---
title: "QP Batch Release — Lab Services | QbD Group"
description: "QbD Group provides comprehensive Qualified Person (QP) batch release services, ensuring your medicinal products meet stringent EU regulatory standards."
url: https://qbdgroup.com/en/services/lab-services/qp-release-and-eu-import
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"QP Batch Release — Lab Services | QbD Group\", https://qbdgroup.com/en/services/lab-services/qp-release-and-eu-import"
---

# QP Batch Release

Reliable GMP batch testing and EU batch release

QbD Group provides comprehensive Qualified Person (QP) batch release services, ensuring your medicinal products meet stringent EU regulatory standards.

## What is QP batch release?

QP batch release is a **regulatory requirement within the European Union** for certifying that medicinal products comply with EU Good Manufacturing Practice (GMP) guidelines. It involves rigorous testing and review of manufacturing, packaging, and transport processes.

Key aspects include:
- **GMP batch testing**: Tests for both sterile and non-sterile medicinal products.
- **Compliance with Annex 16**: Certifying batch release per EU GMP Guidelines.
- **EU import clearance**: Handling import responsibilities for non-EU manufacturers.
- **MAH services**: Acting as Marketing Authorization Holder for companies without an EU entity.

## Why is QP batch release essential?

### Regulatory compliance

Meets stringent EMA and EU GMP guidelines, including Annex 16.

### Product safety

Confirms the quality and safety of medicinal products.

### Market access

Facilitates import and release within the European Economic Area.

### Clinical trial readiness

Certifies Investigational Medicinal Products (IMPs) for clinical use.

### Operational assurance

Mitigates risks of non-compliance, ensuring smooth operations.

## How can QbD Group help?

QbD Group offers a full suite of QP batch release services:

### GMP batch testing

Analytical method transfer (AMT), validation (AMV), and testing for clinical or commercial batches.

### QP declarations

Issuing declarations for IMPs and marketed products.

### Retention sample management

Storing retention and reference samples.

### Quality management

Auditing the manufacturing supply chain and reviewing batch documentation.

### Regulatory services

Acting as MAH and handling EU import clearance.

### Ongoing stability studies

Providing stability testing to ensure long-term product quality.

### Deviation and CAPA management

Addressing out-of-specification results, change controls, and corrective actions.

## Our process

End-to-end QP batch release with regulatory expertise.

### 1. Batch review

Reviewing manufacturing, packaging, and transport documentation.

### 2. GMP testing

Conducting analytical testing under GMP conditions.

### 3. QP certification

Qualified Person certifies batch compliance with EU GMP.

### 4. Market release

Facilitating EU import clearance and market release.

Why QbD Group

## Your trusted partner

Partnering with QbD Group for QP batch release provides:

Qualified experts

in-house Qualified Persons with deep regulatory expertise.

Integrated services

comprehensive GMP testing and batch release solutions.

Regulatory support

expertise in navigating EMA Directive 2001/83/EC and EU GMP Annex 16.

Tailored solutions

customized services to meet your specific product and market needs.

Global market access

support for non-EU manufacturers to import and release products in the EEA.

## Let's talk Lab Services

From method validation to stability testing, our lab experts are ready to support your analytical needs.

Contact us

---

Source: https://qbdgroup.com/en/services/lab-services/qp-release-and-eu-import — © QbD Group. Quote freely with attribution and a link back.