Harmonization drug quality standards

Modern Forums for Harmonization of Drug Quality Standards... 

MoUer, H. Oeser, W.H. Drug master files, global harmonization of quality standards, wissenschaftlich verlagsge-sellschaft MbH Stuttgart. 1992 213. 

MODERN FORUMS FOR HARMONIZATION OF DRUG QUALITY STANDARDS... 

It is clear today that the issue discussed above should be taken into account by pharmacopoeial committees and regulatory bodies involved in drug quality assurance for harmonization of requirements to analytical results and improvement of their quality, first of all while developing the reference standards. 

It is undoubtedly impossible to achieve harmonization of quality for new drugs without harmonization of compendial standards and methodology. The PDG will continue to proceed with what it believes to be the correct approach to pharmacopeial harmonization and to contribute to advancing effective harmonization for the quality of new drugs and products. 

In this manner, key objectives of harmonization will be attained only when the PDG is able to achieve mutually agreeable standards and test methods, which provide the same conclusions when performed on the same specimens, even if they use different specifications, procedures, or reagents. We should continue to take necessary steps to deepen international cooperation and to obtain harmonized compendial standards and methodology, using the PDG as the forum for harmonization of drug quality. 

Recent initiatives by global organizations such as ISO (International Organization for Standardization, www.iso.org) and ICH (International Conference on Harmonization, www.ich.org) are attempting to bring consistency in concept and standardization in definition to the QMS. In 2004, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S, www.picscheme.org) issued its recommendation on Quality System Requirements for Pharmaceutical Inspectorates. The U.S. Food and Drug Administration (FDA) initiated inspection surveillance approaches based upon QMS organization and is another source of definition and interpretation. 

The USP and NF standards of strength, quality, purity, and packaging and labeling are recognized by the U.S. Federal Food, Drug, and Cosmetic Act and Amendments since 1906. These requirements are enforced by the Food and Drug Administration (FDA), a party in the harmonization of requirements for drugs. 

The Japanese Pharmacopoeia (JP). The main and oldest document specifying standards for drugs is the Japanese Pharmacopoeia, first published in 1886. The JP is established by law (Article 41). It aims at regulating quality for important drugs used in healthcare and specific standard test methods. The JP is revised by law every 10 years, but in practice the revision is carried out every 5 years. The Thirteenth Edition was published in 1996 and already contains some monographs harmonized with the US and European Pharmacopoeias. 

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