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 addition to the team and we look forward to a long and fruitful career with MIAS.
The pharmaceutical industry is underpinned by a large amount of documentation to show evidence of the quality, safety and efficacy of the drug product throughout it's life cycle. The integrity of records and data can be breached at any time, by any employee – either intentionally or unintentionally. Data integrity failure may involve omissions,
So are you preparing and filing a Marketing Authorisation Application (MAA) in Europe? What needs to be considered and what timelines do you need to work towards? Active Pharmaceutical Ingredients or APIs must be manufactured in compliance with EU GMP and this compliance is confirmed by the QP declaration, which is submitted with the
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, within the EU. The term manufacturing and/or importation includes any of the following manufacturing activities as detailed by the HPRA: processing of a dosage form, primary packaging, secondary packaging, batch certification,
Virtual (or Remote) QP Audits have become a key tool in supplier qualification and health authority inspection programs in the Pharma industry during the pandemic. The regulatory authorities have published guidance on how they will perform their inspections by virtual/ remote audits or distant assessments during this restrictive period. There are several elements to
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 and service providers to obtain written agreements of the details of activities to be provided and the associated requirements and controls. Each agreement type should be tailored to address the
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 industry, NHS and patients. This is not just in terms of our regulatory support to bring new technologies and products quickly and safely to market, but also the personnel and
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 - Communication on readiness at the end of the transition period between the European Union and the United Kingdom". Far-reaching changes and consequences are therefore to be expected after 1
In an ever changing and complex industry the role of the Responsible Person has developed and grown over the past 10 years as the focus of regulatory bodies have placed a higher level of scrutiny on how GDP principals are implemented and applied for Wholesale Distributors. Initially the main areas of compliance for
MIAS Pharma provides QP services for commercial and investigational medicinal products. Our QPs have experience in oversight and release of multiple types of products. Each type of product has it's own specific properties and challenges, which determines what approach should be taken to provide the best solutions. Sterile products have to be free
