Harmonization international

The quality of a drug substance is controlled by its specification. An internationally harmonized guideline on specifications and tests for chemical substances as active ingredients and in drug products makes reference to chiral compounds. This has recently been finalized and is discussed in Section 13.5.2. 

Some internationally harmonized guidelines regarding specifications and tests, impurities and validation of analytical methods have particular relevance to the development of chiral drugs and are discussed below. In addition, the impact of work on the common technical document is considered. 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

Thompson M, Wood R (1993) International harmonized protocol for proficiency testing of (chemical) analytical laboratories. J of AOAC Intern 76 926-937. 

When MRLs are set under Japanese law, the Japanese authorities will consider the Codex MRLs for international harmonization. However, Japan has set original food consumption amounts and GAPs. In this respect, the Japanese regulatory agency retains the rights to establish original values for the MRLs for each commodity based on toxicological exposure assessment. 

The benefits associated with an international harmonization approach include increased predictability and consistency of review time - a benefit to both industry and government. Also, harmonization of common formats allows evaluators to focus on the science of the reviews where less time is spent looking for information or reformatting information. With the use of electronic tools, evaluators can re-use information through copy and paste techniques. 

EDS has an important role in the international harmonization of pesticide registrations in facilitating the shared reviews among countries. Since multiple countries will be involved, this presents an expanded aspect to the issue of EDS systems compatibility. 

In recent years, regulatory authorities and industry associations have undertaken several important initiatives to promote international harmonization of regulatory requirements. These efforts are designed to enhance harmonization and are committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. These efforts are undertaken under the auspices of the International Conference on Harmonization (ICH), which is organized to provide an opportunity for tripartite... 

IUPAC (1993) Analytical Chemistry Division, Commission on General Aspects of Analytical Chemistry The International Harmonized Protocol for the Proficience Testing of (Chemical) Analytical Laboratories. Pure Appl Chem 65 2123... 

Lubiniecki, A. 1997. Potential influence of international harmonization of pharmaceutical regulations on biop-harmaceutical development. Current Opinion in Biotechnology 8(3), 350-356. 

Koeter, H. International harmonization of immunotoxicity testing. Human Experimental Toxicology, 14(1), 151-154, 1995. 

Fujimori, K. (1999). The role of general pharmacological studies and pharmacokinetics in the evolution of drugs (1) The role of general/safety pharmacology studies in the development of pharmaceuticals International harmonization guidelines. Folia Pharmacologica Japo-... 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

Support to European and international harmonization activities of the CPMP and its working parties. 

One of the earliest references to USP s commitment to international harmonization may be found in the historical introduction to the 3rd revision [1] of the U.S. Pharmacopeia (1851) The new Dublin and London Pharmacopoeias were compared with our own, with a view of introducing uniformity wherever more important considerations did not seem to forbid the requisite modifications.. .. Note that uniformity for its own sake was not the sine qua non. 

Joint Pharmacopeial Open Conference on International Harmonization of Excipient Standards Orlando, FL January-February 1991... 

International Harmonization of General Monographs on Dosage Forms and Pharmaco-technological Test Methods Seville October 1998... 

Pharmaceutical Manufacturing Association of Tokyo and Osaka, Conference on International Harmonization of Pharmaceutical Quality-Vision of Pharmacopoeia in the 21st Century, PMA, Tokyo, 1990. 

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