SOP on Assessment of Contract Analytical Laboratory for Qualification
Objective : To lay down a procedure for Assessment of Contract Analytical Laboratory for qualification.
Scope : This Standard Operating Procedure is applicable for qualification of Contract Analytical Laboratory for analysis of samples for which in-house testing facility is not available.
Responsibility : Heads of Quality Control and Quality Assurance shall make assessment and approval of the contract analytical laboratory as per procedure mentioned in this SOP.
Head, Operations or his designee shall authorize the laboratory for contract analysis.
Abbreviations and Definitions
Contract Acceptor – The contract analytical laboratory who shall analyze samples on contract basis.
Procedure : Head-Quality Control or his/her designee shall initiate qualification of contract acceptor by sending “Questionnaire for Evaluation of Contract Analytical Laboratory” to the prospective laboratory.
Head-Quality Control, after receiving the filled form “Questionnaire for Evaluation of Contract Analytical Laboratory” from the Contract Analytical Laboratory, shall evaluate and forward it to Head-QA or his/her designee with comments, if any.
Head-QA or his/her designee shall evaluate the questionnaire and see, if the site audit of the contract acceptor is required or not. The site audit shall be planned along with Head-QC or his / her designee.
If site audit is required, the representative of contract giver shall intimate the contract acceptor well in advance.
On the basis of audit’s findings and/or Questionnaire for Evaluation of Contract Analytical Laboratory, Head-QA shall decide the approval of Contract Acceptor.
If Contract Acceptor qualifies for approval, then Head, QA shall forward the Specimen – Written Agreement, if applicable, to Manager, Intellectual Property Rights and Legal Affairs for guidance purpose and preparation and signing of written agreement.
Manager, Intellectual Property Rights and Legal Affairs shall provide a copy of written agreement to QA and QC.
Then Head, Operations or his designee shall dispose the form “Certification – Qualification of Contract Acceptor”.
Master copy of “Certification – Qualification of Contract Acceptor” shall be maintained at QA and a copy shall be provided to QC.