Requirements on reference standards of chemically defined substances from a regulatory point of view;Anforderungen an referenzstandards chemisch definierter substanzen aus regulatorischer sicht

Pharmazeutische Industrie

Volumn 72, Issue 12, 2010, Pages 2037-2042

  Belz, Susanne ^a   Wippo, Ursula ^a   Nopitsch Mai, Cornelia ^a  

^a Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG CONTROL; STANDARD;

EID: 78651289872     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (21)

1. ISO Guide 30. Terms and definitions used in connection with reference materials. 1992.
2. ISO Guide 31. Reference materials. Contents of certificates and labels. 2000.
3. ISO Guide 32. Calibration in analytical chemistry and use of certified reference materials. 1997.
4. ISO Guide 33. Uses of certified reference material. 2000.
5. ISO Guide 34. General requirements for the competence of reference material producers. 2009.
6. ISO Guide 35. Reference materials. General and statistical principles for certification. 2006.
7. The rules governing medicinal products in the European Union (EudraLex). Volume 2B. Notice to Applicants. Presentation and Content of the Dossier.
8. The rules governing medicinal products in the European Union (EudraLex). Volume 3A. Quality and Biotechnology.
9. Guideline on Validation of Analytical Procedures: Definitions and Terminology (CPMP/ICH/381/95, ICH Q2A). Aug 2003.
10. Note for guidance on specifications: Test procedures and acceptance criteria for new drug products. Chemical substances (CPMP/ICH/367/96 corr, ICH Q6A). May 2000.
11. Note for guidance on Good manufacturing Practice for active pharmaceutical ingredients (CHMP/ICH/4106/00, ICH Q7). Nov 2000.
12. Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (CPMP/ICH/138/95 ICH 5QC). July 1996.
13. Food and Drug Administration. Guidance for Industry (draft). Analytical Procedures and Methods Validation. August 2000. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122858.pdf
14. Food and Drug Administration. Guidance for Industry. Bioanalytical Method Validation. May 2001. http://www.fda.gov/downloads/Drugs/GuidanceCompliance- RegulatoryInformation/Guidances/UCM070107.pdf
15. The rules governing medicinal products in the European Union (EudraLex). Volume 3A. Quality and Biotechnology.
16. Guideline on Validation of Analytical Procedures: Definitions and Terminology (CPMP/ICH/381/95, ICH Q2A). Aug 2003.
17. Note for guidance on specifications: Test procedures and acceptance criteria for new drug products. Chemical substances (CPMP/ICH/367/96 corr, ICH Q6A). May 2000.
18. Note for guidance on Good manufacturing Practice for active pharmaceutical ingredients (CHMP/ICH/4106/00, ICH Q7). Nov 2000.
19. Quality of Biotechnological Products: Stability Testing of Biotechnological/ Biological Products (CPMP/ICH/138/95 ICH 5QC). July 1996.
20. Food and Drug Administration. Guidance for Industry (draft). Analytical Procedures and Methods Validation. August 2000. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122858.pdf
21. Food and Drug Administration. Guidance for Industry. Bioanalytical Method Validation. May 2001. http://www.fda.gov/downloads/Drugs/GuidanceCompliance- RegulatoryInformation/Guidances/UCM070107.pdf