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Revision of GMP “Orange Guide” Issued by MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a revision of its GMP “Orange Guide” in January that incorporates the changes made to EU’s GMP Guide in the wake of the Falsified Medicines Directive (FMD). Included are new chapters regarding brokers of finished medicines and active substance manufacturers, distributors and brokers, along with […]

APEC Supply Chain Regulatory Harmonization Effort Gaining Traction

The Asia Pacific Economic Cooperation (APEC) organization is developing and implementing a five-year plan cutting across GMPs, GDPs, pharmacy practices and Internet sales that could have a powerful influence on global regulatory harmonization in the pharmaceutical supply chain arena....

U.S. and Five Other Countries Await Listing Decision Under EU’s Falsified Medicines Directive

The U.S. is among six countries with applications pending at the European Commission (EC) to be listed as a third country with GMPs equivalent to those in force in the EU, which allows continued export of active pharmaceutical ingredients (APIs) into the EU without a company-specific certification under the terms of the EU’s Falsified Medicines […]

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

Alleged Use of “Gutter Oil” to Produce Antibiotic Intermediate in China Probed

The government of Central China’s Jiaozuo city sent a team in early September to a subsidiary of Joincare Pharmaceutical Group to investigate allegations that the firm is manufacturing an antibiotic intermediate using reprocessed cooking oil, called “gutter oil,” China Daily reports. China’s State Food and Drug Administration (SFDA) announced that it would investigate the truth […]

USP Releases New Draft General Chapter on Good Distribution Practices and Supply Chain Integrity

USP has released for comment a new draft general chapter <1083> titled “Good Distribution Practices – Supply Chain Integrity” that will be expand its series of information chapters addressing various aspects of the pharmaceutical supply chain. The formal proposal will be published in March/April issue of Pharmacopeial Forum.  Comments are due by May 31. An advance […]

Hydrochloric Acid Shortage Prompts Testing of Incoming Shipments

A recent shortage of technical grade hydrochloric acid (HCl) is beginning to impact the supply of high purity HCl used in pharma manufacturing, according to the supply chain consortium Rx-360.  It has confirmed the shortage condition and notes that there have been recent reports of specification failures of HCl tested at incoming inspection at some […]

Pharma Purchasing and Outsourcing Approach Needs Overhauling, Supply Chain Expert Asserts

Regulatory pressure and “true cost” understanding will push pharmaceutical firms to reverse the current outsourcing trend and gain back more control of their critical ingredients and components, supply chain expert Andrew Cox asserts....

Congressional Bills Address FDA Supply Chain Oversight

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Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD

The complex issues around glass quality and drug product interactions bring into high relief the need for container suppliers to be directly involved in the implementation of quality by design (QbD) for injectables....
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