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COVID-19 가이드라인
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1.
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Guidance for Industry: Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
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GMP 가이드라인
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1.
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Guidance for Industry: Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
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2.
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Guidance for Industry: Process Validation: General Principles and Practices (2011)
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3.
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General
Principles of Software Validation: Final Guidance for Industry and FDA
Staf
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4.
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Guidance for Industry: Investigating Out of Specification (OOS)
Test Results for Pharmaceutical Production (2022)
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5.
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Guidance for Industry: Sterile Drug
Products Produced by Aseptic Processing - Current Good Manufacturing
Practice
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6.
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Guidance for Industry: Part 11, Electronic Records; Electronic
Signatures - Scope & Application
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7.
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Guideline on the Preparation of Investigational New Drug Products (Human and Animal)
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8.
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Guidance for Industry: CGMP for Phase I Investigational Drugs
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9.
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Guideline for Drug
Master File
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10.
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Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug
Substances
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11.
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Guidance for Industry: PAT – A Framework for
Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
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12.
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Guidance for Industry
& FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
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13.
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Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
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14.
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Guidance for Industry: Computerized Systems Used in Clinical Investigations
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15.
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Guidance for Industry: Non-Penicillin Beta-Lactam Risk
Assessment: A CGMP Framework
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16.
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Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers
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17.
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Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
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18.
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Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
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19.
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Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
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20.
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Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
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21.
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Guidance for Industry: Submission of Quality Metrics Data (draft)
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21-1.
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Quality Metrics Technical Conformance Guide (draft)
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22.
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Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
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23.
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Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Protein to a Reference Product
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24.
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Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug or Device Inspection (2024. 6) New
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25.
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Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
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26.
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Guidance for Industry: Data Integrity and Compliance with CGMP
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27.
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Guidance for Industry: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing (draft)
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28.
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Guidance for Industry: Inspection of Injectable Products for Visible Particulates (draft)
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29.
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Guidance for Industry: Field Alert Report Submission: Questions and Answers
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30.
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Guidance for Industry: Questions and Answers on Quality Related Controlled Correspondence
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| 31.
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Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for DEG and EG
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32.
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Guidance for Industry: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (Draft)
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33.
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Guidance for Industry: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities (Draft)
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34.
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Guidance for Industry: Conducting Remote Regulatory Assessments - Questions and Answers (Draft)
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35.
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Guidance for Industry: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (Draft)
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CMC 가이드라인
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1.
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Guidance for Indsutry: for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
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2.
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Guidance for Industry: Container Closure Systems for Packaging
Human Drugs and Biologics
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2-1.
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Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics: Questions and Answers
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3.
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Guidance for Industry: CMC Information for a Therapeutic
Recombinant DNA-derived Product or a Monoclonal Antibody Product for In Vivo
Use
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4.
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Guidance for Industry: ANDAs: Impurities in Drug Substancese
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5.
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Guidance for Industry: ANDAs: Impurities in Drug Products
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6.
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Guidance for Industry: Content
and Format of Chemistry, Manufacturing and Control Information and
Establishment Description Information for a Vaccine or Related Product
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7.
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Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
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8.
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Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States
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9.
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Guidance for Industry: Monoclonal
Antibodies Used As Reagents in Drug Manufacturing
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10.
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Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products
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11.
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Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics
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12.
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Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing, and Controls Documentations
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13.
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Guidance
for Industry: Content and Format of Chemistry, Manufacturing and Control
Information and Establishment Description Information for a Vaccine or Related
Product
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14.
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Guidance for Industry: Format and Content for the CMC Section of an Annual Report
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15.
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Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures
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16.
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Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products - Questions and Answers
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17.
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Guidance for Industry: Comparability Protocols for Postapproval Changes to the CMC Information in an NDA, ANDA or BLA
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18.
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Guidance for Industry: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
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19.
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Guidance for Industry: Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers
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20.
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Guidance for Industry: ICH Q12: Implementation Considerations for FDA-Regulated Products (Draft)
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21.
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Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
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22.
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Guidance for Industry: Changes to Disposable Manufacturing Materials: Questions and Answers
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23.
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Guidance for Industry: Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products
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24.
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Guidance for Industry: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens (Draft)
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25.
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Guidance for Industry: CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
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26.
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Guidance for Industry: Advanced Manufacturing Technologies Designation Program (draft)
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27.
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Guidance for Industry: Quality Considerations for Topical Ophthalmic Drug Products (draft) New
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실사 가이드
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1.
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Guide
to Inspections of Foreign Pharmaceutical Manufacturers
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2.
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Guide
to Inspections of Foreign Medical Device Manufacturers
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3.
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Guide to Inspections of Computerized Systems in Drug Establishments
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4.
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Guide
to Inspections of High Purity Water Systems
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5.
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Guide
to Inspections of Sterile Drug Substance Manufacturers
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6.
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Guide
to Inspections of Microbiologicla Pharmaceutical Quality Control
Laboratories
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7.
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Guide to
Inspections of Lyophilization of Parenterals
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8.
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Guide to
Inspections of Pharmaceutical Quality Control
Laboratories
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9.
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Guide to
Inspections of Validation of Cleaning Processes
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10.
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Guide to
Inspections of Dosage Form Drug Manufacturers
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11.
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Guide to
Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development
& Validation
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12.
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Guide to
Inspections of Topical Drug Products
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13.
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Guide to
Inspections of Oral Solutions and Suspensions
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14.
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Biotechnology
Inspection Guide: Reference Materials & Training
Aids
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15.
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Guide To Inspections of Viral Clearance Processes For Plasma
Derivatives
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FDA CP (Compliance Program)
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1.
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Program No. 7345.848 Inspection of Biological Drug Products
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번역문(원문+번역문)
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2.
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Program No. 7346.832 Preapproval Inspections (2022)
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번역문(원문+번역문)
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3.
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Program No. 7356.002 Drug Manufacturing Inspections (2022)
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번역문(원문+번역문)
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4.
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Program No. 7356.002A Sterile Drug Process Inspections
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번역문(원문+번역문)
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5.
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Program No. 7356.002F Active Pharmaceutical Ingredients
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번역문(원문+번역문)
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6.
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Program No. 7356.002M Surveillance Inspections of Protein Drug Substance Manufacturers (2021)
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번역문(원문+번역문)
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7.
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Program No. 7356.843 Postapproval Inspections (2023)
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번역문(원문+번역문)
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CPG
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Sec. 130.300 FDA Access to Results of Quality
Assurance Program Audits and Inspections (CPG 7151.02)
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Sec.425.100 Computerized Drug Processing; CGMP Applicability To
Hardware and Software (CPG 7132a.11)
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Sec.425.200 Computerized Drug Processing; Vendor Responsibility
(CPG 7132a.12)
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Sec.425.300 Computerized Drug Processing; Source Code for Process
Control Application Programs (CPG 7132a.15)
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Sec.425.400 Computerized Drug Processing; Input/Output Checking
(CPG 7132a.07)
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Sec.425.500 Computerized Drug Processing; Identification of
"Persons" on Batch Production and Control Records (CPG 7132a.08)
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Sec.490.100 Process Validation Requirements for Drug Products &
Active Pharmaceutical Ingredients Subject to Pre-Market Approval (CPG
7132c.08)
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