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e-newsletter

 

 

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

 


EMA Quality Guidelines (Chemical & Herbal)

 

 

 

 

Active Substance

1

Guideline on the Chemistry of New Active Substances New

2

Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier

3

Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances

 

 

 

 

Manufacture of the medicinal products

1

Guideline on Process Validation for Finished Products - information and data to be provided in regulatory submissions

2

Guideline on Manufacture of the Finished Dosage Form

3

Annex: Start of Shelf-Life of the Finished Dosage Form

 

 

 

 

Specifications, analytical procedures and analytical validation

1

Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)

2

Use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations

 

 

 

 

Excipients

1

Quality of Water for Pharmaceutical Use

2

Reflection Paper on Water for Injection Prepared by Reverse Osmosis

3

Guideline on Excipients in the Dossier for Application for Marketing Authorization of a Medicinal Product

 

 

 

 

Packaging

1

Plastic Primary Packaging Materials

 

Stability

1

In-Use Stability Testing of Human Medicinal Products

2

Maximum Shelf-Life for Sterile Products for Human Use After First Opening or Following Reconstitution

3

Stability Testing for Applications for Variations to a Marketing Authorisation

 

 

Biologicals

1

Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products

2

Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

 

 

 


 

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