This document details the procedure for handling the testing carried out outside Xyz Limited laboratory. It is the policy of Xyz Limited that written procedure shall be followed for handling the external testing to ensure that results provided by the external agencies are reliable and can meet the regulatory requirement and/or In House Specification of Xyz Limited
This document is applicable at the time of sending the material for testing outside Xyz Limited laboratory.
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3.0 RESPONSIBILITY
Persons along with their responsibilities are given below:
Executive - Corporate Quality Assurance:- To prepare and follow the SOP accordingly. Maintain the record as per SOP.
Manager - Quality Assurance:- To ensure implementation of SOP.
Manager - Corporate Quality Assurance:- To ensure implementation of SOP.
4.0 PROCEDURE
5.1 GENERAL
4.1.1Â A material can be tested at another unit or an outside laboratory due to the non-availability of instrument/equipment/ facility or for confirmation of results, after getting permission from desired personnel.
5.1.2Â The records of the sample shall be maintained as per Annexure (Logbook Format) and a record file with corresponding details shall be maintained. Â Â
4.1.3Â The testing laboratory must be accredited by NABL and approved by the government. The testing laboratory shall also be approved by XYZ Company before sending any sample to the external laboratory.
4.1.4 A preliminary Questionnaire as per XYZ/CQA/SOP-012/FR-01, Appendix (Questionnaire) for approval of external laboratory shall be sent to the testing laboratory.
4.1.5 Review the completed questionnaire received from the testing laboratory.
4.1.6 Manager-Quality Control / Manager Technical shall review the filled questionnaire.
4.1.7 Manager-Corporate Quality Assurance / Manager Quality Assurance shall evaluate and decide whether the audit of the testing laboratory is required or not.
4.1.8 Manager – Corporate Quality Assurance / Manager Quality Assurance can take the decision for approval on the basis of the filled questionnaire.
4.1.9 If the audit of the testing laboratory is required, qualified personnel (suitable experience and qualification) shall conduct the audit of the testing laboratory.
4.1.10Â The auditor(s) shall follow the guidelines as per XYZ/CQA/SOP-012/FR-02, Appendix (Testing Laboratory Audit Guidelines) but not limited to the guidelines.
4.1.11Â After the audit, minutes shall be prepared by the audit team and forwarded to the management for the decision of approval as per XYZ/CQA/SOP-012/FR-03, Appendix (Testing Laboratory Approval Sheet) of the concerned laboratory.
4.1.12Â If the concerned testing laboratory is approved, the representative of the Xyz Limited and the concerned testing laboratory shall sign a contract as per XYZ/CQA/SOP-012/FR-04, Appendix (Quality Contract).
4.2Â ISSUANCE OF SAMPLE FOR TESTING
4.2.1 Collect sample, sufficient quantity of material for two times analysis.
4.2.2 Pack the sample in a self-sealing poly bag and label the sample with the following information on the container like Item, M.R. No., Batch No., A.R. No., Quantity of sample, Sampled on (Date & Time), Sampled by (Signature), etc.
4.2.3 Ensure that the sample is air-tight when packed and packing is safe enough to face the stress of transportation.
4.2.4 Quality Control department shall prepare a letter for analysis and mention the tests to be carried out along with the specifications or monograph of pharmacopeia to be followed for testing.
4.2.5 The letter for analysis shall also have the sample details like Name of Sample, Pharmacopoeia name, Batch No/ Lot No., Mfg. & Exp. Date, Name of Mfg., Batch Size / Qty. received Sample quantity, or any other Specific information, etc.
4.2.6 If the sample is sent for a specific test for which an in-house facility is not available, do not approve and provide the certificate of analysis of the material until and unless the test report of passing the test is not received from an outside testing laboratory.
4.2.7 If the test house asks for any Working Standard/ Impurity or both for testing needs, the Quality Control department shall make arrangements to provide the same to the testing laboratory.
4.2.8 If Company does not have mentioned Reference Working Standard, the test house shall make its own arrangement.
4.2.9 Check the results on the test report and if the results are not within the limit of Specifications inform Manager Quality Control.
4.2.10Â Investigate the reason for the failure of a sample, whether the test failure was due to poor material Quality or because of accidental contamination or Quality deterioration during transportation of sample, if required send the second sample after re-sampling and ensure safe submission of the sample.
4.2.11 Prepare a list of an approved testing laboratory as per Xyz/CQA/SOP-012/FR-05, Appendix (List of Approved Testing Laboratories).
TESTING LABORATORY AUDIT GUIDELINES
During the audit, consider the following points but are not limited.
Are specifications available for raw materials and finished products and packing materials?
Are the equipment calibrated and validated?
Are the products analyzed as per the standard methods?
Are the volumetric solutions standardized?
Is the glassware calibrated?
Are the reference standards and working standards available and records maintained?
Are instrument logbooks maintained?
Are the analytical reports prepared and maintained for all analyses?
Staff Training: Is adequate training provided to the testing staff and records maintained?
Internal Audit: Is adequate Internal Audit procedure in place and records maintained?
Change control procedure: Is the change control procedure properly documented?Â
QUALITY CONTRACT
1.    Name of Testing Laboratory  :
2.    Address                                :
3.    Clauses of Contract               :
Testing laboratory ensures that all tests shall be supported by the chromatograms (wherever applicable). Certificate of Analysis in duplicate shall be furnished on letterhead of the Testing Laboratory. All the tests shall be carried out by Pharmacopoeias methods and/or standardized test methods.
Specifications and test methods shall be provided by XYZ Limited in case the product is not compendia. The approved laboratory shall not give the samples to a third party without written information to Company name change is allowed in the established procedure.
The testing laboratory shall provide a quotation and mode of payment for the testing charges. Any change in the testing procedure shall follow the change control procedure.
For (XYZ Limited)                For (……………………………)
Authorized Signatory           Authorized Signatory
>Procedure for collection, storage, and withdrawal of Retained/ Reference samples.
