Supply Chain

The sequence of processes involved in the production and distribution of a commodity. A supply chain normally encompasses the following three functions:-Supply of materials to a manufacturer;-The manufacturing process; and,-The distribution of finished goods through a network of distributors and retailers to a final customer.Companies involved in various stages of this process are linked to each other through a supply chain.

Technical

Pandemic-related supply chain shortages have placed constraints on the supply of essential filters and chromatography resins. An agile regulatory pathway to implement alternative filters and resins into manufacturing is necessary to ensure the continued supply of approved biologics. To allow this in the US and potentially globally, the regulatory strategy proposed in this article is to provide...

iSpeak Blog

ISPE is a global industry leader in scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. As a result, ISPE is in a strong position and available to assist the US government, its allies, and like-minded regulatory partners with implementation of recommendations emerging from a report,

Features

The current regulatory framework in the pharmaceutical industry places pressure on marketing authorization holders (MAHs) to demonstrate quality oversight, and a systematic risk management process is a prerequisite for avoiding compliance and productivity pitfalls. This article focuses on options to improve day to- day operations and to ease decision-making by integrating operational risk...

Features

Biopharmaceutical supply chains are undergoing dramatic changes that will affect the design and operation of the facilities of the future. Predominant among these is the shift away from primary care to specialty products and personalized medicine, and from large-scale production of low-value small molecules to low-volume, high-value biologics.

Technical

India is a worldwide leader in drug manufacturing, producing 10% of global pharmaceuticals, with 2016–2017 exports valued at $16.4 billion.1

  • 1RxGPS: The Alliance for Global Pharmaceutical Serialization. "Implementing India's Drug Serialization and Traceability Requirements to Advance Patient Safety and Support Global Trade." White paper, May 2017....