Every batch of a medicinal product placed on the EU market must be certified by a Qualified Person (QP) under EU GMP Annex 16. At Inglasia, we provide legal QP batch release services that ensure each of your products meets all regulatory requirements before EU market release.
Our QPs review your manufacturing records, technical documentation, and testing results, confirming full compliance with Marketing Authorisation and EU GMP standards. This is not consultancy, storage, or distribution.
When we certify a batch, we take full regulatory accountability, giving you confidence that your products are compliant and ready for the EU market.
We manage our complete QP release pathway, acting as your trusted EU batch release partner. Our team ensures all documentation is thorough, inspections are fully prepared for, and every step meets Annex 16 requirements.
Partner with us for your QP batch release needs and let us handle certification, compliance, and regulatory oversight, so your medicinal products reach the EU market securely and confidently. Learn more about our EU Import & Batch Release services.
QP batch release is the formal legal certification of a medicinal product batch before it can be placed on the EU market. At Inglasia, our Qualified Persons are fully responsible for confirming that every batch meets all regulatory and quality requirements.
Under EU GMP Annex 16, a Qualified Person must review manufacturing records, testing results, and supply chain documentation to ensure full compliance with the Marketing Authorisation. Our QPs take accountability for this certification, meaning that when we approve a batch, it has passed rigorous regulatory scrutiny and is legally ready for EU market release.
This service is not import licensing, storage, or distribution. It is also not general GMP consultancy—our focus is on legally required batch certification under EU law. By managing the entire QP review and approval pathway, we provide ownership and oversight, ensuring that every step aligns with Annex 16 requirements and EU GMP standards.
When you partner with us for QP batch release, you rely on our expertise, accountability, and structured processes to bring your medicinal products to the EU market confidently and compliantly. We certify, we verify, and we take responsibility.
At Inglasia, we manage the full QP batch release process to ensure that every medicinal product entering the EU market is fully compliant. Our approach is structured, consistent, and legally accountable, giving you confidence that your batches meet regulatory standards.
We begin by reviewing all manufacturing records, test results, and batch documentation. Our team ensures that every detail aligns with your Marketing Authorisation and EU GMP requirements before moving to the next step.
Next, we perform a technical compliance assessment. We verify that manufacturing, testing, and quality control processes meet regulatory expectations. This includes technical compliance checks and verification, ensuring batches are EU importation tested by our Qualified QC Vendors. Any deviations are addressed before certification, ensuring no compliance gaps remain.
Once all documentation and technical checks are complete, our Qualified Persons formally certify the batch under EU GMP Annex 16, confirming that the product is compliant and legally ready for market release.
Finally, the certified batch is released for distribution within the EU. You can rely on our regulatory authority to ensure safe, compliant, and timely access to the European market.
This stepwise approach keeps the process simple, clear, and fully focused on compliance and legal responsibility.
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At Inglasia, our Qualified Persons are personally responsible under EU law for every batch they certify. This legal accountability is not delegated—it is embedded in our processes and forms the foundation of the regulatory assurance we provide to our clients.
We ensure every batch meets EU GMP standards before release. Our QPs review manufacturing documentation, testing results, and supply chain records for each batch to confirm compliance with Marketing Authorisation and Annex 16 requirements. Any gaps or deviations are addressed immediately, so only fully compliant batches are certified for the EU market.
Accountability is reinforced through our structured batch management system. Each step, from document review to certification, is logged and monitored under our internal quality framework, providing traceability, audit readiness, and regulatory confidence.
By partnering with us, every batch of your products entering the EU market carries the assurance of our legal and professional authority. Our commitment to accountability means you can focus on your business while we take responsibility for compliance, certification, and safe market release.
At Inglasia, we operate within a strict EU GMP framework to ensure every batch we certify meets regulatory requirements. EU GMP sets the quality standards for manufacturing, testing, and supply chain management of medicinal products, providing a foundation for safe and compliant EU market release.
Annex 16 defines the responsibilities of the Qualified Person in batch certification. Our QPs review each batch against your Marketing Authorisation and all relevant EU GMP standards. We take full ownership of this certification, ensuring that every product we release has been thoroughly checked, verified, and approved under legal and regulatory obligations.
Our compliance-driven approach ensures that we manage every step of the QP release process, from documentation review to technical assessment and final certification. We provide accountability, traceability, and regulatory assurance, so our clients can trust that their batches are fully compliant before reaching the EU market.
For companies seeking a complete regulatory solution, our EU Import & Batch Release services integrate QP certification within a full MIA-authorised import framework, offering a reliable, legally compliant route to European distribution. We manage the process, we certify the batch, and we take responsibility.
Inglasia delivers a full suite of Qualified Person (QP) batch release services designed to ensure regulatory compliance and smooth EU market access. Each service is structured around EU GMP and Annex 16 standards, providing clients with reliable certification and controlled release.
