// March 07, 2022

Bolstering capabilities to support the supply of quality medicines

Strengthening the medicine supply chain

Empty store shelves and media headlines have raised public awareness of the complexities, interdependencies, and fragility of the global supply chain. The lack of access to everyday items has been a source of frustration for many. But in the case of medicines, disruptions to the supply chain are more than an inconvenience, as they can cost lives.

Strengthening the medicine supply chain is a global imperative and one to which USP has long been committed. Our efforts to help strengthen the medicine supply chain aligns directly with our mission to advance the supply of quality-assured medicines to improve the health and wellbeing of people around the world.

We recognize that strengthening an increasingly complex global medicine supply chain requires a multi-faceted approach, where multiple stakeholders, including USP, have a role to play. Though USP is best known for its standard setting activities, we have long engaged in advocacy and capability building activities that compliment and amplify our mission.

In advocacy, USP works in the U.S. and around the world to raise awareness of the impact of quality, elevating the use of public quality standards as critical tools to advance worldwide progress on health priorities. Harnessing a broad coalition of diverse stakeholders, we use our collective voices to help inform effective policymaking and help build a stronger public health safety net.

As an institution, USP has a long history of capability building, helping develop competencies and skills that advance access to quality-assured medicines around the world. From education opportunities that develop individuals’ technical competencies, to programs for verifying quality on an organizational level, to support for stronger healthcare system infrastructures, we continue to expand our capability building work to strengthen individual and organizational capacity to address local, regional, and global health issues.

Building foundations for quality-assured medicines

USP’s science-based standards have long supported the development, manufacture, distribution, and administration of medicines and other health products in over 150 countries. Many of these standards provide specifications, limits, and testing methods to determine the identity of a drug, control for harmful levels of impurities, and ensure the correct potency of the drug and its ability to be properly absorbed in the body.

Performance of these analytical testing methods requires trained laboratory personnel with the requisite technical knowledge and expertise. The true value of USP standards is realized when coupled with capability building, provided, in part, through USP’s Education portfolio. On-demand and live courses, webinars, and workshops help technical staff develop the understanding and skills needed for the proper interpretation and applications of USP standards.

Evaluating quality in the upstream supply chain

Among the many challenges faced by drug manufacturers is the procurement of quality-assured drug ingredients. This problem becomes acute when supplies from established sources are disrupted. Manufacturers are forced to find new suppliers with quality and reliability they can trust.

Verification by a trusted, independent third party is one way for manufacturers to evaluate prospective suppliers. USP’s Verification Programs for dietary supplements, excipients, and active pharmaceutical ingredients (APIs) use multi-step, evidence-based processes to confirm that a supplier has the appropriate quality systems in place and procedures are consistently being followed.

If, in the process of auditing, deficiencies are detected, the USP Verification Program recommends remediation actions and works hand in hand with the manufacturer in their journey to attaining the coveted USP Mark.

For manufacturers, USP Verification confirms that a supplier has sufficient controls in place to ensure product quality. This supports their ability to identify reputable sources of drug ingredients and reduces the risk of future quality issues for their products. For suppliers, USP Verification shows their customers that their products conform to identity and quality specifications, potentially making them more competitive in a global marketplace.

Strengthening medicine quality assurance globally

With funding from donors including the Global Fund, World Bank, and United States Agency for International Development (USAID), USP Global Health and Manufacturing Services programs strengthen medicines quality assurance systems, increase the supply of quality-assured medicines, and develop capacity to detect and remove poor-quality medicines from the market.

For more than 25 years, USP has helped support manufacturers and regulators around the world towards reaching international standards, including supporting over 40 World Health Organization (WHO) pre-qualifications for essential medicines. We have worked with regulators and manufactures in more than 40 countries to advance towards international best practices and standards. USP’s USAID-funded Promotion the Quality of Medicines (PQM) and PQM+ programs have strengthened manufacturers’ systems, processes, and resources for quality assurance/control, risk management, and good manufacturing practices (GMP) compliance. Training on topics related to quality assurance and GMPs increases the scientific/technical expertise of manufacturers to produce quality-assured essential medicine and helps local regulators improve and sustain local health systems.

Holistic approaches to addressing manufacturing challenges

Through our international donor-funded work, USP learned about the huge impact direct technical assistance to manufacturers can have on medicines quality. We also recognized that manufacturers’ needs went beyond our donor funded programs. They are looking for a trusted organization like USP to support them on their quality journey. We have continued to explore new ways to work with manufacturers towards our common goal of strengthening the global supply of quality assured medicines. The recent acquisition of Pharmatech Associates, Inc. expands USP’s ability to support individual manufacturers with consulting services to enhance their capacity to bring quality medicines to patients.

Pharmatech Associates will remain a separate entity from USP. Pharmatech Associates is a global consultancy for the life science industry that specializes in product and process development, quality compliance, and regulatory affairs. For over 25 years, Pharmatech Associates has helped manufacturers in the regulated life sciences, pharmaceutical, and medical devices industries satisfy regulatory requirements, scale up manufacturing, effectively manage quality control, and remediate quality problems.

With pragmatic solutions tailored to a company’s needs, Pharmatech Associates is helping address some of the most challenging and novel areas, including continuous manufacturing, mRNA, and cell and gene therapies. Insights from scientists with leading-edge expertise in biologics and advanced therapeutics gives USP a deeper understanding of the challenges faced during the drug development lifecycle. We hope to translate these insights into scientific knowledge and standards that better enable innovation and meet the needs of our stakeholders.

Building manufacturing capabilities to optimize impact

Increased awareness of supply chain vulnerabilities and countries looking to strengthen their domestic pharmaceutical production has opened a window of opportunity to maximize the impact of USP standards, advocacy, and capability building programs. Looking ahead, we will continue to expand our work to support quality along the continuum of the medicine supply chain. Our capability building work will help ensure that manufacturers and regulators around the world have access to tools and technologies they need to strengthen quality systems in their own countries. Only when these resources and innovations have been democratized and made available to manufacturers and regulators around the world will patients realize the full benefit, in the form of greater access to quality assured medicines. Our close work with these and other stakeholders will help us better understand their needs so we can develop future solutions that meet medicine quality challenges.