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QP Batch Release - Lab Services - QbD Group

QP Batch Release

Reliable GMP batch testing and EU batch release

At QbD Group, we provide comprehensive Qualified Person (QP) batch release services, ensuring your medicinal products meet stringent EU regulatory standards. With our integrated service pack for GMP batch testing, validation, and EU import clearance, we help you navigate complex requirements and ensure your products reach the market efficiently and safely.

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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 to ensure the safety, efficacy, and quality of the products before they are released to the market. Key aspects of QP batch release include:

  • GMP batch testing: Conducting tests for both sterile and non-sterile medicinal products.

  • Compliance with Annex 16: Certifying batch release testing according to EU GMP Guidelines.

  • EU import clearance: Handling import responsibilities for non-EU manufacturers.

  • Marketing Authorization Holder (MAH) services: Acting as a formal MAH for companies without an EU legal entity.

Discover why QP batch release is essential
QP Batch Release - Lab Services - QbD Group

Why is QP batch release essential?

QP batch release ensures:

 

  • Regulatory compliance: Meets stringent EMA and EU GMP guidelines, including Annex 16.

  • Product safety: Confirms the quality and safety of medicinal products for human and veterinary use.

  • Market access: Facilitates import and release of products within the European Economic Area (EEA).

  • Clinical trial readiness: Certifies Investigational Medicinal Products (IMPs) for clinical use.

  • Operational assurance: Mitigates risks of non-compliance, ensuring smooth operations.

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How can QbD Group help?

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

GMP batch testing

GMP batch testing

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

QP declarations

QP declarations

Issuing declarations for Investigational Medicinal Products (IMPs) and marketed products.

Retention sample management

Retention sample management

Storing retention and reference samples.

Quality management

Quality management

Auditing the manufacturing supply chain, managing quality agreements, and reviewing batch documentation.

Regulatory services

Regulatory services

Acting as a Marketing Authorization Holder (MAH) and handling EU import clearance.

Ongoing stability studies

Ongoing stability studies

Providing stability testing to ensure long-term product quality.

Deviation and CAPA management

Deviation and CAPA management

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

QP Batch Release - Lab Services - QbD Group (1)

Why partner with QbD Group?

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.

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Ready to streamline your batch release process?

Ensure your medicinal products meet the highest standards of quality and compliance with QbD Group's QP batch release services. Contact us today to discuss your project and learn how we can support your market success.

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