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APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....

FDA and Customs Announce “Trusted Trader Program”

In mid-June, FDA and the US Customs and Border Protection (CBP) announced the launch of a new “Trusted Trader” program meant to expedite the import of products made by companies that are known to meet a quality selection standard. Participants in the program will be given incentives such as exemption from “non-intrusive” inspections. To qualify, participants […]

WHO Releases Storage/Transport Supplements

WHO has released for review a set of supplements on its Technical Report Series, No. 961, 2011 Annex 9, which provides a “model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products.” The supplements cover: ● temperature and humidity monitoring systems for transport operations ● temperature and humidity monitoring systems for fixed […]

EC Publishes Q&A on GDPs

In late March, the European Commission published a “question and answers” (Q&A) related to its new guideline on Good Distribution Practice for medicinal products for human use, which went into effect in November 2013. The document contains 25 Q&As. The questions focus on: ● competence and training of personnel ● segregation of products ● temperature […]

FDA Implements ICH Photosafety Evaluation Guideline (S10)

In early February, FDA announced its implementation of ICH’s photosafety evaluation guideline (S10). The guideline addresses the toxicity resulting from drug exposure to light. In order to better address safety concerns, a distinction has also been made between phototoxicity and photoallergy.

USP Proposes Revision on Temperature Control During Storage and Distribution

USP has published a “stimuli article” in its Pharmacopeial Forum (PF) proposing revision of the current USP chapter regarding the temperature at which specific pharmaceutical products can be distributed and stored. Current stability studies, the PF article maintains, support significantly widening the range to 2-30º C from 15-25º C or 20-25º C.

Comment Process on FDA’s Proposed Rule on Product Detention During Inspections Reflects Industry Support

The comment process on FDA’s proposed rule on “Administrative Detention of Drugs Intended for Human Animal Use” as authorized under Title VII of the FDA Safety and Innovation Act (FDASIA) has indicated industry’s comfort level with extending the detention authority the agency already had for foods and devices to drug products....

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....

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....

API Switch in OTC Cough Syrup Kills at Least 60 in Pakistan and India

The World Health Organization (WHO) reported in an “information exchange system alert” issued in late January that cough syrup manufactured in India using an incorrect raw material has resulted in the deaths of at least 60 people in Pakistan and India. The incidents occurred in November and December and were linked to cough syrup produced […]
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