FEATURED NEWS
Annex 21 to Come into Effect on August 21st 2022.
The effective date of the new Annex is 21 Aug 2022 – 5 business days from now. Are you ready? There are a number of key requirements for a Manufacturing Import Authorisation (MIA) holder when importing medicinal products (human, IMP, veterinary) from outside the EU/EEA. While none of these are new requirements, there you may need to take action relating to your Quality System controls and records.
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 and the Marketing Authorisation
Merry Christmas and Happy New Year
MIAS has continued exceptional growth and development over 2021. We'd like to thank our Team, Customers and Suppliers for contributing to
Welcome to the Team
We would like to welcome Ciara Kearney, Lisa Evans, Sherry A Calimlim and Olivia McEvoy to the MIAS Pharma Team. They are
Complying with new GDP requirements
In an ever changing and complex industry the role of the Responsible Person has developed and grown over the past 10 years
Merry Christmas and Happy New Year
MIAS has continued exceptional growth and development over 2021. We'd like to thank our Team, Customers and
Welcome to the Team
We would like to welcome Ciara Kearney, Lisa Evans, Sherry A Calimlim and Olivia McEvoy to the MIAS
Good Practices for Data Management and Integrity
The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality,
QTA – Best Practice Design
Quality Technical Agreements (QTAs) are not just a nice-to-have; there is a regulatory requirement to have them established! QTAs are established with manufacturers, suppliers
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 on
Regulations for Pharmaceuticals Post Brexit
The European Commission has published a Communication to prepare for the end of the transition period. The document is appropriately entitled "Getting ready for changes