Download or read book The International Pharmacopoeia written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 1526 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.
Download or read book The International Pharmacopoeia Tests methods and general requirements quality specifications for pharmaceutical substances excipients and dosage forms written by World Health Organization and published by . This book was released on 1979 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The International Pharmacopoeia written by and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Pharmacopoeia [1] (Ph. Int.) comprises a collection of recommended procedures for analysis and specifications for the determination of "pharmaceutical substances" (active pharmaceutical ingredients), excipients and "dosage forms" (general texts and individual finished pharmaceutical products) that is intended to serve as source material for reference or adaptation by any World Health Organization (WHO) Member State wishing to establish pharmaceutical requirements. The pharmacopoeia, or any part of it, shall have legal status whenever a national or regional authority expressly introduces it into appropriate legislation. Further explanation of the role of The International Pharmacopoeia is provided in the section entitled "Scope and function" below. A summary of the history and major changes in the previous versions is provided in the folder "Background to previous editions of The International Pharmacopoeia"--The International Pharmacopoeia is based on advice and decisions from the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP). All specifications included in this Seventh Edition have been developed following the WHO consultation process and were adopted by the ECSPP
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting and published by World Health Organization. This book was released on 2016 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality, safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines, from their development to their distribution to patients. In the area of quality control, the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia, and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM), the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs, general texts and ICRS. It noted the report on Phase 6 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further acknowledged the progress of good pharmacopoeial practices (GPhP), and adopted the document on GPhP which was prepared by the consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP), distribution and trade of pharmaceuticals and regulatory practice. It adopted 10 guidelines as listed below as well as 22 new specifications and general texts for inclusion in The International Pharmacopoeia. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project.
Download or read book The International Pharmacopoeia Volume 3 Quality Specifications written by and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The International Pharmacopoeia Tests and general requirements for dosage forms written by and published by . This book was released on 1979 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting and published by World Health Organization. This book was released on 2015-05-11 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines from their development to their distribution to patients. In the area of quality control the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs general texts and ICRS. It noted the report on Phase 5 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further received a concept paper on the benefits of good pharmacopoeial practices (GPhP) and was informed of progress achieved with developing a comprehensive document on GPhP through discussions at consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP) distribution and trade of pharmaceuticals and regulatory practice. It adopted eight guidelines and 16 technical supplements as listed below including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project. The report includes the following annexes which are recommended as new WHO guidelines: . Annex 1. Procedure of the development of monographs for inclusion in The International Pharmacopoeia (revision); . Annex 2. Updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia (revision); . Annex 3. Supplementary guidelines on good manufacturing practices: validation; Appendix 7: non-sterile process validation (revision); . Annex 4. General guidance for inspectors on hold-time studies (new); . Annex 6. Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (revision); . Annex 7. Guidelines on registration requirements to establish interchangeability (revision); . Annex 8. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (revision); . Annex 9: Good review practices guidelines for regulatory authorities (new). In addition 16 technical supplements to the WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products were adopted for publication in a format which is appropriate to the large volume of this guidance (Annex 5). The newly adopted monographs were adopted for inclusion in The International Pharmacopoeia. Following the implementation of the revised general monograph on parenteral preparations the Committee adopted the proposed endotoxin limits for 11 parenteral dosage form monographs lacking such specification together with related updates to relevant monographs. The Committee adopted 12 ICRS newly characterized by the custodian centre EDQM. The Committee further adopted the workplan for new monographs to be included in The International Pharmacopoeia.
Download or read book The International Pharmacopoeia Volume 2 Quality Specifications written by and published by . This book was released on 1981 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book International Pharmacopoeia written by World Helth Oeganization and published by . This book was released on 2003 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations and published by World Health Organization. This book was released on 2014 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.
Download or read book The International Pharmacopoeia Quality specifications written by World Health Organization and published by . This book was released on 1979 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Students will sharpen their language arts and mathematical skills through robust, relevant, and real-world practice. Linked to specific Common Core State Standards, the activities are designed to help prepare students for bright educational futures. The quick and fun activities focus on concepts such as reading foundational skills, fluency, and measurement"--P. [4] of cover.
Download or read book International Pharmacopoeia V 3 Quality Specifications written by and published by . This book was released on 1988 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The International Pharmacopoeia Volume 4 Tests Methods and General Requirements Quality Specifications for Pharmaceutical Substances Excipients and Dosage Forms written by and published by . This book was released on 1994 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The International Pharmacopoeia written by World Health Organization and published by WHO. This book was released on 1979 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. Volume five of this publications describes methods and procedures for the quality control of pharmaceutical substances and tablets, tests for dosage forms for suppositories and opthalmic preparations, and a new section on quality control of anti-malarials. Supplementary information on International Chemical Reference Substances and International Reference Spectra, and on the establishment, maintenance and distribution of chemical reference substances are also included.
Download or read book Specifications for the Quality Control of Pharmaceutical Preparations written by and published by . This book was released on 1967 with total page 906 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book International Pharmacopoeia V 2 Quality Specifications written by and published by . This book was released on 1981 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Specifications for the Quality Control of Pharmaceutical Preparations written by and published by . This book was released on 1967 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
