SOP For Sending Sample For Analysis To External Laboratory

  1. OBJECTIVE:

The purpose of this SOP is to lay down a procedure for sending sample for analysis to external laboratory.

  1. SCOPE: 

This SOP is applicable to Quality Control Department at manufacturing facility.    

  1. RESPONSIBILITY:
    1. Analyst or his designee shall be responsible for follow the SOP.
    2. The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
  2. PROCEDURE:
  1. The tests which can’t be done in QC laboratory, the sample send to approved external laboratory for analysis of sample. 
  2. Sufficient quantity (Approx twice analysis) shall be packed in double lined poly bag with label.
  3. The label on the sample shall include the name of the material/Product, Batch No., AR No., Manufacturing and Expiry Date, Sample Qty., Name of test, Prepared by (Sign/Date). 
  4. After packing of sample as per 4.2 and 4.3, the sample shall be inward in the External lab analysis tracking register as per Annexure-I.
  5. Additional verification of sample entry shall be made by Quality Assurance at the time of sending sample to External laboratory.
  6. After receipt of the sample result/report, the same shall be recorded in the Tracking register as per Annexure-I.
  7. The receipt report/result shall be reviewed by the QC Analyst for compliance of the result with Batch No./A.R. No. Name of test and result as per the specification.  
  8. TRAINING:

 Trainer : Head – Quality Control 

 Trainees             : Quality Control chemist / Sectional Heads

  1. DISTRIBUTION:

Controlled Copy No. 1:  Head of Department – Quality Assurance

Controlled Copy No. 2:  Head of Department – Quality Control

Original Copy     :  Head – Quality Assurance

  1. ANNEXURE:

            Annexure I : External Laboratory Analysis Tracking Register 

  1. REFERENCES(S):

Nil 

  1. REVISION HISTORY:
Sr. No.Revision No.Change Control NumberDetails of RevisionReasons(s) for Revision
100—-New SOPNew SOP










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