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e-newsletter

 

 

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


US FDA Guidelines

 

 

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 on Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide

26

Guidance for Industry: Data Integrity and Compliance with CGMP (draft)

27

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

28

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

29

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

 

CMC 가이드

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

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

   
 

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  

   

 

 

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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