Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-eighth meeting report / / World Health Organization
| WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-eighth meeting report / / World Health Organization |
| Pubbl/distr/stampa | Geneva, Switzerland : , : World Health Organization, , 2014 |
| Descrizione fisica | 1 online resource (401 p.) |
| Disciplina | 615.1 |
| Collana | WHO Technical Report Series |
| Soggetto topico |
Drugs - Specifications
Drugs - Standards Pharmaceutical preparations - Standards Pharmaceutical technology - Standards |
| Soggetto genere / forma | Electronic books. |
| ISBN | 92-4-069254-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Contents; WHO Expert Committee on Specifications for Pharmaceutical Preparations; 1. Introduction; 2. General policy; 2.1 Cross-cutting pharmaceutical quality assurance issues; 2.1.1 Update from the Expert Committee on the Selection and Use of Essential Medicines; 2.1.2 Update from the Expert Committee on Biological Standardization; 2.1.3 Temperature mapping of a storage area; 2.2 International collaboration; 2.2.1 Collaboration with international organizations and agencies; 2.2.2 Pharmacopoeial Discussion Group
2.2.3 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)2.2.4 International Conference of Drug Regulatory Authorities; 3. Quality control - specifications and tests; 3.1 The International Pharmacopoeia; 3.1.1 Monographs under elaboration; 3.1.2 Monographs proposed for elaboration or withdrawal from The International Pharmacopoeia; 3.2 Specifications for medicines, including children's medicines; 3.2.1 Maternal, newborn, child and adolescent health medicines; 3.2.2 Antimalarial medicines; 3.2.3 Antiviral medicines 3.2.4 Antituberculosis medicines3.2.5 Medicines for neglected tropical diseases; 3.2.6 Other anti-infective medicines; 3.2.7 Other medicines; 3.3 General monographs for dosage forms and associated method texts; 3.3.1 Supplementary information; 3.3.2 Reagents, test solutions and volumetric solutions; 3.3.3 General policy; 3.3.4 Radiopharmaceuticals; 4. Quality control - International Reference Materials (International Chemical Reference Substances and Infrared Reference Spectra); 4.1 Update on International Chemical Reference Substances; 4.1.1 Overview 4.1.2 Release procedure for International Chemical Reference Substances4.1.3 Report from the ICRS Board; 4.1.4 Draft chapter on reference substances and reference spectra for the Supplementary information section of The International Pharmacopoeia; 4.1.5 International Chemical Reference Substances - miscellaneous topics; 4.2 Report of the custodian centre for ICRS; 4.2.1 Annual report; 4.2.2 Update on the annual report; 5. Quality control - national laboratories; 5.1 External Quality Assurance Assessment Scheme; 5.1.1 Final report on EQAAS 5.6; 5.1.2 Preliminary report on EQAAS 5.7 5.1.3 EQAAS Phase 6 proposals5.2 Networking; 5.3 Training materials for quality control laboratories and microbiological laboratories; 6. Quality assurance - good manufacturing practices; 6.1 Updates of WHO good manufacturing practices; 6.2 Update of WHO good manufacturing practices: validation; 6.3 General guidance for inspectors on "hold-time" studies; 6.4 Training materials; 7. Quality assurance - new initiatives; 7.1 International meetings of world pharmacopoeias; 7.2 Good pharmacopoeial practices; 7.3 FIP-WHO technical guidelines; 7.4 Screening technologies for "suspect" medicines 7.5 Laboratory functions survey regarding testing of spurious/falsely-labelled/falsified/counterfeit medical products |
| Record Nr. | UNINA-9910464531403321 |
| Geneva, Switzerland : , : World Health Organization, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-eighth meeting report / / World Health Organization
| WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-eighth meeting report / / World Health Organization |
| Pubbl/distr/stampa | Geneva, Switzerland : , : World Health Organization, , 2014 |
| Descrizione fisica | 1 online resource (401 p.) |
| Disciplina | 615.1 |
| Collana | WHO Technical Report Series |
| Soggetto topico |
Drugs - Specifications
Drugs - Standards Pharmaceutical preparations - Standards Pharmaceutical technology - Standards |
| ISBN | 92-4-069254-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Contents; WHO Expert Committee on Specifications for Pharmaceutical Preparations; 1. Introduction; 2. General policy; 2.1 Cross-cutting pharmaceutical quality assurance issues; 2.1.1 Update from the Expert Committee on the Selection and Use of Essential Medicines; 2.1.2 Update from the Expert Committee on Biological Standardization; 2.1.3 Temperature mapping of a storage area; 2.2 International collaboration; 2.2.1 Collaboration with international organizations and agencies; 2.2.2 Pharmacopoeial Discussion Group
