The Ideal Pharmacopeia - Pharmaceutical Technology

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PharmTech Europe

The Ideal Pharmacopeia

Pharmaceutical Technology
Volume 32, Issue 11, pp. 122-125

Facilitate drug registration. The ideal pharmacopeia can simplify and facilitate the preparation and assessment of regulatory applications by providing common standards for generally accepted quality parameters for pharmaceuticals. By defining test methodology and acceptance criteria, the pharmacopeias ensure that standardized approaches may be used by all regulatory authorities and by industry. This permits regulators and manufacturers to focus on the evaluation of unique attributes of the drug substance or dosage form. The evaluation of many of these unique attributes can also be based upon the standardized test methods and criteria established in the pharmacopeia.

It is beneficial to be able to reference a particular excipient monograph or General Chapter to indicate the tests and methods used, and the quality standards that apply. Specific pharmacopeial monographs can streamline communication between manufacturers and regulators by providing a common understanding of suitable quality attributes for the ingredients. For example, reference to "Hypromellose USP, Ph. Eur., and JP" as an excipient in a solid oral dosage form enables a manufacturer to indicate to regulators the quality attributes based on the monograph standard for this excipient without the need for additional details on the tests, methods, or acceptance criteria.

Similarly, dosage-form monographs and General Chapters provide a common language around analytical methods that may be applied to products or ingredients. For example, indicating that a drug product complies with the pharmacopeial requirements for "uniformity of dosage units" facilitates preparation and review of a product registration, while still providing clear understanding of the applicable quality attribute for the product. References to pharmacopeial standards in drug product registrations provide a common understanding through succinct language, with clear and precise meaning. This mutual understanding facilitates interaction between pharmaceutical manufacturers and regulatory agencies, thereby bringing clarity and efficiency to the processes for regulatory review of drug applications and inspection of facilities.

Additional benefit to industry and regulators resulting from pharmacopeial standards can be derived through the compendial revision process. As monographs and General Chapters are updated to reflect improvements in materials, methods, and technology, reference to appropriate pharmacopeial requirements enables drug product registrations to stay up-to-date with current standards of quality, thereby providing enhanced public health protection.

Support regulatory agencies. Alignment between the pharmacopeias and regulators is essential. In practical terms, the ideal pharmacopeia should include standards that are consistent with the needs and expectations of regulatory authorities. Drug product availability may be jeopardized and costs may be increased without benefit if industry is compelled to meet conflicting pharmacopeial and regulatory requirements. The need for alignment emphasizes the extremely important supporting role that pharmacopeias play in today's regulatory drug product review and approval process. Differing expectations and requirements for a particular method or process, as may be created by general chapters in the pharmacopeia that are in conflict with guidelines from regulatory agencies, provide little more than a roadblock to drug review and compliance. Pharmacopeial standards are only meaningful in the context of an effective regulatory framework. An ideal pharmacopeia, therefore, should align with and support the laws, regulations, and guidelines of the relevant regulatory authorities.

A single, global compendial standard. The ideal pharmacopeia should provide a single compendial standard that can be used worldwide. While the goal of a single global standard may seem the most difficult to achieve, it is also the most critical. Today's global healthcare system operates across country and regional boundaries. A patient in the US may have a prescription filled from a pharmacy in Canada for a drug product that was manufactured in Europe. A global pharmacopeial standard can help ensure that patients anywhere in the world receive consistent quality medicines no matter where the products are manufactured or sold.


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