This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 6, Manufacture of Medicinal Gases, of the Good Manufacturing Practice (GMP) guide, that is common to the...
This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 15, Qualification and validation, of the Good Manufacturing Practice (GMP) guide, that is common to the Member...
This concept paper proposes to update Annex 3, Manufacture of Radiopharmaceuticals, of the Good Manufacturing Practice (GMP) guide. Annex 3 is common to the Member States of the European Union (EU)/European Economic Area (EEA) as...
The organisations representing stakeholders involved in GMP activities are encouraged to take part in the consultation and to receive all the comments of this consultation from their members, to compile and send the comments via...
The organisations representing stakeholders involved in GMP activities are encouraged to take part in the consultation and to receive all the comments of this consultation from their members, to compile and send the comments via...
The EMA published for consultation that end the 8 July 2025 a Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to ATMPs. This concept paper aims to outline the...
Mexico’s COFEPRIS has issued GMP guidelines (N.B. this webpage can be translated from Spanish). These guidelines aim to facilitate the recognition of international regulations and reduce administrative barriers for the pharmaceutical industry. Under the new guidelines, Mexico...
Mexico’s COFEPRIS has issued GMP guidelines (N.B. this webpage can be translated from Spanish). These guidelines aim to facilitate the recognition of international regulations and reduce administrative barriers for the pharmaceutical industry. Under the new guidelines, Mexico...
The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch uniformity for drug and biological products....
London, United Kingdom, [20th November 2024]: The Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation committed to the advancement of cell and gene therapies has released its Good Manufacturing Practice...
