LIVE FROM PDA/FDA: Compliance to Quality: Part 1
This article does not discuss cold chain specifically, however the discussion about the Center for Drug Evaluation and Research (CDER), the Office of Pharmaceutical Quality (OPQ), and the Emerging Technology Team (ETT) is interesting and could be relevant to BioPharma cold chain:
CDER’s Office of Pharmaceutical Quality aims to establish a collaborative approach with manufacturers to encourage innovation and the adoption of new technologies.
According to Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, quality is “defined as a product that reliably delivers the therapeutic benefit promised on the label to the patient and is free of contamination.”Every day, people are taking medication and without even realizing it, they’re making assumptions about the quality of the product. Patients assume their drugs are efficacious, that they have the correct identity, that they’ll receive the same drug performance as described on the label, that they are made in a manner that ensures quality and that they will be available when needed. But, in reality, two-thirds of drug shortages are due to quality issues and drug product recalls are increasing.Enter the Office of Pharmaceutical Quality (OPQ), a single unit of the CDER. The priority of the OPQ is to establish a collaborative approach with manufacturers to encourage innovation and the adoption of new technologies. Dr. Michael Kocha, PhD, RPh, Director, Office of Pharmaceutical Quality, CDER, FDA, presented a regulator’s perspective on compliance to quality at the PDA/FDA Joint Regulatory Conference in Washington, DC.
Source: Logistics for the LifeSciences
