GDP (Good Distribution Practice) is essential in Radiopharma Clinical Trials because it ensures that the medicinal products being used are of consistent quality and are delivered to the clinical trial site in a safe and secure manner. GDP guidelines are designed to ensure that all aspects of the clinical trial supply chain, from manufacturing
Radiopharmaceuticals are used in the specialised area of nuclear medicine (clinical imaging and therapy) to diagnose, evaluate and treat diseases. The use of radiopharmaceuticals covers a broad range of procedures such as: diagnosis (single photon emission computed tomography, SPECT; and positron emission tomography, PET) radiation therapy (for oncology and palliative pain management) early research
Annex 1 of the European Union's Good Manufacturing Practice (GMP) guidelines sets out the requirements for the manufacture of sterile medicinal products. To become Annex 1 compliant, a pharma company needs to ensure that its manufacturing processes and facilities meet the standards outlined in the guideline. The following are some of the key requirements
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
Introduction For any organisation that plays a role in the supply of pharmaceutical products such as manufacturing, QC testing, packaging, storage and distribution, an audit is an essential exercise to evaluate the level of compliance to the required GxP standards. All personnel operating or supporting the manufacturing of medicines are required to understand the current
Our CEO Ann McGee will be speaking at the Pharma and Brexit Conference - hosted by PDA Ireland and PDA United Kingdom. The event will focus on the impact, challenges and solutions for the pharmaceutical industry. Register now on Eventbrite: https://lnkd.in/eVxTutkC Date - September 23rd, 2022 Venue - Crowne Plaza Hotel, Dublin Airport Time - 8:00 a.m. -
We are very excited to announce the appointment of Pierre-HenriBaviera as the new CEO for Mias Pharma Limited. As an experienced CEO, Pierre brings significant senior international leadership capabilities in Professional Services and Technology companies. He will be focused on the next phase of growth for MIAS's people and customers in line with our
MIAS Pharma will be attending the following events in the coming months: 35th Annual Congress of the European Association of Nuclear Medicine (EANM), Barcelona, 15th - 19th of October 2022. The EANM’s vision is to optimise and advance science and education in nuclear medicine for the benefit of public health and humanity within the
The new Annex 21, The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, is now in effect. Are you prepared for it's changes? There are a number of key requirements for a Manufacturing Import Authorisation (MIA) holder when
