ELEMENTAL IMPURITIES BY ICP/MS
How will your drug fare against the new ICP/MS tests?
"The phase-out is going to affect just about everyone from regulatory on down to the 3rd party labs, and there are some very important points associated with this new testing scenario that every quality control manager should be aware of.”
What's the biggest risk?
Without a doubt, the highest risk comes from waiting. Waiting to start ICP/MS testing for new product development. Waiting to update tests for NDA and ANDA filings. Even waiting to re-test existing products can cause major delays.
“So many products that are in the market today will need to be re-tested…and with the new levels the FDA allows, and the sensitivity of the machinery, there’s a very good chance that compound will fail the test.” says Browning.
“I’m just not sure what everyone is waiting for. Truthfully, if you re-test now, you’ll have time to remediate most any problem. But we see so many companies just letting the days go by and they just don’t see the deadline as an oncoming train.”
For over 100 years, the elemental analysis "heavy metals limit test" by USP has been the industry standard. The Pharmaceutical Industry - under the guidelines set by the ICH (International Conference on Harmonisation) and the USP (United States Pharmacopeial Convention) - is moving to adopt the use of ICP/MS (Inductively Coupled Plasma/ Mass Spectrometry) for the determination of elemental impurities in new finished drug products, new drug products containing existing drug substances, and excipients.
The USP will replace the current General Chapter HEAVY METALS with the following two, new general chapters:
- General Chapter ELEMENTAL IMPURITIES - LIMITS, which addresses the limits of elemental impurities (heavy metals) using antiquated methodology;
- General Chapter ELEMENTAL IMPURITIES - PROCEDURES, which addresses the procedures to be used when analyzing the elemental impurities (heavy metals) using state of the art ICP/MS.
The USP allows companies to switch from the old, General Chapter to the new, General Chapters and at any time up to the time of mandatory implementation. The change in test procedure does not require a separate filing with the FDA (Federal Drug Administration). It can be documented in the NDA/ANDA (New Drug Application/Abbreviated New Drug Application) Annual Report, per the FDA Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports:
4.2. "Change to the specification for a drug substance, drug product, or pharmacopeia excipient that is made to comply with the official compendia if it is a change that does not relax an acceptance criterion or delete a test."
Heavy Metals Compliance Checklist
There’s more to know about ICP/MS than just the January 1st deadline. We’ve compiled a list of points that are essential for anyone associated with quality control and compliance who needs to manage their product life cycle more efficiently.
The list includes: Who is affected by the change and Why both old and new drugs are at risk.
Register below and we will email you the complete list, or call 973-361-4252 to speak with an expert.