03843nam 2200601Ia 450 991045561620332120200520144314.01-280-01133-592-4-068157-49786610011339(CKB)111087027685714(EBL)284793(OCoLC)191039475(SSID)ssj0000271407(PQKBManifestationID)11192927(PQKBTitleCode)TC0000271407(PQKBWorkID)10293689(PQKB)10729267(MiAaPQ)EBC284793(Au-PeEL)EBL284793(CaPaEBR)ebr10040297(EXLCZ)9911108702768571420030508d2003 uh 0engur|n|---|||||txtccrWHO Expert Committee on Specifications for Pharmaceutical Preparations[electronic resource] thirty-seventh reportGeneva World Health Organization20031 online resource (145 p.)WHO technical report series,0512-3054 ;908Description based upon print version of record.92-4-120908-9 0-585-49271-9 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.This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guideliTechnical report series (World Health Organization) ;908.DrugsStandardsCongressesDrugsSpecificationsCongressesPharmaceutical industryQuality controlCongressesElectronic books.DrugsStandardsDrugsSpecificationsPharmaceutical industryQuality control615.19MiAaPQMiAaPQMiAaPQBOOK9910455616203321WHO Expert Committee on Specifications for Pharmaceutical Preparations1917970UNINA00762nam0 2200265 450 991105572970332120260123085211.0978 88386131337120260123d2025---- kmyy0itay50 baitaITy 001yyStrumenti per il nostro futurosostenibilità climatica e mercati finanziariMario NoeraMilanoMcGraw-Hill2025XIV, 628 p.22 cmDiscipline aziendali332.6094NoeraMario749196ITUNINAREICATUNIMARCBK9911055729703321AZTIF188A$b 6633DECBCDECBCStrumenti per il nostro futuro4531372UNINA