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.