Introduction: MIA for Marketed Products: Importance of matching the correct QP to your product As science advances the types of products on offer have grown in complexity. From Oral Solid Dosage Forms (OSD) to novel Cell and Gene Therapy products, the range of technical knowledge required is vast. At the very end of the manufacturing
MIAS will attend BIO Europe spring 2023 MIAS Pharma will be attending 17th annual BIO-Europe Spring taking place March 20–22, 2023 in Basel, Switzerland. After being delivered digitally over the last two years, the event is expected to bring together over 2,800 executives from biotech, pharma and finance companies to engage in 15,000+
How times flies! It’s almost seven years since the new revision of Annex 16 of the EU GMP Guide: Certification by a Qualified Person and Batch Release, came into effect on 15th April 2016. It was introduced due to the increased complexity of global supply chains as it was felt that the previous guidelines, relating
Last year, the UK Department of Health & Social Care issued a statement emphasizing their continued support for the acceptance of batch testing and certification by a Qualified Person (QP) performed in the EU. This statement came after a public consultation seeking opinions on four potential options for a batch testing policy in the UK
The GMP/GDP Inspectors Working Group has put up and approved a list of frequently asked questions (FAQs) on Good manufacturing practice (GMP) and Good distribution practice (GDP) that the European Medicines Agency (EMA) posts on its website. The list was revised on January 2023. There were three more GDP-related questions added. Maintaining an eye on
When submitting a trial application for a clinical trial in the EU/EEA using an Investigational Medicinal Product (IMP) manufactured in a 3rd country (a country not a member of the EU or EEA), a Qualified Person’s (QP) Declaration is required. This declaration is intended to guarantee that the IMP has been manufactured to standards
In accordance with the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs for human use in accordance with GCP and GMP," investigational medicinal products (IMPs) cannot be used in a clinical trial in a member state of the European Union until the two-step process has been completed. The
Wholesalers must ensure that their suppliers are permitted to supply pharmaceuticals. Legal History The following is applicable in accordance with chapter 5.2 of the EU GDP Guidelines (Guidelines on Good Distribution Practice of Medicinal Products for Human Use, 5 November 2013 - 2013/C 343/01): Only individuals who themselves have a wholesale distribution authorization or who
The European Medicines Agency (EMA) has launched a pilot project to assess the benefits of analyzing raw data from clinical trials by regulatory authorities when evaluating marketing authorization applications (MAAs) for new medicines, as well as post-authorization applications. Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible
The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". The document is based on a mandate for a dialogue of different actors in the value chain of medicines from manufacturing, authorities, non-governmental organisations as well as from research. The aim was to gain a better understanding of
