> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Elemental Impurities Guidance Needs Update: Glaxo
- URL: https://www.fdaweb.com/draft-elemental-impurities-guidance-needs-update-glaxo/
- Published: 2016-08-31T12:00:00.000Z
- Updated: 2026-09-14T21:28:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136675

GlaxoSmithKline says that while an FDA draft guidance on elemental impurities in drug products is a “well-written and informative document” that supports a risk-based approach to controlling elemental impurities, it is not up to date with respect to two U.S. Pharmacopeia (USP) chapters. “We assume that this lack of current alignment is due to the chronology of events,” the [comment letter](https://www.regulations.gov/document?D=FDA-2016-D-1692-0015&ref=fdaweb.com) says, “and that the revisions to USP general chapters 232 and 233 will be reflected in the final FDA guidance when it is issued.” Glaxo also says it welcomes the FDA statement in the draft that the agency anticipates that most approved products currently on the market in the U.S. do not contain elemental impurities that exceed the specifications in the relevant International Council on Harmonization (ICH) guidelines and USP chapter.

In its [comment](https://www.regulations.gov/document?D=FDA-2016-D-1692-0017&ref=fdaweb.com), the Generic Pharmaceutical Association (GPhA) asks for clarification on how FDA hopes or plans to align with other health authorities on the ICH document, particularly Health Canada’s requirement that finished drug product specification updates contain a statement confirming compliance with the ICH guideline. GPhA also asks for clarification if there is an expectation that drug testing be will done routinely as part of the risk assessment process. “The guidance seems to require product testing as proof/verification of elemental impurity levels evaluated as part of the risk assessment,” the letter says. “This requirement appears to be not aligned with the principles of risk assessment ICH Q9.”

In its [letter](https://www.regulations.gov/document?D=FDA-2016-D-1692-0019&ref=fdaweb.com), Sanofi asks for a table with implementation dates to avoid confusion with wording in a number of sections.

All three commenters also include specific line-by-line questions and recommendations.