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21 July 2006

EMEA:
Question and Answer Document on GMP matters

A number of answers to frequently asked questions on GMP and related matters have been added to the website.

Q1- Is it possible to use multiple Batch Numbers in Packaging of Medicinal Products?

Q2- When a new application is submitted in the EEA and a GMP inspection is deemed necessary, which competent authority carries out the inspection?

Q3 - What is a certificate of Good Manufacturing Practice (GMP certificate) and what is the difference between GMP certificates, certificates of medicinal product (also called certificates of pharmaceutical products, CMP or CPP), and Certificates of suitability to the monographs of the European Pharmacopoeia (CEP)?

Q4 - Does EMEA perform GMP inspections?

Q5 - Does EMEA issue GMP certificates?

Q6 - In case a site in a third country has plans to export products to the EEA, is it possible to apply for a GMP inspection on a voluntary basis?

Q7 - Is it possible to ask for a voluntary inspection of an active substance manufacturer?

Q8 - How can GMP compliance for active substance manufacturers be demonstrated?

Q9 - Are active substances used as starting materials in the production of investigational medicinal products (IMPs) subject to GMP?

Q10 - What are the differences between EU and WHO requirements for GMP?

Read the answers to these questions

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