Our QPs certify batches of finished medicinal products before they are released for commercial distribution within the EU. Each batch undergoes thorough documentation and technical review to confirm compliance with the Marketing Authorisation and GMP requirements. Learn more about our EU Import & Batch Release services.
For clinical trials, QPs certify investigational medicinal products (IMPs) to ensure that clinical batches meet EU regulatory standards. This process guarantees that trial material is compliant, traceable, and ready for use in studies under controlled conditions.
Every batch undergoes a detailed technical assessment before certification. Documentation, test results, and manufacturing records are verified against regulatory standards. Only batches that pass this rigorous review receive formal QP approval.
Through these services, Inglasia manages certification, verification, and approval for every batch. Our internal controls and structured processes ensure compliance, audit readiness, and regulatory confidence. Clients can rely on our service as a single point for EU batch certification, linking seamlessly with our broader EU Import & Batch Release services and ensuring a compliant pathway from production to market.
Our QP batch release services support companies that require certified, compliant entry of their medicinal products into the EU market.
Non-EU Marketing Authorisation Holders (MAHs) rely on our QPs to certify batches manufactured outside the EU before they can be legally released.
Virtual pharmaceutical companies benefit from our structured certification processes, allowing them to operate efficiently without establishing their own EU regulatory infrastructure.
Biotech sponsors scaling from development to commercial supply use our services to ensure every batch meets regulatory standards before market release.
Contract manufacturers (CMOs/CDMOs) leverage our QP services to provide compliant EU distribution for their clients’ products.
Clinical sponsors requiring QP oversight for investigational medicinal products rely on our certification to guarantee compliance with EU GMP and Annex 16.
Each of these clients work with us because we handle the responsibility, verification, and approval of every batch. Our structured processes ensure that batches meet all regulatory requirements, inspections are prepared for, and products are fully compliant for EU market release. By partnering with Inglasia, you gain a reliable and legally responsible pathway for QP certification and batch release.
Inglasia’s Qualified Persons bring extensive experience in EU GMP and Annex 16 compliance, ensuring every batch released meets regulatory standards. Their expertise allows clients to rely on precise, structured certification that aligns with the Marketing Authorisation and EU regulatory requirements.
Our processes are designed to be inspection-ready, with detailed documentation, traceability, and rigorous batch verification. Every step is recorded, audited internally, and aligned with EU expectations, giving clients confidence that their batches can withstand regulatory scrutiny.
Full regulatory accountability is central to our service. Certification is not just a signature; it represents a formal legal responsibility under EU law. Each batch certified by our QPs reflects structured evaluation, technical assessment, and documented approval, minimizing risk and ensuring compliance.
Risk control and batch accountability are embedded in our workflows. Deviations are identified early, issues are addressed before certification, and approvals are only given when standards are fully met.
Many companies choose Inglasia because our QPs are trusted partners in compliance, delivering verification, certification, and batch release under a framework that ensures every medicinal product entering the EU market is legally compliant, fully inspected, and thoroughly validated.
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A Qualified Person is legally responsible for certifying that each batch of a medicinal product complies with EU GMP and the Marketing Authorisation. This involves reviewing manufacturing records, testing results, and supply chain documentation before formally approving the batch for EU market release.
Yes. Under EU pharmaceutical law, every batch of a medicinal product must be certified by a Qualified Person before it can be placed on the EU market. This requirement is defined under EU GMP Annex 16 and cannot be bypassed.
QP certification requires a full set of batch documentation, including manufacturing records, certificates of analysis, quality control results, deviation reports, and supply chain verification. All documentation must align with the approved Marketing Authorisation.
The Qualified Person holds personal legal responsibility for batch certification. This accountability is defined under EU law, meaning the QP must ensure full compliance before releasing any batch to the market.
If a batch does not meet EU GMP or Marketing Authorisation requirements, it cannot be certified or released to the EU market. Any deviations or compliance gaps must be investigated and resolved before the QP can approve the batch.
Inglasia is your EU batch release partner, providing reliable, compliant, and fully certified QP batch release services. Every batch we approve meets EU GMP and Annex 16 standards, ensuring regulatory compliance and inspection readiness.
Whether you are a non-EU MAH, biotech sponsor, contract manufacturer, or clinical trial sponsor, our structured QP services provide verification, certification, and legal accountability for your batches. You can trust that your medicinal products are reviewed thoroughly and released in line with EU regulatory requirements.
Take the next step today
Contact our team to discuss your QP batch release needs or schedule a consultation with our regulatory specialists. Learn how our services integrate seamlessly with our broader EU Import & Batch Release services to provide a complete, compliant pathway to the EU market.
With Inglasia as your partner, your batches are certified, compliant, and ready for EU distribution under the authority of our Qualified Persons.
