• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN

Cases

Cases

We highly value the trust of our customers and have completed more than 5000 GMP projects. gempex customers are companies in the pharmaceutical, biotechnology, chemical, API, medical devices, raw and material package, cosmetic and other industries as well as their suppliers. A selection of references in cooperation with our customers follows.

Typical Cases

    Global Compliance
    • GMP Consultancy
    • GAP Analysis
    • Mock Inspection
    • GMP Training
    • GMP Inspection Support
    • 3rd Party Audit
    New Facilities
    • New Plant C & Q
    • Design Review
    • Processes Validation
    Computerized System
    • IT management System Establishment
    • Computerized System Validation
    • Software Validation
    • IT Infrastructure Platform Qualification
    • Computerized System Compliance Training
    Plant QMS
    • GMP QMS Design
    • GMP QMS Establishment
    • GMP QMS Compliance Review
    Multination MAH/MAA
    • Quality Management System Establishment
    • Production License Application and Inspection
    • Quality System Maintenance

Typical Cases

    Global Compliance
    • GMP Consultancy
    • GAP Analysis
    • Mock Inspection
    • GMP Training
    • GMP Inspection Support
    • 3rd Party Audit
One Innovative Pharmaceutical Company-Shanghai
Target Regulation: US/ EU/ China GMP Product Type: Solid preparation
Service Support:
1. MAH strategy analysis
  • Provide models analysis and suggestion 
  • Provide GMP strategy of new plant
  • Provide organization concept 
  • Support to design QMS
2. Workshop presentation
3. Consultancy service report


One Pharmaceutical Company-Zhejiang
Target Regulation: EU/ China GMP
Product Type: Chemical Drug
Service Support:
1. Technology transfer system establishment
2. Technology transfer consultancy for multiple products
  • Technology transfer strategy
  • Gap analysis consultancy
  • Risk assessment consultancy
3. Process studies/validation protocols review and discussion
    New Facilities
    • New Plant C & Q
    • Design Review
    • Processes Validation
One Innovative Pharmaceutical Company-Shanghai
Target Regulation: US/ EU/ China GMP Product Type: Solid preparation
Service Support:
1. MAH strategy analysis
  • Provide models analysis and suggestion 
  • Provide GMP strategy of new plant
  • Provide organization concept 
  • Support to design QMS
2. Workshop presentation
3. Consultancy service report


One Pharmaceutical Company-Zhejiang
Target Regulation: EU/ China GMP
Product Type: Chemical Drug
Service Support:
1. Technology transfer system establishment
2. Technology transfer consultancy for multiple products
  • Technology transfer strategy
  • Gap analysis consultancy
  • Risk assessment consultancy
3. Process studies/validation protocols review and discussion
    Computerized System
    • IT management System Establishment
    • Computerized System Validation
    • Software Validation
    • IT Infrastructure Platform Qualification
    • Computerized System Compliance Training
One Innovative Pharmaceutical Company-Shanghai
Target Regulation: US/ EU/ China GMP Product Type: Solid preparation
Service Support:
1. MAH strategy analysis
  • Provide models analysis and suggestion 
  • Provide GMP strategy of new plant
  • Provide organization concept 
  • Support to design QMS
2. Workshop presentation
3. Consultancy service report


One Pharmaceutical Company-Zhejiang
Target Regulation: EU/ China GMP
Product Type: Chemical Drug
Service Support:
1. Technology transfer system establishment
2. Technology transfer consultancy for multiple products
  • Technology transfer strategy
  • Gap analysis consultancy
  • Risk assessment consultancy
3. Process studies/validation protocols review and discussion
    Plant QMS
    • GMP QMS Design
    • GMP QMS Establishment
    • GMP QMS Compliance Review
One Innovative Pharmaceutical Company-Shanghai
Target Regulation: US/ EU/ China GMP Product Type: Solid preparation
Service Support:
1. MAH strategy analysis
  • Provide models analysis and suggestion 
  • Provide GMP strategy of new plant
  • Provide organization concept 
  • Support to design QMS
2. Workshop presentation
3. Consultancy service report


One Pharmaceutical Company-Zhejiang
Target Regulation: EU/ China GMP
Product Type: Chemical Drug
Service Support:
1. Technology transfer system establishment
2. Technology transfer consultancy for multiple products
  • Technology transfer strategy
  • Gap analysis consultancy
  • Risk assessment consultancy
3. Process studies/validation protocols review and discussion
    Multination MAH/MAA
    • Quality Management System Establishment
    • Production License Application and Inspection
    • Quality System Maintenance
One Innovative Pharmaceutical Company-Shanghai
Target Regulation: US/ EU/ China GMP Product Type: Solid preparation
Service Support:
1. MAH strategy analysis
  • Provide models analysis and suggestion 
  • Provide GMP strategy of new plant
  • Provide organization concept 
  • Support to design QMS
2. Workshop presentation
3. Consultancy service report


One Pharmaceutical Company-Zhejiang
Target Regulation: EU/ China GMP
Product Type: Chemical Drug
Service Support:
1. Technology transfer system establishment
2. Technology transfer consultancy for multiple products
  • Technology transfer strategy
  • Gap analysis consultancy
  • Risk assessment consultancy
3. Process studies/validation protocols review and discussion

Reference

Evonik Operations GmbH

gempex provided Evonik to qualify suppliers in order to maintain compliance requirements.

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BASF SE

Review and Adaptation of the Zone Concept for Active Substance and Auxiliary Material Filling Areas.

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Medicom Pharma GmbH

QM System Upgrade, Inspection Readiness, Training and long-term GDP Compliance Consulting.

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IBR Inc.

GMP Upgrade for obtaining an official GMP certificate by Swissmedic.

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DR. KADE Pharmazeutische Fabrik

Inspection Readiness for the Production of Pharmaceutical Ointments and Creams – Preparation for Inspection by the Russian Health Authorities (MIT).

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CureVac

Continuous, broad technical support in various projects as GMP expert and project manager in the service fields of qua- lity control, project management, qualification, validation and routine GMP operation.

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b+b

Validation package for serialisation software, IT validation documents for software solutions.

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United Pharma Partners

Inspection readiness and many years of GDP consultancy as lead consultant.

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BrüggemannAlcohol Heilbronn GmbH

Comprehensive GMP Upgrade for obtaining an official GMP certificate.

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Saint-Gobain Performance Plastics Corporation

Plant relocation, new cleaning room, verification and qualification.

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