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) Chemistry,
Manufacturing, and Controls (CMC) Chemistry,
Manufacturing, and Controls (CMC) Chemistry,
Manufacturing, and Controls (CMC); Modernization Act Chemistry,
Manufacturing, and Controls (CMC) Chemistry,
Manufacturing, and Controls (CMC) 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) 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)
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,
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,
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,
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
02/01/87
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