What is USP
There are many standards in the medical field, and these standards are crucial in controlling the quality of care. For instance, certification, licensing, and accreditation programs are frequently used by health care organizations to control the services and performance of providers. These kinds of initiatives are becoming more and more widespread. A health care organization can publicly declare that it has met national or international health care quality standards by receiving recognition from these programs, which ideally measure organizational performance against verified, evidence-based standards.
The United States Pharmacopeial Convention (USP) is a nongovernmental standards-setting organization that develops documentary and physical standards for chemical drugs, excipients, and biologics in the US and abroad, in contrast to organizations that concentrate on creating and upholding professional standards.
History:
The first United States Pharmacopeia (USP) was published in 1820 by a group of medical professionals who were worried about the consistency and quality of medications. It included recipes for 217 medications that were deemed to be the “most fully established and best understood” at the time. The National Formulary (NF), established in 1888 by the American Pharmaceutical Association, contained unofficial preparations and formulations for commonly sold products.
However, standards in the USP and NF were not given a role in determining whether drugs would be considered “adulterated” under federal law until the Federal Food and Drugs Act was passed in 1906. A few decades later, the Federal Food, Drug, and Cosmetic Act of 1938 added nonproprietary naming and a definition of misbranding (i.e., packaging and labeling that does not comply with USP and NF guidelines) to the list of applicable USP and NF standards. When USP finally acquired the NF in 1975, the two publications were combined under a single cover to form the United States Pharmacopeia–National Formulary (USP–NF).
Through the yearly release of The National Formulary (USP-NF) and the United States Pharmacopeia, the USP establishes and upholds quality standards. U.S. law recognizes USP standards that control the identity, strength, quality, purity, and the packaging and labeling of pharmaceuticals. The USP Council of Experts and other committees and panels comprise the volunteer experts in the field who develop and approve USP standards.
Over 5000 quality standards for pharmaceuticals (chemical and biologic); excipients (inactive ingredients); and active pharmaceutical ingredients (APIs) are included in the United States Pharmacopeia – National Formulary (USP-NF). It is the world’s most comprehensive source of information on pharmaceutical quality standards. The USP-NF standards are used to safeguard patient safety and help assure the quality of medications and their ingredients.
Furthermore, USP is applied in more than 140 nations and incorporated into the legal framework of more than 40 nations.
Publishing Schedule:
Over time, the USP’s publication schedule also underwent modifications. The USP was published every ten years from 1820 to 1942, every five years from 1942 to 2000, and every year starting in 2002.
Governance:
The USP Convention membership, the Board of Trustees, and the Council of Experts and its Expert Committees are the three bodies that oversee the organization. All of the members are volunteers from all over the world.
USP Convention Membership
USP has consistently prioritized an independent and collaborative approach to its work, as evidenced by the thousands of expert volunteers who have volunteered their time to develop USP standards and the nearly 450 Convention Member Organizations who have committed to helping shape USP’s areas of focus.
In order to achieve this, the Convention Membership encompasses viewpoints, experiences, and knowledge from various healthcare and scientific fields, as well as from across the world.
Board of Trustees
The work of USP is vital, intricate, and changing quickly. The Board of Trustees, which oversees the sustainability of USP, is made up of reputable professionals and seasoned leaders. Together, they offer direction and supervision that support the maintenance and growth of USP’s influence on public health.
Council of Experts and its Expert Committees
In order to maintain a more reliable supply of high-quality medications, USP standards are crucial. Each member of the Council of Experts chairs a USP Expert Committee, which is responsible for monitoring the organization’s scientific and standard-setting decisions. These international leaders give their time, knowledge, and enthusiasm to support USP’s mission.
Ingredient Verification Program for Active Pharmaceutical Ingredients
Erroneous evaluation of quality risks may result in product recalls, legal action, and even harm to patients. Through its demonstration of compliance with current Good Manufacturing Practices (cGMPs) and product quality standards, USP’s Ingredient Verification Program for Active Pharmaceutical Ingredients (APIs) aids in ensuring the quality of APIs.
