Q3D(R1) elemental impurities
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Contamination -- prevention & control Quality Control United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits. There are three parts of this guidance: (1) The evaluation of the toxicity data for potential elemental impurities. (2) The establishment of a permitted daily exposure (PDE) for each element of toxicological concern. (3) The application of a risk-based approach to control elemental impurities in drug products. An applicant is not expected to tighten the limits based on process capability, provided that the elemental impurities in drug products do not exceed the PDEs. The PDEs established in this guidance are considered to be protective of public health for all patient populations. In some cases, lower levels of elemental impurities may be warranted when levels below toxicity thresholds have been shown to have an impact on other quality attributes of the drug product (e.g., element-catalyzed degradation of drug substances). In addition, for elements with high PDEs, other limits may have to be considered from a pharmaceutical quality perspective and other guidances should be consulted such as the ICH guidance for industry Q3A(R2) Impurities in New Drug Substances (June 2008) (ICH Q3A(R2)). This guidance presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in the ICH guidance for industry Q9 Quality Risk Management (June 2006) (ICH Q9).4 This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (80 pages))
- Edition:
- Revision 1
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101772630 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101772630