Hedman described the TB environment as “fairly high-risk” with respect to the impact of shortfalls in quality, citing factors such as disease severity, challenges in patient follow-up, length of treatment, and the multiple drug regimens of MDR TB treatment as compounding the opportunities for drug failures. Few high-burden countries currently have (or are close to having) the capacity for pharmacovigilance, that is, the capacity to “monitor the quality of the medicines being made or imported,” an important component of stringent regulation.

Andreas Seiter, Senior Health Specialist, Pharmaceuticals, Health, Nutrition, and Population, World Bank, suggested that a key barrier to QA in pharmaceutical procurements is that existing and established QA processes are not enforced. He cited the example of quality tests in pre- and post-shipment inspection and testing that are required in the contract but are not carried out.

Christophe Perrin, QA Pharmacist, The Union, remarked that double standards in the manufacture of SLDs exist as a result of variability in the stringency of regulatory authorities and in producers’ commitments to quality. He cited anecdotal evidence that TB drug producers “are playing with some of the standards of what is inside a tablet” by using inadequately QA API for their FPPs. Andrew Gray, University of KwaZulu-Natal, expressed similar concern that some manufacturers, particularly large firms, might have WHO PQ status and adhere to stringent quality standards in only one of multiple plants that are producing the same drug.

National-Level QA

Noting that no international mechanism can “police” for QA if countries do not take ownership of the process, Keravec said the responsibility for QA should be transferred to countries. Countries should be supported to establish more stringent QA policies and procedures along with a mechanism for reporting problems that are detected, he added. Indeed, a strong in-country QA process should be able to detect production problems, including those of WHO PQ products when they arise. David Ripin, Executive Vice President, Access Programs, and Chief Scientific Officer, CHAI, agreed that moving countries toward self-regulation of products is important, and an important component of that ownership is agreement on bioequivalence for global products. Not all countries require bioequivalence as part of their QA programs, which might contribute to fragmentation of the market among drugs manufactured to satisfy different definitions of quality. Ripin expressed concern that many smaller countries need to rely on a common standard of quality, and that as countries move toward their

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