MIA-QP
Qualified Person Batch Release As Per Directive 2001/83/EC
Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the UK or EU require an MIA license and a designated Qualified Person (QP) to oversee the product quality throughout the supply chain.
KeyQP Pharma has Manufacturing and Import Authorization (MIA) licenses based in the UK and Malta under which we can offer our clients to enable batch release within the UK/EU.
- UK MIA(H) 57198 – MIA for Human use
- UK WDA(H) 57198 – WDA for Human use
KeyQP Pharma can provide Contract Qualified Person services (Contract QP) where Qualified Person has obtained QP Qualification under Permanent Provision of 2001/83/EC and are approved on MIA licence by MHRA and other EU Authorities.
Our QPs have experience of Medicinal product Release / certification in the UK/EU in various dosage forms such as,
- Non-sterile (Tablet, Capsules, Creams, Ointments, Oral liquids etc)
- Sterile (lyophilized, liquid or solid in vial / ampules)
- Small molecules (Oral Solid and liquid)
- Biologicals (Mono Clonal antibody, Vaccines)
- Parallel Imported products
Our QP support offering includes:
- Importation activities supported with Batch certification for market release as per the client requirements
- API site QP audits and QP Declaration
- Management of regulatory inspections
- Storage of Quarantine goods at WDA approved warehouse in the UK
- QC testing of batch at UK GMP approved laboratory with certificate of analysis
- Quality Management System review, implementation and improvements
- Implementation of Risk management as per Product Supply chain
- Global auditing of third party manufacturing, QC testing, packaging and labelling facilities as required in support of QP declarations for import into the UK/ EU
- To conduct mock audit for EU GMP readiness and give report for submission to Health Authorities in the UK / EU
