Good engineering practice of updating standards
It is involved in: In addition Directive 2001/83/EC and Directive 2001/82/EC lay down related provisions.
The EU GMP guidelines provide interpretation of these principles and guidelines, supplemented by a series of annexes that modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic.
The Principal Supply Chain Partners have developed a number of repeatable room arrangements for use in NHS Acute and Mental Health facilities, all of which are fully complaint with HBNs and HTMs.
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After inspecting a manufacturing site, EU competent authorities issue a GMP certificate or a non-compliance statement, which is entered in the Eudra GMDP database.
EMA chairs and provides the secretariat for the GMP/GDP Inspectors Working Group of senior inspectors appointed by all the EEA competent authorities. The European Commission and observers from EU accession coutnries, mutual recognition partner authorities, the European Directorate for the Quality of Medicines and Health Care and the World Health Organization also attend the working group's meetings.
Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned.
If an MRA applies, the authorities mutually rely on each other's inspections.
EMA facilitates cooperation between the authorities concerned in supervising the site.GMP requires that medicines: The Agency has a coordinating role for GMP inspections of manufacturing sites for medicines whose marketing authorsation in the EU is submitted through the centralised procedure or as part of a referral procedure.The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level.In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.Importers of active substances intended for the EU market are also required to register.