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


US FDA Guidelines

 

COVID-19 가이드라인

1.

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)

2.

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

3.

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 (2022)

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

 

Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug or Device Inspection (draft) (2022. 12)

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: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing (draft)

28.

Guidance for Industry: Inspection of Injectable Products for Visible Particulates (draft)

29.

Guidance for Industry: Field Alert Report Submission: Questions and Answers

30.

Guidance for Industry: Questions and Answers on Quality Related Controlled Correspondence

31.

Guidance for Industry: Conducting Remote Regulatory Assessments: Questions and Answers

32.

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

33.

Guidance for Industry: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (Draft) New

 

 

 

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

20.

Guidance for Industry: ICH Q12: Implementation Considerations for FDA-Regulated Products (Draft)

21.

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

22.

Guidance for Industry: Changes to Disposable Manufacturing Materials: Questions and Answers

23.

Guidance for Industry: Setting Endotoxin Limits During Development of Invstigational Oncology Drugs and Biological Products

24.

Guidance for Industry: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens (Draft)

 

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 CP (Compliance Program)

1.

Program No. 7345.848 Inspection of Biological Drug Products

번역문(원문+번역문)

2.

Program No. 7346.832 Preapproval Inspections (2022)

번역문(원문+번역문) New

3.

Program No. 7356.002 Drug Manufacturing Inspections (2022)

번역문(원문+번역문) New

4.

Program No. 7356.002A Sterile Drug Process Inspections

번역문(원문+번역문)

5.

Program No. 7356.002F Active Pharmaceutical Ingredients

번역문(원문+번역문)

6.

Program No. 7356.002M Surveillance Inspections of Protein Drug Substance Manufacturers (2021)

번역문(원문+번역문) New

7.

Program No. 7356.843 Postapproval Inspections (2023)

번역문(원문+번역문) New

 

 

 

 

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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