Draft guidance published by the FDA in 2016 concerning the control of elemental impurities of human drug products marketed in the United States, gave advice representing the soon to be final view of the topic by the Food and Drug Agency.
ICH Q3D, for example, provides recommendations for manufacturers of human drugs and biologics for applying risk based approaches to control elemental impurities and PDE. In essence, all known and potential sources of elemental impurity must be risk assessed, and if necessary, controlled. From lab to sterile tableting, from glass RB flasks to blister packaging, the whole process must be considered.
Specifically, chemical processes which employ use of transition metal catalysts are subject to this scrutiny. Palladium is one of the most commonly used catalysts, which is often found present at low levels in downstream products, if not treated or removed. Because these impurities do not contribute to a drug's therapeutic effect, and in some cases can cause patients harm, FDA and other regulatory bodies have developed guidelines to measure and control the presence of these impurities.
Biotage is a leading supplier of highly efficient metal scavenging adsorbents to Pharma for over 15 years and has developed a comprehensive self-guiding screening kit and documentation package for metal scavengers, to help clients stay current and future proof their processes in the face of these changing times and regulation.
Biotage Metal Scavengers are proven to reduce metals in order to help comply with latest regulation, but operating on a technical level is not enough for this fast paced industry. Each metal scavenger is backed up by no less than 8 industry leading certificates covering compliance of the product and place of manufacture with a number of internationally recognized quality, environmental and ethical standards:
While both ICH Q3D and USP General Chapters <232> and <233> are scheduled to be in effect in 2018, FDA says it encourages manufacturers to comply with the standards as early as possible, as they "provide significant improvements over existing approaches."
For more information about staying ahead of the compliance curve, contact your local Biotage representative.
Extraction of Desmopressin from Serum Using EVOLUTE® EXPRESS WCX Prior to LC-MS/MS Analysis
White Paper: Reduce Solvent Use by 50%
Perfecting Your Mass Spectrometer Parameters
Sample Preparation Strategies for Urine Panels with 50 Drugs
Biotage Synthesizer Peer-reviewed Literature