Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or …
We are proud to say that PharmOut is now a carbon neutral practice, in doing so reaffirming our commitment as a sustainable global consultancy practice. As a means of continuous improvement, this continues to prepare us for the challenges …
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 …
FDA Citation Tracking Tool Updated October 2022
I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 20011 to 2021, the tool dynamically scrapes data from various live websites …
This popular blog has been updated in 2022 with the latest FDA data.
As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a …
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 …
