Manufacturing

Articles

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online. 


FDA Sweeps Websites with Warning Letters

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components. 

FDA Issues Warning Letter to EpiPen Manufacturer

Agnes Shanley is senior editor of Pharmaceutical Technology.

The Portable, Continuous, Miniature, and Modular (PCMM) collaboration is alive and well, and the second generation of its modular continuous manufacturing equipment is now available.

PCMM, The Next Generation

It’s time to stop talking about “anticounterfeiting,” and move to integrated, collaborative supply chain security, experts say.

From Reactive to Proactive Supply Chain Protection

Emerging anticounterfeiting technologies offer pharmaceutical manufacturers more options for supply chain security. 

A Growing Number of Options

The agency published guidance on identifying trading partners under DSCSA.

FDA Releases Supply Chain Guidance

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

Trek Therapeutics to Test Blockchain-Based Smart Contracts for Clinical Supply Chain Safety

Marco Anelli is R&D Director of ProductLife Group.

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

Understanding the Potential of Artificial Intelligence Across the Pharmaceutical Lifecycle

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

Drug Supply Chain Tracking Challenges FDA and Manufacturers

Cryopak’s CryoCube reusable temperature-controlled shipping systems are available in several insulation categories, and a tailored solution can be modeled using thermal modeling software.
