Compendial Globalization: Achieving Harmonization through Standardized Practices and Collaboration - Pharmaceutical Technology

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Compendial Globalization: Achieving Harmonization through Standardized Practices and Collaboration
The authors discuss a new approach to address globally harmonized compendial standards.

Pharmaceutical Technology
Volume 36, Issue 4, pp. 94-101

Compendial globalization

The approach presented here builds upon the success of retrospective and prospective harmonization, along with recent bilateral partnerships among the pharmacopeias, to serve the needs of patients in both developed and emerging markets. The goal of this approach is to provide harmonized, globally applicable quality standards for medicines within the existing framework of multiple national and regional pharmacopeias to the benefit of patients worldwide.

Figure 1: The three principles of compendial globalization. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
Compendial globalization provides a basis for the pharmacopeias to work together in new ways with consistent processes coupled with sharing of information and work. The concept is illustrated in Figure 1, which depicts a 3-legged stool to emphasize the balance needed among the 3 principles. The stool is set upon the foundation of "Patient Benefit," accomplished through the global availability of medicines with consistent and appropriate quality requirements. The specific objective is depicted by the seat of the stool: the development of globally harmonized compendial standards. Supporting the stool are the 3 legs or principles of compendial globalization:

1. Standardized pharmacopeial practices, which set forth consistent and agreed upon philosophy, structure, principles, and practices (both technical and quality) for use by pharmacopeias in the elaboration of compendial standards (monographs and general chapters).

2. Pharmacopeial collaboration, which enhances co-operation among the pharmacopeias to enable development, sharing, and adoption of new and revised harmonized compendial standards.

3. Regulatory acceptance, which ensures participation of and agreement by regulatory authorities with the harmonized processes and outcomes in those countries where the standards apply.

Standardized pharmacopeial practices

Table I: Considerations for standardized pharmacopeial practices.
The first principle of compendial globalization is the establishment of a consistent set of acceptable practices to be used by individual pharmacopeias in the elaboration of new and revised compendial standards (see Table I). Having a common philosophy, structure, principles, and practices (both technical and quality) that are agreed upon by the pharmacopeias and impacted stakeholders will ensure the development of appropriate compendial standards for pharmaceutical ingredients and dosage forms. Standardized practices would provide compendial standards that could be harmonized and made globally applicable to ensure appropriate quality for medicines used by patients worldwide. Additionally, regulatory agencies will have assurance that compendial standards are interchangeable because they would be developed using the standardized pharmacopeial practices. It is worth noting that global standards have been achieved and broadly accepted in other industries (e.g., aviation and communication) through the efforts of international and national standards-setting organizations.

Many of the individual components that would make up the standardized practices may already be in place for individual pharmacopeias, but have not been considered with a view towards consistent and comprehensive application across all of the pharmacopeias. The key impacted stakeholders (pharmacopeias, regulators, and industry) must collaborate to bring these components together and establish the details of the standardized practices. Collaboration between the pharmacopeias to establish the standardized practices can be extended to the development of harmonized compendial requirements.

Pharmacopeial collaboration

Table II: Considerations for pharmacopeial collaboration.
The second principle of compendial globalization is pharmacopeial collaboration (see Table II). This principle builds upon the standardized pharmacopeial practices, so that compendial standards developed by one pharmacopeia may then be adopted by other pharmacopeias to provide globally harmonized standards. Pharmacopeial collaboration will enable the coordination and sharing of information and best practices among pharmacopeias with improved effectiveness and efficiency in resource utilization for the pharmacopeias and other impacted stakeholders. As a practical beneficiary of the harmonized outcomes, the pharmaceutical industry plays an important role in this collaboration by facilitating the exchange of information during the development of compendial standards.

Pharmacopeial collaboration should draw from other approaches to pharmaceutical globalization, such as the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which provides opportunities for sharing of resources and information among regulatory agencies. Pharmacopeial collaboration can build upon existing partnerships and establish new processes to include development, implementation, maintenance, and sharing of compendial standards. The underlying basis for successful pharmacopeial collaboration is the development and consistent application of standardized practices by the pharmacopeias, as previously discussed. The key to success is the regulatory acceptance of the work performed via these standardized practices and collaboration.


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