美国
|
IN VIVO SCIENCES |
|
|
INSULIN BIOIDENTITY AND BIOPOTENCY |
USP <121> |
|
Validation of Analytical Procedures |
ICH Q2(R1) |
|
Immunogenicity Assays |
USP <1106> |
|
FDA |
21 CFR 600.3(s) |
|
Glucagon Bioidentity Tests |
USP <123> |
|
Somatropin Bioidentity Tests |
USP <126> |
|
Biological Reactivity Tests, In Vivo |
USP <88> |
|
Design and Analysis of Biological Assays |
USP <111> |
|
Bacteria Endotoxin Test |
USP <85> |
|
Pyrogen Test |
USP <151> |
|
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
ICH M3(R2) |
|
Biological Evaluation of Medical Devices – Part 1 Evaluation and testing within a risk management process |
ISO 10993-1 |
|
Biological Evaluation of Medical Devices – Part 2 Animal Welfare Requirements |
ISO 10993-2 |
|
Biological Evaluation of Medical Devices – Part 3 Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ISO 10993-3 |
|
Biological Evaluation of Medical Devices – Part 4 Selection of tests for interactions with blood |
ISO 10993-4 |
|
Biological Evaluation of Medical Devices – Part 5 Tests for in vitro cytotoxicity |
ISO 10993-5 |
|
Biological Evaluation of Medical Devices – Part 6 Tests for local affects after implantation |
ISO 10993-6 |
|
Biological Evaluation of Medical Devices – Part 7 Ethylene oxide sterilization residuals |
ISO 10993-7 |
|
Biological Evaluation of Medical Devices – Part 9 Framework for identification and quantification of potential degradation products |
ISO 10993-9 |
|
Biological Evaluation of Medical Devices – Part 10 Tests for irritation and skin sensitization |
ISO 10993-10 |
|
Biological Evaluation of Medical Devices – Part 11 Tests for systemic toxicity |
ISO 10993-11 |
|
Biological Evaluation of Medical Devices – Part 12 Sample preparation and reference materials |
ISO 10993-12 |
|
Biological Evaluation of Medical Devices – Part 13 Identification and quantification of degradation products from polymeric medical devices |
ISO 10993-13 |
|
Biological Evaluation of Medical Devices – Part 14 Identification and quantification of degradation products from ceramics |
ISO 10993-14 |
|
Biological Evaluation of Medical Devices – Part 15 Identification and quantification of degradation products from metals and alloys |
ISO 10993-15 |
|
Biological Evaluation of Medical Devices – Part 16 Toxicokinetic study design for degradation products and leachables |
ISO 10993-16 |
|
Biological Evaluation of Medical Devices – Part 17 Establishment of allowable limits for leachable substances |
ISO 10993-17 |
|
Biological Evaluation of Medical Devices – Part 18 Chemical characterization of materials |
ISO 10993-18 |
|
Biological Evaluation of Medical Devices – Part 19 Physico-chemical, morphological and topographical characterization of materials |
ISO/TS 10993-19 |
|
Biological Evaluation of Medical Devices – Part 20 Principles and methods for immunotoxicology testing of medical devices |
ISO/TS 10993-20 |
|
Biological Evaluation of Medical Devices – Part 22 Guidance on nanomaterials |
ISO/TS 10993-22 |
|
Biological Evaluation of Medical Devices – Part 23 Test for irritation |
ISO/TS 10993-23 |
|
Biological Evaluation of Medical Devices – Part 33 Guidance on tests to evaluate genotoxicity – supplement to ISO 10993-3 |
ISO/TR 10993-33 |
|
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
ICH S6 |
|
ANALYTICAL / BIOANALYTICAL CHEMISTRY |
|
|
Chromatography |
USP <621> |
|
Mass Spectrometry |
USP <736> |
|
Ultraviolet-Visible Spectroscopy |
USP <857> |
|
Mid-Infrared Spectroscopy |
USP <854> |
|
Spectrophotometric Identification Tests |
USP <197> |
|
Thin-Layer Chromatographic Identification Test |
USP <201> |
|
Impurities in New Drug Products |
ICH Q3A(R2) |
|
Impurities in New Drug Products |
ICH Q3B(R2) |
|
Polyacrylamide Gel Electrophoresis |
USP <1056> |
|
Immunoblot Analysis |
USP <1104> |
|
Enzyme-Linked Immunosorbent Assay (ELISA) |
USP <1103> |
|
Product Quality Tests |
USP <1> |
|
Visible Particulates in Injections |
USP <790> |
|
pH |
USP <791> |
|
Water Determination |
USP <921> |
|
Osmolality |
USP <785> |
|
Viscosity – Rotational Methods |
USP <912> |
|
Optical Rotation |
USP <781> |
|
Atomic Absorption Spectroscopy |
USP <852> |
|
Growth Factors and Cytokines Used in Cell Therapy Manufacturing |
USP <92> |
