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Elemental Impurities – Highlights of the Coming Regulation

Replacement of the wet chemistry “heavy metals” limit tests with more modern analytical methodology and conformance to new and specific limits for individual elements was a dramatic, although anticipated, change in the regulation.

The ICH recognized that prior to the Q3D Guidance, regulation of elemental impurities fell under Guideline Q3A for inorganic impurities. Existing pharmacopoeial procedures included the Heavy Metals test, Residue on Ignition/Sulfated Ash test and other wet chemistry tests. The problem with these procedures was that they were non-specific and were never intended to detect the low-level residual metal catalysts and reagents used in some modern synthetic processes. In addition, the acceptance criteria were based upon historical precedent and, although risk factors for metal contamination had changed significantly throughout the 20th century, the existing limits had not changed accordingly and had little toxological basis.

Topics: Regulatory Compliance

Elemental Impurities: The Risk-Based Approach

The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> by January 2018. Although the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. The USP requires Plasma Spectrometry (ICP-MS or ICP-OES) as the technique to screen and/or accurately quantitate the presence of any elemental impurities of interest.  From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product.  There are currently two strategies to meet the requirements for elemental impurities, with the first being a Risk-Based approach.

Topics: Regulatory Compliance

Elemental Impurities: Updated Regulatory Requirements

In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for Elemental Impurities, which replaced wet chemistry "heavy metals" limit test, such as USP <231>, with new analytical technology, specifically inductively coupled plasma (ICP) - based technologies, and mandated conformance to new and specific limits for individual elements. This action by the ICH triggered prompt reactions by the U.S. Food and Drug Administration (FDA), United States Pharmacopeia (USP) and European Pharmacopeia (EP) to harmonize with the ICH requirements.

Topics: Regulatory Compliance

Serialization and Track and Trace

Are you ready for the new regulatory requirements for Serialization and Track and Trace scheduled to take effect in November of 2017?  Our recent upgrades to packaging lines for full serialization and aggregation capability can support your organization’s transition to providing product that is fully compliant with the new regulations. Get prepared by partnering with us!  

Learn more about the important changes to Serialization and Track and Trace Requirements:

Download Serialization and Track and Trace Overview

Topics: Regulatory Compliance