CMC指导原则列表

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Chemistry, Manufacturing, and Controls (CMC)

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm

Below is a sortable table of Chemistry, Manufacturing and Controls (CMC) Guidances:-

Category

Title

Type Date

Chemistry,

Manufacturing, and Controls (CMC) Chemistry,

Manufacturing, and Controls (CMC); Modernization Act Chemistry,

Manufacturing, and Controls (CMC) Chemistry,

Manufacturing, and Controls (CMC)

Analytical Procedures and Methods Validation (PDF - Draft

91KB)1 Guidance Assay Development for Immunogenicity Testing of Draft

Therapeutic Proteins (PDF - Guidance 161KB)2

Botanical Drug Products (PDF - Final

437KB)3

Guidance

Changes to an Approved Application for Specified Biotechnology and Specified Final

Synthetic Biological Guidance

Products (PDF - 33KB)4

Changes to an Approved NDA or Final ANDA (PDF - 108KB)5 Guidance Changes to an Approved NDA or ANDA: Questions and Final

Answers (PDF - 35KB)6

Guidance

Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Final

Compendial Changes (PDF - Guidance

18KB)7

CMC Postapproval Manufacturing Changes Reportable in Annual Draft

Reports (PDF - 78KB)8 Guidance

Comparability Protocols -- Chemistry, Manufacturing, and Draft

Controls Information (PDF - Guidance

240KB)9

08/30/00

12/04/09

06/01/04

07/01/97

04/01/04

01/01/01

11/19/04

06/24/10

02/25/03

Chemistry,

Manufacturing, and Controls (CMC) Chemistry,

Manufacturing, and Controls (CMC)

Chemistry,

Manufacturing and Controls (CMC) Chemistry,

Manufacturing, and Controls (CMC) Chemistry,

Manufacturing, and Controls (CMC)

Container Closure Systems for Packaging Human Drugs and Final

Biologics (PDF - 164KB)10 Guidance Container Closure Systems for Packaging Human Drugs and Final

Biologics -- Questions and Guidance

Answers (PDF - 15KB)11 Demonstration of Comparability of Human Biological Products, Final Including Therapeutic Guidance Biotechnology-derived Products12 Development of New Final

Stereoisomeric Drugs13

Guidance

Guideline for Drug Master Files14 Additional Drug Master Files (DMFs)15

Information regarding DMF's

Drug Master Files for Bulk Antibiotic Drug Substances (PDF - Final

23KB)16

Guidance

Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Draft

Humans and Animals (PDF - Guidance

88KB)17

Environmental Assessment of Human Drug and Biologics Final

Applications (PDF - 188KB)18

Guidance

Format and Content for the CMC Section of an Annual Report (PDF Final

- 29KB)19 Guidance

Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Draft

Products for Guidance

Anticounterfeiting (PDF - 79KB)20

INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, Final

and Controls Information (PDF - Guidance 193KB)21

05/01/99

05/01/02

04/01/96

05/01/92

11/01/99

09/11/02

07/01/98

09/01/94

07/14/09

05/20/03

Chemistry,

Manufacturing, and Controls (CMC)

Chemistry,

Manufacturing, and Controls (CMC) Chemistry,

IND Meetings for Human Drugs and Biologics Chemistry, Final

Manufacturing, and Controls Guidance

Information (PDF - 30KB)22

Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB)23

Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Draft Pharmacokinetics and Guidance Bioavailability; and Labeling Documentation (PDF - 45KB)24 Monoclonal Antibodies Used as Reagents in Drug Final

Manufacturing (PDF - 29KB)25

Guidance

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Draft

Products (PDF - 361KB)26 Guidance

Nasal Spray and Inhalation Solution, Suspension, and Drug Final

Products (PDF - 116KB)27 Guidance NDAs: Impurities in Drug Final

Substances (PDF - 11KB)28

Guidance

Orally Disintegrating Tablets (PDF Final - 52KB)29 Guidance PAC-ATLS: Postapproval Changes - Analytical Testing Final

Laboratory Sites (PDF - 76KB)30

Guidance

Residual Drug in Transdermal and Related Drug Delivery Final

Systems (PDF - 44KB)31 Guidance

Residual Solvents in Drug Products Marketed in the United Final

States (PDF - 52KB)32

Guidance

Reviewer Guidance, Validation of Chromatographic Methods (PDF - Final

703KB)33 Guidance

Size of Beads in Drug Products Draft

05/01/01

08/21/02

03/01/01

11/19/98

07/01/02

02/01/00

12/17/08

04/28/98

08/16/11

11/24/09

11/01/94 01/18/11

Manufacturing, and Controls (CMC) Chemistry,

Manufacturing, and Controls (CMC)

Chemistry,

Manufacturing, and Controls (CMC)

Chemistry,

Manufacturing, and Controls (CMC) Chemistry,

Manufacturing, and Controls (CMC)

Chemistry,

Manufacturing, and Controls (CMC)

Chemistry,

Manufacturing, and Controls (CMC) Chemistry,

Labeled for Sprinkle (PDF - Guidance

43KB)34

Submitting Documentation for the Manufacturing of and Controls for Final

Drug Products (PDF - 1048KB)35

Guidance

Guidelines for Submitting Samples and Analytical Data for Methods Final

Validation36 Guidance

Submitting Supporting Documentation in Drug Applications for the Manufacture Final

of Drug Substances (PDF - Guidance

94KB)37 SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Final Manufacturing and Controls, In Guidance Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF - 60KB)38 SUPAC-IR Questions and Answers about SUPAC-IR Final

Guidance39

Guidance

SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Final

Manufacturing Equipment Guidance

Addendum (PDF - 117KB)40

SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Final Controls; In Vitro Dissolution Guidance Testing and In Vivo Bioequivalence Documentation (PDF - 215KB)41

SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Draft Equipment Addendum (PDF - Guidance 61KB)42

SUPAC-SS: Nonsterile Semisolid Final

02/01/87

11/01/95

02/18/97

01/01/99

10/06/97

12/01/98 05/01/97

Manufacturing, and Dosage Forms; Scale-Up and Guidance Controls (CMC)

Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF - 118KB)43

Guidance for Industry - The Sourcing and

Processing of Gelatin to

The Sourcing and Processing of Reduce the Potential

Gelatin to Reduce the Potential Risk Posed by Bovine

Risk Posed by Bovine Spongiform Spongiform

Encephalopathy (BSE) in

Encephalopathy (BSE)

FDA-Regulated Products for in FDA-Regulated

Human Use44

Products for Human Use Chemistry,

Tablet Scoring:Nomenclature, Manufacturing, and Labeling, and Data for Draft

Controls (CMC)

Evaluation (PDF - 99KB)45

Guidance

09/01/97 08/29/11

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