|
Validation of Analytical Procedures |
ICH Q2(R1) |
|
Cellular and Tissue-Based Products |
USP <1046> |
|
Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems |
USP <1663> |
|
Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems |
USP <1664> |
|
Plastic Packaging Systems and Their Materials of Construction |
USP <661> |
|
Plastic Materials of Construction |
USP <661.1> |
|
Plastic Packaging Systems for Pharmaceutical Use |
USP <661.2> |
|
Stability Testing of New Drug Substances and Products |
ICH Q1A(R2) |
|
Elemental Impurities – Limits |
USP <232> |
|
Elemental Impurities – Procedures |
USP <233> |
|
Guideline for Elemental Impurities |
ICH Q3D |
|
Test Procedures and Acceptance Criteria for Biotechnological/Biological Products |
ICH Q6B |
|
Analysis of the Expression Construct in Cells used for Production of R-DNA Derived Protein Products |
ICH Q5B |
|
Derivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products |
ICH Q5D |
|
Stability Testing of New Drug Substances and Products |
ICH Q1A(R2) |
|
Stability Testing of Biotechnological/Biological Products |
ICH Q5C |
|
Validation of Compendial Procedures |
USP <1225> |
|
Design and Validation of Immunoassays to Detect Anti-Drug Antibodies |
USP <1106> |
|
Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process |
ISO 10993-1 |
|
Biological Evaluation of Medical Devices – Part 17: Establishment of allowable limits for leachable substances |
ISO 10993-17 |
|
Biological Evaluation of Medical Devices – Part 18: Chemical characterization of medical device materials within a risk management process |
ISO 10993-18 |
|
Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products |
ASTM D6499-16 |
|
Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood |
ISO 10993-4 |
|
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
ASTM F1984-999(2018) |
|
Design and Validation of assays to Detect Anti-Drug Neutralizing Antibodies |
USP <1106.1> |
|
MICROBIOLOGY |
|
|
Tests for in vitro cytotoxicity |
ISO 10993-5 |
|
Biological Reactivity Tests, In Vitro |
USP <87> |
|
Bacteria Endotoxin Test |
USP <85> |
|
Pyrogen Test |
USP <151> |
|
Microbiological Examination of Nonsterile Products Microbial Enumeration Tests |
USP <61> |
|
Microbiological Examination of Nonsterile Products Tests for Specified Microorganisms |
USP <62> |
|
Microbiological Examination of Nonsterile Products - Tests for Burkholderia cepacia Complex |
USP <60> |
|
Sterility Tests |
USP <71> |
|
Water for Pharmaceutical Purposes |
USP <1231> |
|
Total Organic Carbon |
USP <643> |
|
Water Conductivity |
USP <645> |
|
Test Method Selection and Validation |
USP <1207.1> |
|
Package Integrity Leak Test Technologies |
USP <1207.2> |
|
Validation of Analytical Procedures Text and Methodology |
ICH Q2(R1) |
|
Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method |
ASTM D 4991-07 |
|
Antimicrobial Effectiveness Testing |
USP <51> |
|
Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure |
ASTM E 2315-16 |
|
Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 11135 |
|
Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices |
ISO 17664 |
|
Sterilization of health care products – Moist heat – Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 17665-1 |
|
Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1 |
ISO/TS 17665-2 |
|
Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers |
AAMI TIR No. 12:2020 |
|
Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
ANSI/AAMI ST79 |
|
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device Packages |
ASTM F1980-16 |
|
Ophthalmic Optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses |
ISO 14729 |
|
Sterilization of health care products – Radiation – Part 1: Requirements or development, validation and routine control of a sterilization process for medical devices |
ANSI/AAMI/ISO 11137-1 |
|
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose |
ANSI/AAMI/ISO 11137-2 |
|
Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration |
ISO 14644-1 |
|
Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
ISO 14644-2 |
|
Microbiological Control and Monitoring of Aseptic Processing Environments |
USP <1116> |
|
Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems |
ISO 11607-1 |