Which type of products are covered by EudraLex Volume 4?
Regulatory Sciences. Medical Device and DiagnosticCell and Gene Therapy.
What is the EU GMP?
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
Which EudraLex volume is are related to good manufacturing practice?
Volume 4
EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.
How many volumes are there in EudraLex?
10 volumes
EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 – Pharmaceutical Legislation.
What is GMP manufacturing?
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
What are the Good Manufacturing Practice GMP guidelines?
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
WHO GMP main principles for pharmaceutical products?
Good manufacturing practices for pharmaceutical products.