This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
|Articles|April 1, 2010
Regulatory Roundup: WHO Releases Draft Guideline For Production And Control Of Specified Starting Materials.
Author(s)Pharmaceutical Technology Editors
WHO Releases Draft Guideline For Production And Control Of Specified Starting Materials.
Advertisement
Regulatory Roundup
According to a release from Rx-360, the international pharmaceutical supply-chain consortium, the World Health Organization has released for comment a draft guideline for the production and control of specified starting materials. The draft, currently released to only a specified audience, defines starting materials as “any substance which is primarily or mainly used as a starting material for the production of an API [active pharmaceutical ingredient], but which itself could be used directly as an API” and notes that the specified starting material should therefore “conform to the existing monograph in a recognized pharmacopeia.” If the material is to be used for API production, however, then the “quality attributes and specifications should be determined by the API manufacturer” and the product’s intended use, according to RX-360’s release on the guideline. Quality control for starting materials should include test for impurities, isomers, residual solvents, and other impurities and take a risk-based approach. The consortium has a full summary on its
Advertisement
Related to this article
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Advertisement
Advertisement