2.2.3 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)2.2.4 International Conference of Drug Regulatory Authorities; 3. Quality control - specifications and tests; 3.1 The International Pharmacopoeia; 3.1.1 Monographs under elaboration; 3.1.2 Monographs proposed for elaboration or withdrawal from The International Pharmacopoeia; 3.2 Specifications for medicines, including children's medicines; 3.2.1 Maternal, newborn, child and adolescent health medicines; 3.2.2 Antimalarial medicines; 3.2.3 Antiviral medicines 3.2.4 Antituberculosis medicines3.2.5 Medicines for neglected tropical diseases; 3.2.6 Other anti-infective medicines; 3.2.7 Other medicines; 3.3 General monographs for dosage forms and associated method texts; 3.3.1 Supplementary information; 3.3.2 Reagents, test solutions and volumetric solutions; 3.3.3 General policy; 3.3.4 Radiopharmaceuticals; 4. Quality control - International Reference Materials (International Chemical Reference Substances and Infrared Reference Spectra); 4.1 Update on International Chemical Reference Substances; 4.1.1 Overview 4.1.2 Release procedure for International Chemical Reference Substances4.1.3 Report from the ICRS Board; 4.1.4 Draft chapter on reference substances and reference spectra for the Supplementary information section of The International Pharmacopoeia; 4.1.5 International Chemical Reference Substances - miscellaneous topics; 4.2 Report of the custodian centre for ICRS; 4.2.1 Annual report; 4.2.2 Update on the annual report; 5. Quality control - national laboratories; 5.1 External Quality Assurance Assessment Scheme; 5.1.1 Final report on EQAAS 5.6; 5.1.2 Preliminary report on EQAAS 5.7 5.1.3 EQAAS Phase 6 proposals5.2 Networking; 5.3 Training materials for quality control laboratories and microbiological laboratories; 6. Quality assurance - good manufacturing practices; 6.1 Updates of WHO good manufacturing practices; 6.2 Update of WHO good manufacturing practices: validation; 6.3 General guidance for inspectors on "hold-time" studies; 6.4 Training materials; 7. Quality assurance - new initiatives; 7.1 International meetings of world pharmacopoeias; 7.2 Good pharmacopoeial practices; 7.3 FIP-WHO technical guidelines; 7.4 Screening technologies for "suspect" medicines 7.5 Laboratory functions survey regarding testing of spurious/falsely-labelled/falsified/counterfeit medical products |
| Record Nr. | UNINA-9910786623203321 |
| Geneva, Switzerland : , : World Health Organization, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-eighth meeting report / / World Health Organization
| WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-eighth meeting report / / World Health Organization |
| Pubbl/distr/stampa | Geneva, Switzerland : , : World Health Organization, , 2014 |
| Descrizione fisica | 1 online resource (401 p.) |
| Disciplina | 615.1 |
| Collana | WHO Technical Report Series |
| Soggetto topico |
Drugs - Specifications
Drugs - Standards Pharmaceutical preparations - Standards Pharmaceutical technology - Standards |
| ISBN | 92-4-069254-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover; Contents; WHO Expert Committee on Specifications for Pharmaceutical Preparations; 1. Introduction; 2. General policy; 2.1 Cross-cutting pharmaceutical quality assurance issues; 2.1.1 Update from the Expert Committee on the Selection and Use of Essential Medicines; 2.1.2 Update from the Expert Committee on Biological Standardization; 2.1.3 Temperature mapping of a storage area; 2.2 International collaboration; 2.2.1 Collaboration with international organizations and agencies; 2.2.2 Pharmacopoeial Discussion Group
2.2.3 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)2.2.4 International Conference of Drug Regulatory Authorities; 3. Quality control - specifications and tests; 3.1 The International Pharmacopoeia; 3.1.1 Monographs under elaboration; 3.1.2 Monographs proposed for elaboration or withdrawal from The International Pharmacopoeia; 3.2 Specifications for medicines, including children's medicines; 3.2.1 Maternal, newborn, child and adolescent health medicines; 3.2.2 Antimalarial medicines; 3.2.3 Antiviral medicines 3.2.4 Antituberculosis medicines3.2.5 Medicines for neglected tropical diseases; 3.2.6 Other anti-infective medicines; 3.2.7 Other medicines; 3.3 General monographs for dosage forms and associated method texts; 3.3.1 Supplementary information; 3.3.2 Reagents, test solutions and volumetric solutions; 3.3.3 General policy; 3.3.4 Radiopharmaceuticals; 4. Quality control - International Reference Materials (International Chemical Reference Substances and Infrared Reference Spectra); 4.1 Update on International Chemical Reference Substances; 4.1.1 Overview 4.1.2 Release procedure for International Chemical Reference Substances4.1.3 Report from the ICRS Board; 4.1.4 Draft chapter on reference substances and reference spectra for the Supplementary information section of The International Pharmacopoeia; 4.1.5 International Chemical Reference Substances - miscellaneous topics; 4.2 Report of the custodian centre for ICRS; 4.2.1 Annual report; 4.2.2 Update on the annual report; 5. Quality control - national laboratories; 5.1 External