Quality standards for efficiency in drug development and manufacturing | Quality Matters | U.S. Pharmacopeia Blog
 // June 30, 2020

Quality standards for efficiency in drug development and manufacturing

Contributors:

During the COVID-19 pandemic, we have become acutely aware of how precious time is and the potential repercussions of delays or inefficiencies. The healthcare and pharmaceutical industries along with governments and regulatory bodies around the world, have responded with an unprecedented sense of urgency to develop therapeutics that treat and prevent SARS-COV-2 infection.

The development of treatments in response to this urgent need cannot come at the expense of quality. A recent review, published in the Journal of Pharmaceutical Sciences, discusses the value of quality standards in the pharmaceutical industry and how established and accepted standards are fundamental to broad availability of quality medicines and support efficiency of drug development and manufacturing.

Efficiency in the age of globalized medicine

The complexity and globalization of the pharmaceutical supply chain necessitate that standards are built into development and manufacturing processes – from raw materials through finished products.  Standards are essential to ensuring the identity, purity, potency and performance of drugs across the product lifecycle.

Standards can speed up the process of getting drugs to market. In a 2018 survey, 90% of industry professionals with expertise formulating and testing drugs, indicated that standards accelerated drug development, especially in the case of generics, saving about 19% in total product development time.1

There is inherent efficiency in establishing accepted norms and definitions for quality: once developed, a standard can be shared and used widely, conveying quality benefits to multiple parties. The time and resources that drug developers otherwise would need to develop their own standards can instead be reallocated to other, potentially more productive endeavors.  When standards are systematically collected into a compendium, they create a single, authoritative source that establishes a common understanding of the attributes, tests and acceptance criteria that define product quality.

Articulating expectations for quality

In the United States, the Food and Drug Administration (FDA) reviews the safety and effectiveness of drug products. When submitting drug products for regulatory approval, manufacturers that plan to market their products in the U.S. must provide data that demonstrates compliance with standards set by the U.S. Pharmacopeia (USP), as required by federal law. As an independent, scientific organization, USP has been setting standards for medicines for the past 200 years. USP documentary standards and reference materials are available to pharmaceutical developers, manufacturers and regulatory bodies. Using USP standards can help expedite timelines by eliminating the need for manufacturers to independently develop standards, which would then need to be further validated, as well as increase regulatory predictability by articulating regulatory expectations for quality.

Shaping the future of quality standards

Medicinal products (gene therapy, personalized medicine, and other emerging therapeutic modalities) grow increasingly complex. Quality attributes of these products are also more complex, difficult to define and measure, making standards even more critical to ensuring quality. For standards to remain relevant, they must evolve in response to advances in the industry. Existing standards need to be updated, and new, fit-for-purpose standards created to ensure they include the most useful, appropriate, and feasible approaches to measuring relevant parameters.

Standards setting organizations like USP don’t purport to have all the answers. In USP’s case, standards are developed and adopted through a public, science-based, and transparent process.2 Vetted through independent laboratory testing and subject to an open, public review process, the resulting standards are robust and data-driven, reflecting input from experts from around the world.

USP welcomes collaboration with independent scientists and other stakeholders from industry, academia, government, and health care practitioners. Opportunities to contribute to shaping the future of pharmaceutical standards include meetings with expert volunteers, workshops, volunteering to revise and develop standards and providing input and feedback on standards during public comment periods.

Only through the engagement and participation of those who stand to benefit from them will quality standards continue to ensure quality, increase efficiency and deliver value. Learn more about USP quality standards.

 

[1] Warthin IK, Berik J, Podolsky D, Raghavendran V, Reddy R, Chang J, Porter N, Garito N 2020. Commentary on the Benefits of US Pharmacopeial Standards: A Generic Pharmaceutical Industry Survey. J Pharm Sci 109(2):944-949.

[2] USP. 2006. Rules and Procedures of the 2005-2010 Council of Experts. USP29-NF 24, ed., Rockville, MD: United States Pharmacopeial Convention. p 3476.