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.
Final Annex 21 to Come into Effect August 21st 2022
The final version of Annex 21 to the EU-GMP Guidelines ("Importation of medicinal products") has been published in EudraLex Vol. 4. The draft
BREXIT – Impact, Challenges and Solutions for the Pharmaceutical Industry
Our CEO Ann McGee will be speaking at the Pharma and Brexit Conference - hosted by PDA Ireland and PDA United Kingdom. The event will
The Commenting Process for new GDP-relevant Documents from FDA and USP has been extended.
FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has
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 – Impact, Challenges and Solutions for the Pharmaceutical Industry
Our CEO Ann McGee will be speaking at the Pharma and Brexit Conference - hosted by PDA Ireland and PDA United
The Commenting Process for new GDP-relevant Documents from FDA and USP has been extended.
FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February
GMP/GDP Audits & the Importance of CAPA
The conduct of audits is a key part of our Pharmaceutical Quality Systems to give us information
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 the continued success
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 a very welcome
Good Practices for Data Management and Integrity
The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of the drug product