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e-newsletter

 

 

GMP Case Study: Lessons from FDA 483s & Warning Letters


US FDA Guidelines

 

COVID-19 가이드라인

1

Guidance for Industry: GMP Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing

2

Guidance for Industry: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency: Questions and Answers (updated on May 17, 2021)

3

Guidance for Industry: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

4

Guidance for Industry: Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency

5

Guidance for Industry: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency

 

GMP 가이드라인

1

Guidance for Industry: Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

2

Guideline on General Principles of Process Validation (1987)

 

Guidance for Industry: Process Validation: General Principles and Practices (2011)

3

General Principles of Software Validation: Final Guidance for Industry and FDA Staff

4

Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production

5

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice

6

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope & Application

7

Guideline on the Preparation of Investigational New Drug Products (Human and Animal)

8

Guidance for Industry: CGMP for Phase I Investigational Drugs

9

Guideline for Drug Master File

10

Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances

11

Guidance for Industry: PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

12

Guidance for Industry & FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

13

Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

14

Guidance for Industry: Computerized Systems Used in Clinical Investigations

15

Guidance for Industry: Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework

16

Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers

17

Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility

18

Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements

19

Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality

20

Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

21

Guidance for Industry: Submission of Quality Metrics Data (draft)

21-1

Quality Metrics Technical Conformance Guide (draft)

22

Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

23

Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Protein to a Reference Product

24

Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection

25

Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

26

Guidance for Industry: Data Integrity and Compliance with CGMP

27

Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

 

CMC 가이드라인

1

Guidance for Indsutry: for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products

2

Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics

2-1

Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics: Questions and Answers

3

Guidance for Industry: CMC Information for a Therapeutic Recombinant DNA-derived Product or a Monoclonal Antibody Product for In Vivo Use

4

Guidance for Industry: ANDAs: Impurities in Drug Substancese

5

Guidance for Industry: ANDAs: Impurities in Drug Products

6

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Control Information and Establishment Description Information for a Vaccine or Related Product

7

Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes

8

Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States

9

Guidance for Industry: Monoclonal Antibodies Used As Reagents in Drug Manufacturing

10

Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products

11

Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics

12

Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing, and Controls Documentations

13

Guidance for Industry: Content and Format of Chemistry, Manufacturing and Control Information and Establishment Description Information for a Vaccine or Related Product

14

Guidance for Industry: Format and Content for the CMC Section of an Annual Report

15

Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures

16

Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products - Questions and Answers

17

Guidance for Industry: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information (Draft)

18

Guidance for Industry: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products

19

Guidance for Industry: Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers New

 

실사 가이드

1

Guide to Inspections of Foreign Pharmaceutical Manufacturers

2

Guide to Inspections of Foreign Medical Device Manufacturers

3

Guide to Inspections of Computerized Systems in Drug Processing

4

Guide to Inspections of High Purity Water Systems

5

Guide to Inspections of Sterile Drug Substance Manufacturers

6

Guide to Inspections of Microbiologicla Pharmaceutical Quality Control Laboratories 

7

Guide to Inspections of Lyophilization of Parenterals

8

Guide to Inspections of Pharmaceutical Quality Control Laboratories

9

Guide to Inspections of Validation of Cleaning Processes

10

Guide to Inspections of Dosage Form Drug Manufacturers

11

Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development & Validation

12

Guide to Inspections of Topical Drug Products

13

Guide to Inspections of Oral Solutions and Suspensions

14

Biotechnology Inspection Guide: Reference Materials & Training Aids

15

Guide To Inspections of Viral Clearance Processes For Plasma Derivatives  

 

 

 

 

FDA CPGM(Compliance Program Guidance Manual)

1

Program No. 7356.002 Drug Manufacturing Inspections

번역문(원문+번역문)

2

Program No. 7356.002F Active Pharmaceutical Ingredients

번역문(원문+번역문)

3

Program No. 7356.002A Sterile Drug Process Inspections

번역문(원문+번역문)

4

Program No. 7345.848 Inspection of Biological Drug Products

번역문(원문+번역문)

5

Program No. 7346.832 Preapproval Inspections

번역문(원문+번역문)

   

 

 

CPG

 

Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)

 

Sec.425.100 Computerized Drug Processing; CGMP Applicability To Hardware and Software (CPG 7132a.11)

 

Sec.425.200 Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)

 

Sec.425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (CPG 7132a.15)

 

Sec.425.400 Computerized Drug Processing; Input/Output Checking (CPG 7132a.07)

 

Sec.425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records (CPG 7132a.08)

 

Sec.490.100 Process Validation Requirements for Drug Products & Active Pharmaceutical Ingredients Subject to Pre-Market Approval (CPG 7132c.08)

   

 


 

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