract labs, along with approved test methods.

4.0       FREQUENCY: Once in a year.

5.0       RESPONSIBILITY:

6.0         REVIEW GUIDE: Audit Report.

7.0       ANNEXURE: 1. Audit format for contract laboratory

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x