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PDA Technical Report on Single-Use Systems

In late September, PDA released its Technical Report 66 on single-use systems (SUS) that come in contact with materials used in drug production. TR 66 provides critical concepts when implementing an SUS strategy in the areas of: manufacturing strategy, system integration, qualification of suppliers and materials, business drivers, and implementation. The report also includes appendices […]

Amgen “Analytics of the Future” Initiative Develops MS-based “Multi-Attribute Methodology” to Streamline Biotech Development and QC Testing

Amgen is among the major biotech companies working hard on empowering, while at the same time streamlining, their analytical toolbox at the development and quality control testing levels as the next frontier of quality by design....

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, […]

EU GMP Chapters 3, 5, 8, Finalized

The EU Commission has published final versions of EU GMP chapters 3, 5, and 8, which will go into effect in March 2015. The drafts of the chapters were issued in early 2013. Chapter 3 on premises and equipment was revised to: ● emphasize the use of quality risk management (QRM) principles for cross-contamination when […]

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.

Guidance on Formal Dispute Resolution for CGMPs

In early August, FDA issued a comment request on its “Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.” The guidance is intended to provide information to manufacturers of human and veterinary drugs on how to initiate and resolve CGMP disputes (see IPQ October 30, 2013). […]

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: […]

Notice on India’s Regulatory Procedures

Following from a meeting discussing Indian regulatory standards, India’s Central Drugs Standard Control Organization (CDSCO) issued a notice in early August to all of India’s state drug controllers on the standards for conducting GMP inspections. Of note is the need for focus on using a risk-based approach for inspections of product development, quality, stability, process […]

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 […]
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