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USP Joins Alliance for Safe Online Pharmacies

USP announced in a mid-August press release that it had joined the Alliance for Safe Online Pharmacies “to combat the threat posed by the illegal online sale of medicines.” The USP release notes that “nearly 97%” of online pharmacies that do not comply with applicable drug laws and standards.

Brazil Guidance on Track-and-Trace Requirements

Brazil’s regulatory authority ANVISA has published a guidance on the reporting requirements for its medicine track-and-trace system (see IPQ “News in Brief” January 31, 2014), which is due to come online in 2016. It specifies that transactions must be reported to the regulator by uploading XML files to its website detailing events such as packaging, […]

IPQ Monthly Update, July 2014

IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes....

India to Launch Nationwide Study on Substandard Drugs

The Central Drugs Standard Control Organisation (CDSCO) of India is set to begin a study on what areas of the country have a high concentration of substandard drugs. The study is intended to allow CDSCO to have a more focused investigation of the drug supply chain.

Rx360 Launches Traceability Work Group

Rx360 announced the establishment of a new collaborative work group in early August to “support serialization and track and trace legislation that is evolving globally.” The work group will focus on developing conceptual models for the interoperable exchange of information needed to comply with global regulations, and is seeking participation from anyone with knowledge of: […]

India Changes Date for Barcoding Implementation

India, in early August, extended its deadline for the barcoding of pharmaceutical packaging. The labeling being implemented is meant to aid in the track and trace of drug product in order to better secure the supply chain. The requirements for serialization were changed last month (IPQ “News in Brief” July 1, 2014) but the date for […]

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

Impax’ 483 in Taiwan Includes CoA Concern

A 483 issued to Impax Labs oral solid facility in Taiwan in late July underscores FDA’s current concern with overreliance on a component supplier’s certificate of analysis (see IPQ April 17, 2014 and July 27, 2014). Other of the 10 observations on the 483 address equipment validation, specification testing, rejection of OOS product, and process […]

FDA Cautioning Industry on Looming Initial Track and Trace Deadlines

FDA is cautioning industry stakeholders that the initial implementation phase for the track and trace provisions in the Drug Quality and Safety Act (DQSA) is rapidly approaching, with interoperable product transaction requirements for manufacturers, distributors, and repackagers kicking in on January 1, 2015....

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....
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