ServiceUpdated on 2 April 2024
ZAS GxP Sample Service
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:
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API (Active pharmaceutical ingredient) requiring manufacturing authorization (acc. §13 German Medicinal Products Act)
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Medicinal product (acc. §2 German Medicinal Products Act)
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Investigational medicinal product (§3 German GCP Ordinance)
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Reserve/Retention samples: Active pharmaceutical ingredient (acc. §18 / §27 AMWHV)
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Retention samples: Medicinal Product (acc. Annex 19/§18 AMWHV)
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Reference samples: Medicinal Products (acc. Annex 19)
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Retention samples: Investigational Medicinal Products (acc. Annex 19/§18 AMWHV)
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Reference samples: Investigational Medicinal Products (acc. Annex 19)
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Stability samples API
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Stability samples Medicinal Product
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Stability samples Investigational Medicinal Product
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Analytical samples, test items
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Seed material
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Medical device retention samples
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Samples from industry production
Type
- Others
Applies to
- Manufacturer
- Biotech and Lifescience
Organisation
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Benjamin Bader
Managing Director at ZAS Archive Services for Life Sciences
Neubrandenburg, Germany
Service
- Others
- Manufacturer
- Biotech and Lifescience
Benjamin Bader
Managing Director at ZAS Archive Services for Life Sciences
Neubrandenburg, Germany
Service
- IT
- Others
- Manufacturer
- Biotech and Lifescience
Benjamin Bader
Managing Director at ZAS Archive Services for Life Sciences
Neubrandenburg, Germany