GxP – Services

At zelhealth GmbH, we offer comprehensive order logistics solutions for our business partners. From storage to distribution, our team ensures efficient and quality-assured processing of your orders to ensure a smooth supply chain. Our verified transportation options with qualified, temperature-controlled vehicles or thermal shipping boxes guarantee compliance with product requirements.

In our GDP-certified warehouses, we provide separate areas with the optimal conditions for order logistics. These areas are demarcated and labeled both physically and by the system in order to counteract any possible mixing. State-of-the-art storage zones at 2 °C - 8 °C and 15 °C - 25 °C are available for medicines and medical products.

Narcotics and medical cannabis are documented, processed and stored securely in accordance with all legal requirements. 

All framework conditions and activities to be carried out are individually developed and defined in a detailed delimitation of responsibilities contract based on your requirements.

As a GMP-certified contract manufacturer, we at zelhealth GmbH offer you the secondary packaging of medicinal products in accordance with your specific requirements and in compliance with all regulatory provisions.

We carry out the labeling of medical devices in accordance with the requirements of the MDR and IVDR.

Our controlled manufacturing zone provides ideal conditions for the processing and repackaging of medicinal products and medical devices. Our regularly trained staff ensure precise processing according to your specifications. Conformity with the requirements is ensured and confirmed with numerous in-process tests and comprehensive quality control of the finished goods. 

We at zelhealth GmbH offer you international procurement services for individual imports according to § 73.3 AMG as well as for investigational medicinal products from third countries. 

Pharmaceuticals from third countries are transported directly to the customs-free warehouse of zelhealth GmbH by a qualified transportation service provider. This means that short-term import to Germany or interim storage with subsequent onward shipment can be guaranteed. Depending on requirements, storage zones at 2 °C - 8 °C and 15 °C - 25 °C are available. Customs clearance is carried out by our specialist department in compliance with all regulations.

We at zelhealth GmbH offer you comprehensive support in complying with quality and safety standards in GxP-relevant topics. Our focus is on the areas of pharmaceutical wholesale and narcotics law.

We are happy to support you in obtaining a wholesale license in accordance with §52a AMG.

We at zelhealth GmbH offer you support with the auditing of your business partners. From the preparation of the audit report to the evaluation of the audit team's action plan, our specially trained team will carry out all activities according to your specifications.

You benefit from our many years of experience in auditing pharmaceutical companies in the European Economic Area.

We would be happy to provide you with an individual offer.

We at zelhealth GmbH offer you a range of training courses. Our basic training courses and specific specialist training courses, including information on regulatory innovations, form the basis for compliance with GxP-relevant requirements in your company. 

Thanks to the many years of experience of our professionally trained trainers, the training courses are designed to be practical and lively. Questions and practical work assignments are used to check and ensure the success of the training. Upon completion of the training, each participant receives a certificate.

All training courses can be held at our locations, online or at your premises.

The following training packages are available, individual training courses are available on request:

1. basic GDP training

Target group: the entire wholesale team (purchasing, sales, quality assurance)

Duration: 3 hours

Contents: 

• Legal basics (AMG, AMHandelsVO, EU-GDP guideline, FMD)
• The quality assurance system (good documentation practice, auditing, archiving)
• Wholesale processes (counterfeit medicines, securPharm, returns, recalls, mock recall, traceability, quality risk management, customer and supplier qualification)
• Personnel (responsible person, training)
• Qualification of rooms, facilities and transportation (temperature mapping and monitoring, pest control, IT validation)
• Hygiene and cleaning (cleaning plan, cleaning routines and documentation)

2. GDP training for the responsible person (according to § 52a AMG)

Target group: the person responsible for wholesale (according to § 52a AMG)

Duration: 2 hours

Content:

• The wholesale authorization (scope of the authorization, ensuring compliance)
• Supplier qualification (requirements for suppliers, due diligence, questionnaires and audits)
• Contract management (delineation of responsibility contracts with suppliers and customers)
• Training (training and review of training success)

3. narcotics training

Target group: the person responsible for narcotics (§6 BtMG)

Duration: 2 hours

Contents: 

• Legal basis (BtMG, BTMBinHV)
• Securing the narcotics
• Documentation (electronic dispensing receipt procedure, records according to §17 BtMG, reports according to §18 BtMG)
• Destruction