ServiceUpdated on 2 April 2024

ZAS GxP Sample Service

Benjamin Bader

Managing Director at ZAS Archive Services for Life Sciences

Neubrandenburg, Germany

About

We provide a seamless end-to-end service that spans the entire retention sample lifecycle. This includes transportation, administration, secure archiving, customized access, easy and fast retrieval, or destruction – all managed with a centralized chain of custody under our control.

By taking advantage of this unique opportunity, our clients can streamline operations, save resources by eliminating in-house storage efforts or enjoy competitive pricing, and benefit from a single-vendor solution with clear legal oversight.

As the only archive with a unique certification coverage including GMP/cGMP and Manufacturing Authorization §13 AMG, our clients can confirm compliance, rely on standardized high quality, and enjoy peace of mind for audits.

Our GLP and GMP-certified security archives are housed in specially protected, climate-controlled facilities. This guarantees the highest level of sample integrity and safety while maintaining agreed storage conditions from handover.

ZAS is a member of the Rhenus Group, one of the leading logistics companies worldwide, supported by a solid infrastructure, operational excellence, and a proven track record of 30 operational years.

We are equipped to store batches of all sizes under compliant and safe conditions in climate-controlled storages:

  • API (Active pharmaceutical ingredient) requiring manufacturing authorization (acc. §13 German Medicinal Products Act)

  • Medicinal product (acc. §2 German Medicinal Products Act)

  • Investigational medicinal product (§3 German GCP Ordinance)

  • Reserve/Retention samples: Active pharmaceutical ingredient (acc. §18 / §27 AMWHV)

  • Retention samples: Medicinal Product (acc. Annex 19/§18 AMWHV)

  • Reference samples: Medicinal Products (acc. Annex 19)

  • Retention samples: Investigational Medicinal Products (acc. Annex 19/§18 AMWHV)

  • Reference samples: Investigational Medicinal Products (acc. Annex 19)

  • Stability samples API

  • Stability samples Medicinal Product

  • Stability samples Investigational Medicinal Product

  • Analytical samples, test items

  • Seed material 

  • Medical device retention samples

  • Samples from industry production

Type

  • Others

Applies to

  • Manufacturer
  • Biotech and Lifescience

Organisation

Z.A.S. Zentral Archiv Service GmbH

Company

Neubrandenburg, Germany

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