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This draft guidance, When finalized, will Represent the current thinking of the Food and Drug Administration (FDA or Agency) is this topic. It Does not suit les Any rights for Any Person and is not binding on FDA or the public. You can use an alternative approach if it satisfying the requirements of the applicable statutes and règlements.

Since the ICH guideline Q11 Was finalised, worldwide experience with implementation of the recommendations on the development and manufacture of drug substances HAS Given rise to requests for clarification Relating to the selection and justification of starting materials.

This Question and Answer (Q & A) document est Intended to Provide additional clarification and to Promote convergence on the considerations for the selection and justification of starting materials and on the information Provided That shoulds be in permission marketing applications and / or Master Files. The focus of the Q & A document est one chemical entity drug substances.

FDA Q11 Development and Manufacture of Drug Substances Q & A

 

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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