Quality Assurance Assessment Scheme; 5.1.1 Final report on EQAAS 5.6; 5.1.2 Preliminary report on EQAAS 5.7 5.1.3 EQAAS Phase 6 proposals5.2 Networking; 5.3 Training materials for quality control laboratories and microbiological laboratories; 6. Quality assurance - good manufacturing practices; 6.1 Updates of WHO good manufacturing practices; 6.2 Update of WHO good manufacturing practices: validation; 6.3 General guidance for inspectors on "hold-time" studies; 6.4 Training materials; 7. Quality assurance - new initiatives; 7.1 International meetings of world pharmacopoeias; 7.2 Good pharmacopoeial practices; 7.3 FIP-WHO technical guidelines; 7.4 Screening technologies for "suspect" medicines 7.5 Laboratory functions survey regarding testing of spurious/falsely-labelled/falsified/counterfeit medical products |
| Record Nr. | UNINA-9910809943303321 |
| Geneva, Switzerland : , : World Health Organization, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
WHO Expert Committee on Specifications for Pharmaceutical Preparations [[electronic resource] ] : thirty-seventh report
| WHO Expert Committee on Specifications for Pharmaceutical Preparations [[electronic resource] ] : thirty-seventh report |
| Pubbl/distr/stampa | Geneva, : World Health Organization, 2003 |
| Descrizione fisica | 1 online resource (145 p.) |
| Disciplina | 615.19 |
| Collana | WHO technical report series |
| Soggetto topico |
Drugs - Standards
Drugs - Specifications Pharmaceutical industry - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-01133-5
92-4-068157-4 9786610011339 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Introduction -- 2. General policy -- 3. Quality control--specifications and tests -- 4. Quality control--international reference materials -- 5. Quality control--national laboratories -- 6. Quality assurance--good manufacturing practices (GMP) -- 7. Quality assurance--inspection -- 8. Quality assurance--distribution and trade-related -- 9. Quality assurance--risk analysis -- 10. Quality assurance--drug supply -- 11. Quality assurance--storage -- 12. International Nonproprietary Names (INNs) Programme -- 13. Miscellaneous -- Annex 1. Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products -- Annex 2. The International Pharmacopoeia: revised concepts and future perspectives -- Annex 3. Guidelines on good manufacturing practices for radiopharmaceutical products -- Annex 4. Good manufacturing practices for pharmaceutial products: main prinicples -- Annex 5. Model certificate of good manufacturing practices -- Annex 6. Guidance on good manufacturing practices (GMP): inspection report -- Annex 7. Application of hazard analysis and critical control point (HACCP) method to pharmaceuticals -- Annex 8. Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies -- Annex 9. Guide to good storage practices for pharmaceuticals. |
| Record Nr. | UNINA-9910455616203321 |
| Geneva, : World Health Organization, 2003 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
WHO Expert Committee on Specifications for Pharmaceutical Preparations [[electronic resource] ] : thirty-seventh report
| WHO Expert Committee on Specifications for Pharmaceutical Preparations [[electronic resource] ] : thirty-seventh report |
| Pubbl/distr/stampa | Geneva, : World Health Organization, 2003 |
| Descrizione fisica | 1 online resource (145 p.) |
| Disciplina | 615.19 |
| Collana | WHO technical report series |
| Soggetto topico |
Drugs - Standards
Drugs - Specifications Pharmaceutical industry - Quality control |
| ISBN |
1-280-01133-5
92-4-068157-4 9786610011339 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Introduction -- 2. General policy -- 3. Quality control--specifications and tests -- 4. Quality control--international reference materials -- 5. Quality control--national laboratories -- 6. Quality assurance--good manufacturing practices (GMP) -- 7. Quality assurance--inspection -- 8. Quality assurance--distribution and trade-related -- 9. Quality assurance--risk analysis -- 10. Quality assurance--drug supply -- 11. Quality assurance--storage -- 12. International Nonproprietary Names (INNs) Programme -- 13. Miscellaneous -- Annex 1. Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products -- Annex 2. The International Pharmacopoeia: revised concepts and future perspectives -- Annex 3. Guidelines on good manufacturing practices for radiopharmaceutical products -- Annex 4. Good manufacturing practices for pharmaceutial products: main principles -- Annex 5. Model certificate of good manufacturing practices -- Annex 6. Guidance on good manufacturing practices (GMP): inspection report -- Annex 7. Application of hazard analysis and critical control point (HACCP) method to pharmaceuticals -- Annex 8. Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies -- Annex 9. Guide to good storage practices for pharmaceuticals. |
| Record Nr. | UNINA-9910780208103321 |
| Geneva, : World Health Organization, 2003 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
