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Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....

China to Implement Drug Distribution Reforms

China’s State Council stated in late February that it would implement drug distribution reforms. According to a Reuters report, this effort is designed to reduce substandard and counterfeit drugs through centralization and ensuring legitimate products reach rural areas.

Comment Review, Public Meetings, Supply Chain Pilot to Follow 2014 Bolus of FDA DQSA Track & Trace Guidances

In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain....

New MHRA Orange and Green Guides

MHRA released the latest edition of its Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors) and Green Guide (Rules and Guidance for Pharmaceutical Distributors) in early January. The Orange Guide now includes sections on MHRAs: ● Innovation Office • Compliance and Action Group • risk-based inspection program • gold standard for Responsible Persons, […]

Three FDA Guidances on Drug Supply Chain Security Act (DSCSA)

In late November and December, FDA issued three more guidances on implementing the provisions of DSCSA – the track and trace (Title II) component of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). Title I of DQSA addresses compounding. The three new DSCSA guidances cover:● the situations in which FDA will delay […]

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, […]

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 […]

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....
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