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 batch certification and release.
Our QPs are able to accept personal and legal responsibility, as defined by European and UK legislation, to process the medicinal products entering the EU and UK market following GMP principles and manufactured in accordance with their Marketing Authorisation.
Do any of these questions apply to you?
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Do you need a Qualified Person for batch certification and release of your medicinal drugs in the EU?
Yes, our accredited Qualified Persons take personal and legal responsibility for batch certification and release of both investigational and commercial medicinal products for human and veterinary use in the EU.
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Are you preparing for a GMP inspection by the authorities?
We prepare your site and your quality system for GMP inspections, from gap analysis to mock inspections and CAPA follow-up afterwards.
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Would you like an independent audit of a manufacturer or supplier?
Our QPs perform independent GMP audits of manufacturers, laboratories and suppliers, and deliver a clear audit report with findings and practical recommendations.
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Do you need help setting up or improving your quality system?
We set up and improve pharmaceutical quality systems, including QMS development and CAPA systems, sized to your organisation and your product portfolio.
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Are you importing medicinal products into the EU and need QP certification?
Medicinal products imported into the EU must be certified by a Qualified Person before release, and we provide exactly that certification for the MIA holder. M.P.C.A. International supports importers with EU and UK GMP compliance.
If you answered yes to any of these, our QP and GMP specialists can help.
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 your licence holders, ensuring document control, quality review and full GMP compliance.
QMS Development
Cloud- or paper-based SOPs adapted to local requirements. All SOPs are dedicated to each client. No off-the-shelf systems. GMP, GDP, Medical Devices (ISO13485) and Cosmetics.
Change Control & Deviations & CAPA
Established and proven systems for Deviations and Change Control implementing Corrective Action and Preventative Action (CAPA). Adaptable for any situation and compliant with current GMP requirements.
GMP Audits & Gap Analysis
Risk-based SOP audit program, GMP compliance gap analysis, audit and 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.
Qualified Person & GMP
Who can act as a Qualified Person (QP) in Belgium?
What does QP batch release involve?
What is GMP and how do you support compliance?
Do you provide QP services for investigational medicinal products?
How can I request a Qualified Person?
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.