FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and
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
We’re pleased to announce that MIAS Pharma Ltd has been shortlisted for Pharma Supplier of the Year in this years Pharma Industry awards. We look forward to a great evening and catching up with our peers and suppliers.Since launching in 2014, the Pharma Industry Awards has established itself as the benchmark for those demonstrating excellence in the pharma
The wholesale distribution of medicinal products and active substances is an important activity. The quality and the integrity of medicinal products can be affected by a lack of adequate control. The quality, safety and efficacy of medicinal products depend on a whole range of different factors. The most important factors are that
Last week, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) released their “Safe Importation Action Plan”. The action plan would allow importation of certain prescription drugs from Canada and other countries. Importing drugs, whether from Canada or elsewhere in the world, poses a big
Last week, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) released their “Safe Importation Action Plan”. The action plan would allow importation of certain prescription drugs from Canada and other countries. Importing drugs, whether from Canada or elsewhere in the world, poses a big
A question that gets frequently asked is what GMP-compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products / APIs. The short answer is: the system must be qualifiable. Since this require some clarification, here
