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IPQ Monthly Update, July/August 2013

The IPQ Monthly Update for July/August 2013 is now available....

FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....

Burden of Pre-Inspection Submission Requests from Agencies Outside the US and Europe is Growing

Pharma industry experts are expressing concern with a new trend of emerging country agencies requesting significant amounts of manufacturing and facility information prior to performing GMP inspections and are proposing that the international community work toward a more clearly-defined, manageable and harmonized approach....

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....

IPQ Monthly Update — April, 2013

The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come....

ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership

Singapore is leading an effort by the Association of Southeast Asian Nations (ASEAN) to achieve a harmonized approach to process validation modeled on FDA’s lifecycle approach and the ICH Q8-10 paradigm it embodies....

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 […]

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 […]
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