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THE PHARMA REVIEW (JANUARY - FEBRUARY 2012)

Contract Testing Lab Selection Top 10 Points to Consider

Saurabh Arora

Abstract: The testing lab you partner with can make or break your reputation in the market, because they determine the quality of your products and their compliance to relevant regulatory standards. Giving the responsibility of your product quality and hence your market image to the right partner is a crucial decision. Based on feedback from clients from around the world we have compiled a list of top 10 points you must consider when selecting a testing lab to partner with.

 
Accreditation
Working with an accredited laboratory significantly reduces the guess-work and risk for you and helps satisfy the regulators. The globally accepted standard for testing laboratories is ISO/IEC 17025, it lays down the general requirements for comprehensive quality management system. To get the accreditation testing labs have to establish a standardised quality system which ensures the quality, and traceability of the results produced by the lab. An accredited testing lab is regularly audited by trained experts from the industry to verify compliance the standard, so even if you are not an expert at auditing the lab you can rest assured their systems and processes are audited by experts and are of a global standard. A lot of regulatory bodies have accepted this as a minimum requirement for approving a laboratory and even US FDA has issued a draft guidance on accepting abbreviated data packages from accredited laboratories.
 
Regulatory approvals
Before you select a testing lab you must make sure that they are approved by the relevant regulatory bodies so that the data generated by them is acceptable to your regulators. For example if you are working in the pharmaceutical industry in India the lab must be approved by the drug control department to issue reports on Form 39 of the drugs and cosmetics act. If you are exporting food products the testing lab must be approved by APEDA and the Export Inspection Council of India. Like this each industry has its own regulators that must have granted prior approval to the laboratory, a list of regulators that have approved our lab is given on our accreditation and approval page.

 

 

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