This entails adhering to industry best practices and regulatory requirements for APIs, such as ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Additionally, this extensive program lowers inspection expenses, helps qualify suppliers, and lessens the possibility of inconsistent or subpar-quality ingredients.
USP’s Ingredient Verification Program for APIs helps ensure the quality of APIs by:
- Auditing manufacturing sites for conformance with cGMPs
- Reviewing quality control and manufacturing (QCM) product documentation
- Testing product samples in laboratories
- Monitoring annually with cGMP audits, QCM documentation reports and product testing (https://www.usp.org/verification-services/api-verification-program)
Designation of an Active Pharmaceutical Ingredient (API) as USP grade
Following the guidelines provided in the United States Pharmacopeia (USP) is usually what determines whether an Active Pharmaceutical Ingredient (API) is USP grade. This consists of a list of requirements for the identity, potency, caliber, and purity of medications, excipients, and APIs. By adhering to these guidelines, the API is guaranteed to be of the caliber needed for pharmaceutical use in the US.
USP Certification
As a global non-profit organization, USP assists producers in guaranteeing the caliber of their goods by inspecting and testing each one as part of the USP verification program. Three distinct aspects of production are examined in this yearly evaluation: manufacturing processes and product quality control, facility audits, and product testing. A product that has received USP certification indicates that it:
- Contains the ingredients listed on the label, in the declared potency and amount
- Does not contain harmful levels of specified contaminants
- Will break down and release into the body within specified amount of time
- Has been made using safe, sanitary, and well-controlled manufacturing practices according to FDA and USP guidelines
Why Do These Certifications Matter?
Not every product that is sold online or on store shelves is of the same quality. People can confirm that what they’re consuming is indeed what they believe to be taking by using third-party testing conducted by institutions such as USP. Businesses that hold USP certification have also paid these organizations to evaluate their products. (https://eyepromise.com/eyepromise-blog/usp-vs-nsf-certification/)
EP, USP and JP
Three of the most common pharmacopoeia editions are the European Pharmacopoeia (EP), The United States Pharmacopoeia (USP), and Japanese Pharmacopoeia (JP). Many countries have their own pharmacopoeia to insure the quality of health products sold in their country.
The three significant companies responsible for these pharmacopoeias are:
- The European Directorate for the Quality of Medicines (EDQM) – responsible for the European Pharmacopoeia (EP)
- The United States Pharmacopoeia Convention – responsible for the United States Pharmacopoeia (USP).
- The Pharmaceuticals and Medical Device Agency along with the Japanese Ministry of Health – responsible for the Japanese Pharmacopoeia (JP).
While these pharmacopoeias share many similarities, there are also some differences between them, such as the number of monographs, focus, and enforcement (Befir & Farlien 2023).
Pharmacopeial Harmonization
Harmonizing monographs and general chapters with the European Pharmacopoeia and Japanese Pharmacopoeia is a crucial USP endeavor.
The USP, EP, and JP collectively operate under the Pharmacopeial Discussion Group (PDG), which was established in 1989, to identify potential monograph or general chapter candidates for harmonization. In October 2023 the Indian Pharmacopoeia Commission joined the PDG as a pilot participant. As an observer, the World Health Organization attends PDG meetings. With an emphasis on compendial issues, the PDG collaborates in “harmony” with the International Conference on Harmonization (ICH). The PDG procedure and the current metrics for the harmonization of excipients and general chapters are explained in detail in the USP general information chapter 1196 Pharmacopeial Harmonization. Benefits of harmonization include the requirement for a single compendial standard for testing and the worldwide use of an article. The USP/EP/JP can have “identical” monographs or general chapters. Alternatively, the degree of harmonization can specify which attributes are harmonized and which are not in the published text (Cohen, 2008).
