Introduction: What QP certification and batch release really means in the EU

Do you need to understand QP certification and batch release? If you manufacture or import medicinal products in the EU, you have probably heard that no batch can be sold without EUQP certification and batch release. But what does EUQP certification and batch release actually involve, and why does the HPRA spend more than 2 hours checking it during every inspection?

I have seen batches worth €500k stuck in quarantine for months because companies did not understand EUQP certification and batch release. They thought it was just a signature. It is not. According to EU GMP Annex 16, which is the official rulebook for this topic, QP certification and batch release is the legal process that makes a batch of medicine legal to sell in the EU. Without it, your product is not a medicine, it is just quarantined stock.

In this guide, I will break down Annex 16 in plain English, based on EudraLex Volume 4 – Annex 16. I will show you the steps, the responsibilities, and the templates from Appendix I and II.

What is QP certification and batch release?

Let’s start with the legal definition. In the EU, a Qualified Person (QP) is a person who is legally responsible for certifying that each batch of medicinal product was made and checked in compliance with EU GMP and the Marketing Authorisation (MA).

QP certification and batch release is the act where the QP signs a register or document stating: “I have checked everything, this batch is compliant, and it can be released for sale or export.” This certification is defined in Article 51 of Directive 2001/83/EC for human medicines and Article 55 of Directive 2001/82/EC for veterinary medicines.

The key principle from Annex 16 is simple: A batch of medicinal product cannot be released to the market, and cannot leave the control of the manufacturer, until a QP has certified it. This applies to every batch, whether it is made in Dublin, in Germany, or imported from outside the EU. If you want to understand how import is different, read our guide on EU vs non-EU pharma import regulations.

Why does the EU require QP certification and batch release? To ensure patient safety and to have one single person inside the EU who is personally liable under criminal and civil law. The QP puts their licence on the line for every batch.

The 4 pillars of QP certification and batch release under Annex 16

Annex 16 says that before doing QP certification and batch release, the QP must ensure they have completed their routine duties. These are found in section 1.7of Annex 16 and can be summaried into four things:

1. The batch was made under EU GMP

For QP certification and batch release, the QP must confirm that the batch was manufactured in compliance with EU GMP. That means the manufacturing site has a valid MIA, the PQS is followed, and all deviations were handled. The QP must have access to the batch documentation. If you are an importer, you need to prove that the third-country site is EU GMP compliant. See the requirements here: EU GMP requirements for importers.

2. The batch complies with the Marketing Authorisation (MA)

QP certification and batch release is not just about GMP, it is also about the MA. The MA says exactly how the product must be made, what specifications, what starting materials, what process. If your batch was made with a different API supplier than the one approved in the MA, the QP cannot certify it, even if GMP was perfect. The QP must have access to the current approved MA. This is a common reason for QP refusal.

3. All checks and tests were done

For QP certification and batch release, the QP must ensure all necessary checks, including quality control testing, were carried out. That includes in-process controls, environmental monitoring, QC release testing, and for imported products, testing after import if required. Annex 16 section 1.7.3 lists this explicitly. If one QC test is missing or OOS without investigation, QP certification and batch release cannot happen.

4. All deviations and changes were handled

This is where most companies fail QP certification and batch release. If there was a deviation, an OOS, a complaint, or a change, it must be investigated, documented, and approved before certification. The QP must be involved in the deviation process. You cannot tell the QP after you closed the deviation “by the way we had a deviation”. The QP must review and agree. We explained common mistakes here: common compliance mistakes in EU pharma importation.

How QP certification and batch release works when manufacturing is split (partial manufacturing)

Today, almost no product is made in one single site. One site makes bulk, another does primary packing into blisters, another does secondary packing, another does QC testing. How does QP certification and batch release work then?

Annex 16 says each site that carries out partial manufacturing must be covered by a Technical Quality Agreement (Chapter 7 of EU GMP) and must have its own QP who confirms partial manufacturing.

For example: Site A in Germany makes paracetamol 500mg tablets and does bulk packing. Site B in Ireland does primary packaging into blister packs. Site A must provide a confirmation of partial manufacturing as per Appendix I of Annex 16. That confirmation must include: name of product and manufacturing stage, batch number, name and address of site, reference to Technical Quality Agreement, confirmation statement that it was done in full compliance with EU GMP and MA, name of QP, signature, and date. Without this document, Site B’s QP cannot do final QP certification and batch release.

So final QP certification and batch release can only happen when the final QP has received and reviewed all confirmations from all partial manufacturing sites. This chain is what inspectors check during what EU batch release means audits.

Appendix I vs Appendix II – The two templates you must know for QP certification and batch release

These give the exact wording you must use on the Batch cerification documentation.

Appendix I: Confirmation of Partial Manufacturing. This is used when you are NOT the final releaser. You confirm your stage was GMP compliant. The wording must be: “I hereby confirm that the manufacturing stages referred to in the Technical Quality Agreement have been carried out in full compliance with the GMP requirements of the EU and the terms described in the Agreement for ensuring compliance with the requirements of the Marketing Authorisation(s) as provided by [Contract Giver/manufacturer certifying and releasing the batch].”

Appendix II: Content of the Batch Certificate for Medicinal Products. This is the FINAL certificate for QP certification and batch release. It is the document that goes with the batch to the customer. It must include: Name, strength, dosage form and package size identical to finished pack, batch number, destination country, certification statement: “I hereby certify that all the manufacturing stages of this batch of finished product have been carried out in full compliance with the GMP requirements of the EU and [when within the EU] with the requirements of the Marketing Authorisation(s) of the destination country/countries.”, name of QP, signature, date.

If you miss one element, your batch certificate is invalid and your QP certification and batch release is not compliant.

QP certification and batch release for imported products and special cases

Annex 16 has special rules when you do QP certification and batch release for imported products. This connects directly to how to import medicinal products into the EU step-by-step.

When you import medicinal products into the EU from a third country, QP certification and batch release can only take place after physical importation and after any required testing upon import. The QP must also ensure that the importation itself (transport, storage) was GMP compliant. This is Annex 21 + Annex 16 combined.

Annex 16 also covers two special cases for QP certification and batch release:

Two-step batch release: Sometimes a batch is certified in one Member State and then moved to another Member State for final packing or distribution. The first QP does partial certification, the second QP does final QP certification and batch release. Both must be documented and the supply chain must be traceable.

Unexpected deviations: What if you discover a deviation AFTER QP certification and batch release? Annex 16 says you must inform the QP immediately, and the QP must evaluate impact. If patient risk is possible, you must recall. QP certification and batch release does not end responsibility after signature.

You can verify current MA requirements on the official European Medicines Agency (EMA) website.

Final checklist for compliant QP certification and batch release

To have a compliant QP certification and batch release process that will pass HPRA or any EU inspection, remember this checklist directly from Annex 16:

1. Do you have a registered QP with access to all batch documentation and MA?
2. Is your site covered by MIA for certification and batch release?
3. Do you have Technical Quality Agreements with every partial manufacturer, QC lab, and distributor?
4. Do you have a register or equivalent document where the QP certifies each batch before it leaves your control?
5. Do you have Appendix I confirmations for all partial stages?
6. Do you issue Appendix II Batch Certificates for every released batch?
7. Do you have a procedure for handling deviations found after QP certification and batch release?

If you can answer YES to all 7, your QP certification and batch release process is inspection-ready. If one is NO, you have a gap that can cause a major deficiency.

QP certification and batch release is not just a signature. It is the legal heart of EU pharma quality. It protects patients and it protects your company. Get your QP involved early, keep your Technical Agreements up to date, and never release a batch without full documentation.