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

 


EMA Quality Guidelines

       

Post-Authorisation (Lifecycle Management)

1.

EU variations guidelines - Guidelines on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

 

 

 

 

Active Substance

1.

Guideline on the Chemistry of New Active Substances

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

4.

Quality Working Party questions and answers on API mix

 

 

 

 

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

4.

Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container

 

 

 

 

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.

Guideline on the Quality of Water for Pharmaceutical Use New

2.

Questions and Answers on Production of Water for Injections by Non-distillation Methods - Reverse Osmosis and Biofilms and Control Strategies

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.

Guideline on 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

 

 

Multidisciplinary: cell therapy and tissue engineering

1.

Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP)

 

 

Scientific guidelines

1.

Guideline on quality documentation for medicinal products when used with a medical device  New

   

 


 

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