Frequently asked question.
Qualified Persons ensure batch certification compliance by confirming, in line with EU GMP Annex 16, that each batch has been manufactured, tested, and reviewed in accordance with GMP, the Marketing Authorisation, and the approved Pharmaceutical Quality System. Certification is based on documented evidence, effective deviation and change management, data integrity assurance, and risk-based professional judgment focused on patient safety. For imported medicinal products, Annex 21 further requires the QP to verify that manufacturing and testing performed outside the EU are equivalent to EU GMP, that appropriate quality agreements are in place, and that all required controls and verifications have been completed before release to the EU market.
Yes. Our certified RPs manage wholesale distribution compliance, supplier qualification, GDP documentation, transport oversight, and temperature-controlled product flows (2–8°C, –20°C, –70°C).
Absolutely. We offer gap analyses, mock inspections (EU GMP, GDP, FDA, PIC/S), SME coaching, and real-time inspection support including observation-response drafting.
Yes. QP Pro Services (QPPS) provides full support for EU pharmaceutical importation (MIA). We help establish a compliant importation framework in line with EU GMP, Annex 21, and Annex 16, covering batch certification, QP oversight, and quality agreements with third-country manufacturers. Our support also integrates pharmacovigilance, GDP-compliant distribution, and the role of the RiP (Responsible Information Person) to ensure all regulatory, quality, and safety requirements are fully met. With QPPS, importation processes are auditable, robust, and designed for continuity, ensuring that products reach the EU market safely, efficiently, and in full compliance.
Yes, all our trainings are tailor-made. We design programs on Annex 1, Annex 16, CCS, APS/media-fill, QP/RP responsibilities, batch documentation, data integrity, QMS management, inspection behavior, and any EudraLex topic required.
Check others question.
QPs are responsible for reviewing manufacturing processes, quality control data, and product documentation to ensure that batches meet regulatory standards, including EU GMP, Annex 16, Annex 21, and specific product requirements. They also ensure traceability and compliance with all regulations before issuing certification.
Yes. QP Pro Services (QPPS) supports the end-to-end setup of EU pharmaceutical importation, covering not only GMP and batch release, but also the downstream and regulatory interfaces required for full EU compliance. In line with EU GMP Annex 21 and Annex 16, we establish compliant importation and certification processes, including third-country manufacturer qualification, quality agreements, SOPs, and QP release workflows. In parallel, we ensure alignment with pharmacovigilance obligations by defining MAH–QPPV interfaces, escalation pathways, safety data exchange, and release-to-market conditions linked to PV readiness. We also support GDP-compliant distribution models, including warehouse qualification, transport oversight, temperature control, and integration between importation, batch release, and distribution release. The result is a fully integrated, auditable importation ecosystem—from third-country manufacturing to EU market release—designed to ensure compliance, continuity, and regulatory confidence.
Inspection readiness ensures that your processes, documentation, and systems are fully compliant with regulatory requirements. Our team helps you prepare for audits and inspections by conducting mock inspections, reviewing documentation, and coaching your teams to effectively handle inspector interactions. Being inspection-ready mitigates the risk of regulatory observations and helps maintain your market access.
Yes. QP Pro Services (QPPS) provides structured QP/RP back-up and contingency coverage as an integral part of its services. Our model is designed to ensure continuous QP/RP availability in line with EU regulatory expectations, avoiding operational delays, certification bottlenecks, or compliance risks due to absence, overload, or unforeseen events. Back-up QPs are fully qualified, briefed on the client’s quality system, and integrated through defined handover, documentation, and escalation processes. This approach is supported by a network-based model with coaching and mentoring, ensuring that each QP not only covers availability but can take informed ownership, make sound certification decisions, and maintain seamless business continuity.
We offer comprehensive support during inspections, including pre-inspection assessments, gap analysis, and coaching for your team members. Our experts help you handle the entire inspection process—from ensuring correct documentation and practices to managing responses to observations and facilitating smooth communication with inspectors.
Let’s join hands and make it happen with the team!
Success is never a solo journey—it’s a collective effort driven by teamwork,
collaboration, and shared vision. When we come together.