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

•	Introduction

Part I - Basic Requirements for Medicinal Products
Chapter 1	Pharmaceutical Quality System (2013. 1. 31.)
	Pharmaceutical Quality System (draft) (2025. 9.) New
Chapter 2	Personnel (2014. 2. 16.)
Chapter 3	Premises and Equipment (2015. 3. 1.)
Chapter 4	Documentation (2011. 1.)
	Documentation (draft) (2025. 7.) New
Chapter 5	Production (2015. 3. 1.)
Chapter 6	Quality Control (2014. 10. 1.)
Chapter 7	Outsourced Activities (2013. 1. 31.)
Chapter 8	Complaints, Quality Defects and Product Recalls (2015. 3. 1.)
Chapter 9	Self Inspection

Part II - Basic Requirements for Active Substances used as Starting Materials
•	Basic Requirements for Active Substances used as Starting Materials (2014. 9. 1.)

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
•	Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice
•	Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

Annexes
Annex 1	Manufacture of Sterile Medicinal Products (2022.8.22)
Annex 2	Manufacture of Biological Medicinal Products for Human Use (2018. 6. 26.)
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 (2011. 1.)
	Computerized Systems (draft) (2025. 7.) New
Annex 12	Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 13	Manufacture of Investigational Medicinal Products
	Detailed Commission guideline on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014
Annex 14	Manufacture of Products derived from Human Blood or Human Plasma (2011. 11. 30.)
Annex 15	Qualification and Validation (2015. 10. 1.)
Annex 16	Certification by a Qualified person and Batch Release (2016. 4. 15.)
Annex 17	Real Time Release Testing and Parametric Release (2018. 12. 26.)

Annex 19	Reference Samples and Retention Samples (2005. 12.)

Annex 21	Importation of Medicinal Products (2022. 8. 21.)
Annex 22	Artificial Intelligence (draft) New

•	Glossary

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