Qualified Person for Good Manufacturing Practices
We demonstrate our commitment to quality by consistently requiring strict QA oversight. Our experienced QPs take personal and legal responsibility for batch certification and release — helping you meet the complex regulatory demands of the EU and UK.
QP services for EU & UK markets
Our experienced QPs will help you streamline your product in its journey from clinical trial to market release — giving you confidence that your drug product has been processed and released in compliance with GMP regulations.
We act as QP for MIA holders under TQA with a dedicated job description and well-trained to the specific requirements set out in the QMS. We support both EU and UK drug product release and batch certification.
Our QPs are able to accept personal and legal responsibility, as defined by European and UK legislation, that the medicinal products entering the EU and UK market have been processed following GMP principles and manufactured in accordance with their Marketing Authorisation.
Talk to our QP teamQP responsibilities
- Batch certification & release (IMP & commercial)
- Personal & legal responsibility for GMP compliance
- Clinical trial IMP certification
- EU & UK market release
- Compliance with Marketing Authorisation
QA services for Good Manufacturing Practices
Beyond QP services, we act as the Quality Assurance Department on behalf of several licence holders — ensuring document control, quality review and full GMP compliance.
QMS Development
Cloud-based or paper-based SOPs adapted to local requirements. All SOPs are dedicated to each client — no off-the-shelf systems. GMP, GDP, Medical Device (ISO13485) and Cosmetic.
CAPA & Change Control
Established and proven systems for Corrective Action and Preventative Action (CAPA) and Change Control — adaptable for any situation and compliant with current GMP requirements.
GMP Audits & Gap Analysis
Risk-based SOP audit programme, GMP compliance gap analysis, inspection preparation, Falsified Medicines Directive (FMD) compliance and supply chain expertise.
Quality Review Meetings
Regular Quality Review Meetings with Key Performance Indicators to ensure full oversight of the QMS by all relevant parties — licence holders, service providers and quality department.
Training Programmes
Range of training methods covering new starters, minor amendments, major revisions and periodic review — ensuring continuous GMP compliance across your organisation.
Ongoing Compliance Solutions
Practical ongoing compliance solutions including Falsified Medicines Directive compliance, medicinal product supply chain and transportation expertise — adapted to your work environment.
Need a Qualified Person for your products?
Our QP team is ready to support batch certification, GMP compliance and quality assurance for your EU and UK operations.