OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Commerce. All rights reserved.
Company plans to certify locations worldwide for medical devices and clinical trial materials
MNX (Los Angeles), which has been building up its life-sciences service business for the past several years, has jumped on the GDP bandwagon—but in a more thoroughgoing way than some other third-party logistics (3PL) providers. The company contracted with SGS, an international testing, validation and certification organization (US HQ: Rutherford, NJ) to certify its Singapore station as meeting GDP standards for storage, transportation and kitting of medical devices and clinical trial materials (CTMs), including temperature-controlled products. Other MNX locations, including Melbourne, Tokyo, Shanghai, Beijing, New Delhi, Frankfurt, Los Angeles and a recently opened depot in Sao Paulo, are also scheduled to be so certified.
Onno Boots, managing director, Asia-Pacific for MNX, says that the company had already received ISO certifications for many of its operations, “and the GDP standards are generally only an extension of those standards.” He adds that the company life sciences business is the fastest-growing of its service sectors, which include aerospace and the entertainment industries. “We’re winning life sciences business by positioning ourselves as more specialized than the major international logistics integrators, yet providing a broader range of capabilities as compared to the specialized courier companies that handle CTMs. We work both with major pharma companies and with the clinical research organizations that hire them.”
GDP standards, codified over several years in the European Union, entail a range of monitoring, training and quality assurance processes for life sciences materials, especially those that require temperature-controlled (cold chain) service. Nominally, the standards apply both to the manufacturers of such products, as well as 3PLs, cargo carriers, freight forwarders and others involved in cargo handling. Some companies have internal training and quality assurance processes that mirror the GDP standards, and some “self-certify” by their own internal reviews. Whether self-certified or certified by a licensed third party, however, ultimately the product owners themselves are responsible for overall logistics quality, and thus often perform their own audits.