35th Anniversary Special: The Transformation of Regulation and Global Standards - Pharmaceutical Technology

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35th Anniversary Special: The Transformation of Regulation and Global Standards
How FDA, USP, and ICH have redirected industry practice.


Pharmaceutical Technology
Volume 36, Issue 7, pp. 45-49

The United States Pharmacopeia (USP)

The US Pharmacopiea (USP) was established in 1820 and is the oldest continuously revised compendia in the world. The standards and information published by USP are recognized as the legal standards by FDA and by regulatory authorities in other countries that have voluntarily adopted them. This compendium contains monographs for excipients, APIs, drug products, biologics, biotechnology products, general test procedures, and general information all of which govern the strength, quality, purity, and potency of medicinal products marketed in the US.

Monograph harmonization (1989). USP has a history of impactful events but none have been more significant than its efforts to harmonize monographs with its counterparts, the European and Japanese Pharmacopoeias (Ph. Eur. and JP, respectively). The harmonization process began in 1989, when representatives of the three pharmacopeias met with industry representatives in an open forum to discuss the need to harmonize like procedures to reduce the regulatory burden on pharmaceutical companies. Prior to harmonization efforts, companies were required to meet the specifications in the governing pharmacopeia for the region of the world where they wanted to market their product. To accomplish this goal, the three pharmacpeias established the Pharmacopeial Discussion Group (PDG) and developed a 7-step process for unifying monograph requirements. Under this model, more than 100 items have been harmonized. The efforts to harmonize monographs continue today.

Stakeholder forum (1999). USP introduced stakeholder forums in 1999, and the events became an officially recognized component of the USP family by vote at the 2005 USP Convention. Stakeholder forums allow for a free interchange of ideas between USP and industry trade organizations. The Prescription/NonPrescription Stakeholder Forum is the most active bi-annual meeting with USP. Among the participating organizations are IPEC, PDA, the Midwestern Compendial Discussion Group, and the Western Compendial Discussion Group. Through PDG, several USP initiatives have been implemented across the industry with little or no disruption to compliance. An example is the collaboration to implement the residual solvents standard, which took effect in 2008.

Flexible monographs (2004). The pharmaceutical industry has long recognized there is more than one way to synthesize an API and that the impurity profile for the ingredient is dictated by the specific route chosen. To accommodate impurity profiles based on the route of synthesis, USP started adopting multiple impurity methods to ensure all manufacturers of an API or the subsequent dosage form are able to reference the USP standard. These are identified and "Method 1," "Method 2," and so forth in the monograph. This practice has provided pharmaceutical manufacturers flexibility and sourcing alternatives for their products.

Globalization efforts (2011–2012). During the past decade, USP has changed its mission statement to indicate that it wishes to "improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods." Its current vision is "...to be a leader in promoting the public health by creating a unique knowledge base—consisting of quality standards and information on proper use—for medicines and related products and practices. USP will ensure that people throughout the world have access to this knowledge base." USP has opened offices in Switzerland, India, China, and Brazil. In addition, at the USP 2010 Convention, the organization passed Resolution 4, which deals with supporting and advancing global public-health initiatives. USP is also expanding its role in India and China and exploring relationships with the Association of Southeast Nations and Middle East and North African nations.


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