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Pyrogenicity |
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U.S. Food and Drug Administration
- U.S. Code of Federal Regulations (CFR):
- 21CFR211.167 - Current Good Manufacturing Practice for Finished
Pharmaceuticals: Special Testing Requirements [PDF]
- 21CFR610.13 - General Biological Products Standards: Purity [PDF]
- 21CFR610.9 - General Provisions: Equivalent methods and processes [PDF]
- Guideline on Validation of the Limulus Amebocyte Lysate Test
as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products,
and Medical Devices (December 1987) [PDF]
- Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
(November 2007) [PDF]
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (April 2008) [PDF]
- Guidance for FDA Reviewers and Sponsors: Instructions and Template for Chemistry,
Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational
New Drug Applications (INDs) (April 2008) [PDF]
- Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance:
Preparation of a Premarket Notification Application for a Surgical Mesh (March 1999) [PDF]
International Organization for Standardization (ISO)
- ISO 10993-11 - Biological evaluation of medical devices -
Part 11: Tests for systemic toxicity (First edition 1993-12-15)
United States Pharmacopeia (USP) 28-NF23
- (85) - Bacterial Endotoxins Test [PDF]
- (151) - Pyrogen Test [PDF]
- (1041) - Biologics [PDF]
European Pharmacopoeia 5.0
- 2.6.8. Pyrogens [PDF]
- 2.6.14. Bacterial Endotoxins [PDF]
European Pharmacopoeia 5.2
- 07/2005:0520 Parenteral Preparations [PDF]
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