MIAS Pharma has a team of experts that can provide expert Quality and Compliance support services to your organisation from both high-level QA strategic planning and decision making through to the provision of a Virtual Quality Department service across your pharmaceutical product supply chain.
MIAS holds two MIA’s for Commercial and Clinical products and has a Quality Management System in place that has been approved and validated by the HPRA (Ireland’s Regulatory Body). Should your company currently not have your own quality system in place MIAS can provide the facility to add your products to the MIAS QMS.
Virtual Quality Department Services Include:
- Working with your Quality, Operations, Supply Chain and Regulatory teams to map the supply chain, including the quality and regulatory compliance roles and responsibilities of your organisation and of your contractors, vendors and third parties involved in the supply chain
- Developing the Pharmaceutical Management System framework required to manage quality across the supply chain, as per ICH Q10, including the wider responsibilities of the Marketing Authorisation Holder (MAH) such as pharmacovigilance, medical information, promotion and advertising
- Documenting QA procedures (SOPs), elements of the QMS framework, describing quality procedures impacting on the supply chain, and also QA procedures for preventing falsified medicines from entering the supply chain
- Provision of contract QP services in compliance with legislation for the manufacture and release of finished pharmaceuticals and GMP
- Provision of QP services in compliance with legislation for Pharmacovigilance
- Provision of contract RP services in compliance with legislation for the wholesaling of medicinal products and GDP
- Provision of contract Virtual QA services by:
- acting as your company’s Quality Operations contract service provider in Europe
- assessing and qualifying your contractors, vendors and third parties through auditing, using the principles for Risk Management as per ICH Q9
- periodic reassessment of your contractors and vendors as per your vendor management programme
- preparing your Quality/Technical Agreements with your contractors, vendors and third parties, to include assigning roles and responsibilities for Quality Assurance to both parties
- monitoring QA metrics reported for your contractors, vendors and third parties and presenting to your Quality and Supply Chain function
- managing your self-inspection programme