Acceptability of Standards from Alternative Compendia (BP/EP/JP)
The FDA has released an updated Manual of Policy and Procedure (MaPP), 5310.7, which, finally answers one of the long-standing queries: is it permissible to use a foreign compendia as the foundation for a specification or test method in an application? The response is a big “yes!” if the procedure meets or exceeds the USP/NF guidelines in a monograph or the general chapters.
The MaPP goes on to explain:
- The applicant must provide justification for using a standard from the BP, EP, or JP in the application rather than the USP/NF standard. Along with a statement acknowledging the corresponding USP/NF monograph as the official standard or the corresponding analytical procedure as the regulatory analytical procedure, the applicant should also submit a copy of the cited BP, EP, or JP monograph or analytical procedure.
- The proposed specification should be evaluated by the Office of Pharmaceutical Quality product quality reviewer to see if it can be deemed better to or equal to the relevant USP/NF standard.
- The respective Office of Pharmaceutical Quality Branch Chief and Division Director are responsible for the appropriate application of this MAPP (MAPP 5310.7 Rev. 1 2017).
Does Canada or Britain accept USP
Indeed, the United States Pharmacopeia (USP) standards are recognized and accepted by the regulatory frameworks of both Canada and the United Kingdom (Britain). While the safety, effectiveness, and quality of medications and healthcare products are the responsibility of national regulatory bodies, these organizations frequently consult international pharmacopeias, such as the USP.
In Canada, Health Canada is the regulatory authority responsible for overseeing the safety and effectiveness of health products, including pharmaceuticals. Health Canada may reference the USP standards as part of its evaluation and regulatory processes.
Medicines and healthcare products are regulated in a similar way in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA). While international standards, such as those from the USP, may also be taken into consideration, the British Pharmacopoeia (BP) is the one that is most frequently cited in the UK.
According to the Regulatory Affairs Professionals Society (RAPS), the United States Pharmacopeia (USP) and its British Pharmacopoeia (BP) have formalized their partnership to enhance medicine quality standards by executing a memorandum of understanding.
“Modern innovations make this partnership essential to ensuring the quality of medicines. Our partnership helps both organizations develop standards that are used to protect the quality of the medicines patients worldwide take each and every day,” said Jaap Venema, USP Chief Science Officer.
A collaborative effort between the two pharmacopoeias resulted in the first two harmonized monographs for finished drug products being announced by USP and BP in 2012.
James Pound, group manager for BP & laboratory services at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), commented:
“The work we do will directly benefit from the knowledge sharing and collaboration that will result from this agreement. This will better enable us to serve the needs of our patients and stakeholders across the world and address the future challenges of assuring medicines quality.”
REFERENCES:
- Cohen, E. M. (2008). The influence of the USP on the drug approval process. In The Pharmaceutical Regulatory Process (pp. 355-368): CRC Press.
- Heyward, J., Padula, W., Tierce, J. C., & Alexander, G. C. J. J. o. p. s. (2018). The value of US pharmacopeial standards: a review of the literature. Journal of pharmaceutical sciences, 107(10), 2611-2617.
- Williams, R. L., Team, P., Staff, U. J. J. o. p., & analysis, b. (2006). Official USP Reference Standards: Metrology concepts, overview, and scientific issues and opportunities. Journal of pharmaceutical and biomedical analysis, 40(1), 3-15.
- 4. Anderson L, Higby GJ. The spirit of voluntarism, a legacy of commitment and contribution, The United States Pharmacopeia 1820–1995, United States Pharmacopeial Convention, 1995:71, 6. www.ippsr.msu.edu/documents/forums/2006 may perlstadt history of fda.pdf.
- General Notices and Requirements and General Chapters. USP 2008, 2008:1–31 and 33– 374.
- Befir, Farlien. “Comparing International Pharmacopoeias: Similarities and Differences.” Pharmacoeconomics 8 (2023): 169.).