SOP for Testing of samples to external laboratory

This Document describes (Standard Operating procedure) SOP for Testing of samples to external laboratory.

SOP for Testing of samples to external laboratory.

I. Purpose & Scope:

  • The purpose of this SOP is Testing of samples to external laboratory.
  • This Standard operating procedure shall be applicable for Testing of samples to external laboratory.

II. Responsibilities:

  • All Quality control personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

Procedure for Testing of samples to external laboratory :

  • Sample of Raw material / Finished products is received for analysis by IPQA.
  • QC Officer/Executive shall check the tests to be perform at public testing laboratory by referring specification and Test procedure.
  • QC officer/Executive shall prepare the Outside testing laboratory requisition form for particular test to be performed at public testing laboratory. Refer Annexure I.
  • The entries of the sample sent shall be made in the register by the QC Officer/Executive. Refer Annexure II.
  • Pack the sample in double Polybag or bottles with proper labeling.
  • Sample bags/bottles shall be packed in small box with proper protection to avoid any damage during transport. Address shall be pasted on box.
  • Handover the box containing sample to admin department to courier the same with nonhazardous declaration form.
  • The photocopy of outside testing laboratory requisition form shall be taken and kept at designated file. The testing of particular product shall be communicated to public testing laboratory through telephone or mail.
  • Analysis status shall be tracked through telephonically.
  • After getting the results from public testing laboratory, record the results in the respective technical data sheet.
  • If the analysis asked for in- house specification, ensure that the test procedure is sent to the Public testing Laboratory before dispatch of the sample or send with the sample.
  • After receiving the analytical results for testing of samples to external laboratory., QC officer/ Executive shall review the analytical data with test detail & results for complies as per respective specification and sign the COA for results & limits for verification.
  • The Assessment shall be done of results and If any discrepancy observed during the review, same shall be intimate to department head and head QA.
  • Department head shall communicate the same to outside lab and get the investigation with corrective action and preventive action from outside lab.
  • The analytical data from esting of samples to external laboratory, shall be transcript to test data sheet and shall be verified by reviewer against respective specification.
  • The analytical report with certificate of analysis from outside testing lab shall be kept with respective analytical report.

IV: Frequency:

As and when required

V: ANNEXURE:

Annexure I: Outside testing laboratory requisition.

Annexure II: Sample sends to public testing laboratories inward register.

 

ANNEXURE –I

OUTSIDE TESTING LABORATORY REQUISITION

 

                                                                                             Date:__________________

Name of Sample  
Batch No. A.R. No.  
Mfg. Date Exp. Date  
Date of sampled received Mfg. Lic. No.  
Name of Manufacturer Quantity Mfg/received  
Name of Supplier Quantity sent

(In Duplicate)

 

 

Test to be performed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Analysis to be carried out as per MOA-IP/BP/EP/USP/IN-HOUSE

 

Sent By Approved By
Name    
Signature    
Date    

 

 

  ANNEXURE –II

  SAMPLE SENDS TO PUBLIC TESTING LABORATORIES INWARD REGISTER                    

Sr.

No.

Sample Send Date

 

Material/Product

Name

A.R. No./

Batch No.

Name of Tests Sample send by Remark
             
             
             
             
             
             
             
             
             
             
             

 

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