FEATURED NEWS
GMP/QDP Audits & the Importance of CAPA
The conduct of audits is a key part of our Pharmaceutical Quality Systems to give us information on the activities and standards to which our suppliers and contractors operate.
GMP/GDP Audits & the Importance of CAPA
The conduct of audits is a key part of our Pharmaceutical Quality Systems to give us information on the activities and
Brexit and the Evolving Impact on the Pharmaceutical World
Brexit took place at 11pm on 31 Jan 2020 as the UK departed from the European Union. A transition period of
New QTA requirements with Importation Site
The manufacture of pharmaceutical products for the EU, including active substances and medicinal products, frequently occurs outside of the Union. As
MHRA (GxP) Inspections during COVID19
The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work
Brexit and the Evolving Impact on the Pharmaceutical World
Brexit took place at 11pm on 31 Jan 2020 as the UK departed from the European Union.
New QTA requirements with Importation Site
The manufacture of pharmaceutical products for the EU, including active substances and medicinal products, frequently occurs outside
EMA Reflection Paper on GMP & MAHs – considerations for QPs
In July 2021, the European Medicines Agency (EMA) published the final reflection paper entitled "Good Manufacturing Practice
QP Declarations – Key Considerations
So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines do you need
Top 5 considerations when getting a Manufacturer’s/Importation Authorisation (MIA)
A Manufacturer’s/Importation Authorisation (MIA) is required if a company is involved in manufacturing and/or importation activities relating to human, veterinary or investigational medicinal product,
Best Practice for Virtual Audits
Virtual (or Remote) QP Audits have become a key tool in supplier qualification and health authority inspection programs in the Pharma industry during the