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
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. Date - September 23rd, 2022 Venue - Crowne Plaza Hotel, Dublin Airport Time - 8:00 a.m. - 5:00 p.m. Please see below
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 conduct of audits is a key part of our Pharmaceutical Quality Systems to give us information on the activities and standards to which our suppliers and contractors operate. It is important for us to have confidence in the quality of the materials and products that are manufactured and analysed and in control of
Brexit took place at 11pm on 31 Jan 2020 as the UK departed from the European Union. A transition period of 11 months began on 01 Feb 2020 until 31 Dec 2020. This transition period allowed for the UK to continue to follow EU rules while both sides worked out what the future EU/UK
The manufacture of pharmaceutical products for the EU, including active substances and medicinal products, frequently occurs outside of the Union. As required by the HPRA “A manufacturer’s authorisation (MIA) is needed if a company is involved in any of the following manufacturing activities: processing of a dosage form, primary packaging, secondary packaging, batch certification,
