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Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice








Part I - Basic Requirements for Medicinal Products

Chapter 1

Pharmaceutical Quality System (2013년 1월 31일 시행)

Chapter 2

Personnel (2014년 2월 16일 시행)

Chapter 3

Premises and Equipment (2015년 3월 1일 시행)

Chapter 4

Documentation (revision January 2011)

Chapter 5

Production (2015년 3월 1일 시행)

Chapter 6

Quality Control (2014년 10월 1일 시행)

Chapter 7

Outsourced Activities (2013년 1월 31일 시행)

Chapter 8

Complaints, Quality Defects and Product Recalls (2015년 3월 1일 시행)

Chapter 9

Self Inspection




Part II - Basic Requirements for Active Substances used as Starting Materials


Basic Requirements for Active Substances used as Starting Materials (2014년 9월 1일 시행)




Part III - GMP Related Documents


Site Master File


Q9 Quality Risk Management


Q10 Note for Guidance on Pharmaceutical Quality System


MRA Batch Certificate


Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use


Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities


Guideline of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use





Annex 1

Manufacture of Sterile Medicinal Products (revision November 2008)


Manufacture of Sterile Medicinal Products (draft, February 2020)

Annex 2

Manufacture of Biological Medicinal Products for Human Use (26 June 2018)

Annex 3

Manufacture of Radiopharmaceuticals

Annex 4

Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

Annex 5

Manufacture of Immunological Venterinary Medicinal Products

Annex 6

Manufacture of Medicinal Gases

Annex 7

Manufacture of Herbal Medicinal Products

Annex 8

Sampling of Starting and Packaging Materials

Annex 9

Manufacture of Liquids, Creams and Ointments

Annex 10

Manufacture of Pressurized Metered Dose Aerosol Preparations for Inhalation

Annex 11

Computerized Systems (revision January 2011)

Annex 12

Use of Ionising Radiation in the Manufacture of Medicinal Products

Annex 13

Manufacture of Investigational Medicinal Products

Annex 14

Manufacture of Products derived from Human Blood or Human Plasma (2011년 11월 30일 시행)

Annex 15

Qualification and Validation (2015년 10월 1일 시행)

Annex 16

Certification by a Qualified person and Batch Release (2016년 4월 15일 시행)

Annex 17

Real Time Release Testing and Parametric Release (2018년 12월 26일 시행)


Annex 19

Reference Samples and Retention Samples (December 2005)






Part IV - GMP Requirements for Advanced Therapy Medicinal Products


Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products




Other documents related to GMP


Guidelines on Good Distribution Practice of Medicinal Products for Human Use


Gudelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use


Guidance related to GMP/GDP and PMF distant assessments New


GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances New




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