Disregard any peak with an area less than 0. Int J Clin Pharmacol Ther. Durand-Stamatiadis, Director, Information and Communication, World Self-Medication Industry, Ferney-Voltaire, France; Dr P. Training workshops had been organized in India, Malaysia and Ukraine for countries in the regions. .
Quality control — specifications and tests 3. Poompanich, Division of Drug Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Dr H. Although in some cases pharmacodynamic equivalence studies can be an appropriate tool for establishing equivalence, in others this type of study cannot be performed because of a lack of meaningful pharmacodynamic parameters that can be measured; a comparative clinical trial then has to be performed to demonstrate equivalence between two formulations. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. Chali, Chemical and Pharmaceutical Assessor, Uppsala, Sweden; Mr X. Moser, Galenica, Berne, Switzerland; Dr A. If safe delivery is possible by means of airmail, this ought to be the preferred method as it is much less expensive for all parties.
Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. Sheth, Vice-President, International Pharmaceutical Federation, New Delhi, India; Ms R. All 16 supplements are written in a standard format and each contains a reference section with hyperlinks to relevant supporting materials, most of them available free online. Bensouda, Mohammed V University, Laboratory of Galenical Pharmacy, Rabat, Morocco; Dr D. Surfactants should not be used in the dissolution media.
These guidelines do not cover requirements for manufacturing sites for the production of sterile pharmaceutical products. The Expert Committee adopted the monograph subject to the amendments agreed. The methodology for establishing equivalence between pharmaceutical products by means of a clinical trial with a therapeutic end-point conducted in patients is not yet as far advanced as that for bioequivalence studies. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. Data should be collected and reviewed against predetermined acceptance criteria and fully documented in process validation reports. A meeting of ethicists was convened at which it was unanimously agreed that it was right to use these medicines in this situation.
Minor corrections were recommended and incorporated. The following new guidelines were adopted and recommended for use. Prequalification of quality control laboratories 11. As a rule, campaign work in their processing is necessary. Brown, Inspections Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency, London, England; Dr W. They are not intended to be prescriptive in specifying requirements and design parameters.
The results should meet the acceptance criteria; deviations and out-of-limit results should be investigated. Nomenclature, terminology and databases 13. Normally, intermediate and bulk products should not be stored beyond the established hold time. The Expert Committee noted the report. Journal of Chromatography A, 2009, 1216:8918—8925. Mazurek, Drug Institute, Warsaw, Poland; Dr A.
Muhairwe, Executive Secretary and Registrar, National Drug Authority, Kampala, Uganda; Dr. Responsibilities of the members of the research team 23. Good Manufacturing Practices: supplementary guidelines for the manufacture of herbal medicinal products. Loss on drying, or water content. When such equipment is used, it is advisable that it does not come into direct contact with chemicals or contaminated material. Good manufacturing practices for pharmaceutical products. Singh, Drugs Controller General, Ministry of Health and Family Welfare, Government of India, New Delhi, India.
Agoumi, Medicines and Pharmacy, Ministry of Health, Rabat-Institute, Rabat, Morocco; Mrs S. The progress already made was noted. Surfactants should not be used in the dissolution media. Results showed 155 compliant products, 47 noncompliant ones and one that could not be evaluated. Tests and specifications for artemisinin starting material C15H22O5 Relative molecular mass: 282.