Last Updated on July 13, 2023 by The Health Master
Testing of Excipients
The United States Pharmacopoeia (USP) has taken proactive measures by establishing a dedicated program unit team focused on excipients.
With a mandate for fiscal 2024, this initiative will primarily concentrate on di-ethylene glycol (DEG) and ethylene glycol (EG), aiming to improve the testing of excipients and enhance the criticality of testing methods through collaborations with the USP headquarters.
Rising Concerns Prompt Action:
The Central Drugs Standard Control Organization (CDSCO) office recently conducted extensive risk-based inspections throughout India in response to a significant development.
Importance of Testing Excipients:
Girish Kapur, Vice President (VP) of India Site Operations and Site Head at USP, emphasized the criticality of testing excipients due to their direct correlation with patient safety.
Traditionally, excipient testing focused on the end-use in the drug product. However, this approach has evolved over the years.
The current best practice is to incorporate excipient testing throughout the formulation process, adhering to the principles of Quality by Design (QbD).
Excipients play a vital functional role in drug products, making it essential to counter and mitigate potential risks.
Dedicated Expert Committees and Resources:
Recognizing the evolving landscape, USP has established dedicated expert committees focusing on excipient characterization, variability, performance, and composition.
These committees are supported by several general chapters that provide comprehensive guidance on testing different excipients in laboratories.
Additionally, the National Formulary (NF) contains over 500 excipient monographs, with more than 60% of them having physical reference standards.
This wealth of resources enables thorough evaluation and standardization of excipients.
The Impact of COVID-19 on the Excipient Supply Chain:
The COVID-19 pandemic has underscored the importance of a resilient supply chain. The excipient supply chain, already complex, faces further challenges with the emergence of complex generics in the pharmaceutical industry.
Novel excipients, beyond the traditional ones like starch, CMC, and HPMC, introduce increased vulnerability to adulteration.
As excipients directly influence the quality of the drug product, maintaining integrity throughout the supply chain is crucial.
Integration and Standards:
USP maintains a strong integration with its counterparts in the United States, boasting a significant laboratory facility in Hyderabad, India.
As a standard-setting organization, USP emphasizes the importance of a robust public input system to gather feedback on monographs published in the USP and the NF.
The standards contained within USP-NF play a critical role in ensuring the quality of medicines and their ingredients, ultimately safeguarding patient safety.
USP is recognized as the official quality standard for medicines marketed in the United States.
Understanding Excipients’ Role:
Excipients account for approximately 90% of the dosage forms available in the market.
Their role in pharmaceutical products is vital, as they contribute various physical characteristics such as flowability, compressibility, disintegration, and controlled drug release.
Excipients also have the potential to influence organoleptic properties such as taste and texture, which are essential parameters for evaluating drugs sold in the market.
The establishment of the program unit team by the United States Pharmacopoeia underscores the growing importance of testing and ensuring the quality of excipients.
With a focus on di-ethylene glycol (DEG) and ethylene glycol (EG), this initiative aims to enhance testing methods and criticality.
By embracing Quality by Design (QbD) principles and leveraging the extensive resources available, USP is committed to promoting patient safety and maintaining the integrity of pharmaceutical products.
Disclaimer: This article contains information derived from Pharmabiz. Our team utilized an AI language model, to rewrite and present the news in a unique format.
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