High Utilization Seen as GMP Issue Behind Cancer Drug Shortages / A lack of manufacturing capacity blamed for sterile injectable oncology drug shortages can be viewed as a GMP compliance issue, FDA official says, pointing to Section 211 process validation requirements. HHS analysis links the shortages to excessive utilization rates at generics firms. / “The Gold Sheet” May 2012
Drug Shortages Proposal From Sen. Hatch Offers 7-Year Economic Incentives / The Utah Republican’s draft bill would encourage industry to increase its capacity to manufacture sterile injectable drug products by providing higher reimbursement rates and exclusivity incentives. House Republicans continue to pursue economic options, but time and jurisdictional factors could work against such measures to address shortages. / “The Gold Sheet” May 2012
China Drug Safety Remains Front and Center In Chromium Capsule Scandal / China’s latest product safety scandal could have far-reaching implications, potentially even disrupting China's tendering system for essential medicines. / “The Gold Sheet” May 2012
Inspectorates Share QRM Tools to Protect Quality from Downsizing / Quality risk management is touted as the key to preventing, or if needed, preparing for the brain drain that can affect drug quality when a plant loses key personnel due to staff cuts. PIC/S encourages drug makers to try the QRM tools its members use when inspecting plants. / “The Gold Sheet” May 2012
USP Still Has a Long Way to Go in Updating Excipient Monographs / U.S. Pharmacopeia officials say they have only modernized about 10% of the excipient monographs deemed a high priority in need of modernization by FDA and have received “minimal” input from industry in updating outdated monographs. / “The Gold Sheet” May 2012
ICH Q11 Accord Brings QbD to APIs, Defines API Starting Materials / After five years, working group members of the International Conference on Harmonization have adopted its Q11 guideline on drug substance development and manufacture, which advances QbD principles for drug substance development, especially for biotechnology products, endorses the use of prior knowledge, and establishes a harmonized definition for starting materials. Even though not everyone is happy with this definition, ICH members say that a harmonized definition is better than a non-harmonized one. / “The Gold Sheet” May 2012
With July 2013 Deadline Looming, Debate Continues Over How to Require GMPs for APIs in Europe / As Europe prepares to subject API imports to GMP controls, industry urges a different approach. Questions linger over how to keep Anti-Falsification Directive from drying up Europe’s API supplies. / “The Gold Sheet” May 2012
China Expands GSP To Clarify Drug Distribution Roles / China’s Ministry of Health recently released a good supply practices (GSP) draft that would expand the rule from 88 articles to 201 articles; public comments close May 27. / “The Gold Sheet” May 2012