GMPs

Annex-2B-Biologicals

Annex 2B – Manufacture of Biologicals under GMP PE009-015

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update splits Annex 2 into Annex 2A: Advanced Therapy Medicinal Products and Annex 2B: Biological Medicines separately:

Annex 2A: Manufacture …

annex-2a-manufacture-of-atmps-pics

Annex 2A – Manufacture of ATMPs under GMP PE009-015

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update separates Annex 2 into advanced therapy medicinal products (ATMP) and biological medicines, as follows:

Annex 2A: Manufacture of …

EudraLex Volume 4 Annexes - Annex 21

EudraLex Volume 4: EU Annex 21 GMP guidelines

EudraLex, Volume 4 – Good Manufacturing Guidelines
European Union: EU GMP Guide Updates – EU Annex 21 (News)

Manufacturers/Importers and Sponsors who import medicinal products into the EU/EEA must now comply with EU Annex 21 GMP requirements.

Background to EU Annex 21 …

why-eLearning-GMP-business-case-study1

Why eLearning Solves the Manufacturing Training Dilemma.

Why eLearning should be part of your regulatory compliance training programs — including during a pandemic.
The GMP eLearning Business Case
When we consider why eLearning is a valuable addition to GMP training programs, the following concepts come to mind: accessibility, …

GMP-documentation

Australian Regulatory Framework Psychedelic Therapies

Glancing at headlines these days there appears to be a consistent stream of positive news breaking out all over the world about the potential therapeutic benefits of psychedelics, including a declaration from the FDA that psilocybin is a “breakthrough …