The purpose of this SOP is to lay down a procedure for sending sample for analysis to external laboratory.
This SOP is applicable to Quality Control Department at manufacturing facility.
- Analyst or his designee shall be responsible for follow the SOP.
- The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
- The tests which can’t be done in QC laboratory, the sample send to approved external laboratory for analysis of sample.
- Sufficient quantity (Approx twice analysis) shall be packed in double lined poly bag with label.
- 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).
- 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.
- Additional verification of sample entry shall be made by Quality Assurance at the time of sending sample to External laboratory.
- After receipt of the sample result/report, the same shall be recorded in the Tracking register as per Annexure-I.
- 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.
Trainer : Head – Quality Control
Trainees : Quality Control chemist / Sectional Heads
Controlled Copy No. 1: Head of Department – Quality Assurance
Controlled Copy No. 2: Head of Department – Quality Control
Original Copy : Head – Quality Assurance
Annexure I : External Laboratory Analysis Tracking Register
- REVISION HISTORY:
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|1||00||—-||New SOP||New SOP|