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IPQ Monthly Update — May, 2013

The IPQ "Monthly Update" for May is now available. Read this story for a concise summary of its contents.

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....

The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum

The sterility control challenges that pharmacy compounding presents stretch from practitioners trying to handle continually changing procedures and preparations, to the laboratories trying to do quality control testing in the context of these shifting targets and sample constraints, to the array of distribution and storage avenues – and limiting the risks rather than eliminating them should be the goal, participants at a US Pharmacopeia (USP) forum agreed....

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

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 […]

SFDA Releases Revised “Good Supply Practices” Guideline

China’s State Food and Drug Administration (SFDA) has released a revision of its good distribution practices guideline – which SFDA terms “good supply practices” (GSPs) – that will take effect at the beginning of June. Firms will have three years to come into full compliance.  After that time, non-compliant firms will no longer be able […]

FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

A review of the initial results from an inspection blitz of about 30 high-volume sterile pharmacy compounding operations nationwide launched by FDA in late February shows a clear pattern of weakness in their sterile practices including environmental monitoring, gowning, personnel practices and sterility/endotoxin testing....

Debate Continues Among Stakeholders on Framework for Regulating Pharmacy Compounding; Legislative Options Reviewed at FDLI Forum

Congress, FDA, and the states, together with a wide mix of other stakeholders, are wrestling with how to define a more viable and coherent model for regulating pharmacy compounding – where the boundaries should be placed between state and federal oversight and what the respective regulatory structures and rules should look like....

India Publishes Guidelines for API Export into the EU Under the FMD

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has released procedures from the country’s Central Drug Standards Control Organization (CDSCO) for how Indian active pharmaceutical ingredient (API) manufacturers can obtain a written confirmation of quality that will be needed to ship their products to the EU. Pharmexcil, which was set up by India’s Ministry of […]

QP Review of More Complex Supply Chains and Applications, EU Member State Differences, Among Issues Facing EMA in Annex 16 Revision

EMA’s GMP/GDP Inspectors Working Group (IWG) is wrestling with how to build into EU GMP Annex 16 the assurance that the Qualified Person (QP) understands the complexities of a globalized supply chain in certifying that a batch complies with GMP/GDP requirements and the new mandates of the Falsified Medicines Directive (FMD)....
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