Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management …
‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how …
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 …
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 – 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 …
To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the …
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, …
Cell therapy tech transfer blog
Despite the no-man’s land between academia and industry is a well-trod area, it is still fraught with pitfalls this is especially the case when it comes to cell therapy tech transfer. While researchers are often …
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 …
Faecal microbiota transplants are quickly gaining popularity around the world. If you have heard of FMT, chances are either you are not particularly squeamish or you have had enough time to digest the concept, pun intended. To put it …
