• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

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
    • GMP Upgrade
    • Mock Inspection
    • Inspection Support
    • 3rd Party Audit
    • GMP Training
    Facilities Compliance
    • Design Review
    • Commission & Qualification
    • Processes Validation
    Computerized System
    • CS Management System
    • CSV Computerized System Validation
    • Software Validation
    • Infrastructure Platform
    • Data Integrity (DI)
    • CS Compliance Audit
    • CS Compliance Training
    Plant QMS
    • Structure Concept
    • QMS Establishment
    • Compliance Review
    • Operating Monitoring
    • QMS Upgrade
    • Statistics Application
    • Routine quality Consulting
    • CCS Support
    Multination MAH/MAA
    • Market Authorization Strategy Planning
    • MAH/MAA QMS
    • License Application
    • Inspection Support
    • Vendor/Supplier Management
    • Outsourced QA
    • GxP

Typical Cases

    Global Compliance
    • GMP Consultancy
    • GAP Analysis
    • GMP Upgrade
    • Mock Inspection
    • Inspection Support
    • 3rd Party Audit
    • GMP 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
    Facilities Compliance
    • Design Review
    • Commission & Qualification
    • 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
    • CS Management System
    • CSV Computerized System Validation
    • Software Validation
    • Infrastructure Platform
    • Data Integrity (DI)
    • CS Compliance Audit
    • CS 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
    • Structure Concept
    • QMS Establishment
    • Compliance Review
    • Operating Monitoring
    • QMS Upgrade
    • Statistics Application
    • Routine quality Consulting
    • CCS Support
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
    • Market Authorization Strategy Planning
    • MAH/MAA QMS
    • License Application
    • Inspection Support
    • Vendor/Supplier Management
    • Outsourced QA
    • GxP
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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K+S AG

US FDA Inspection Readiness and Inspection Support

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Coperion K-Tron (Schwitzerland) LLC

Individually tailored GMP training for pharmaceutical conveyor equipment manufacturer

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Topwell Apotheke Dr. Kreyenbühl

Improvement of the GMP processes and upkeep of the production license for pharmaceutical products in small quantities

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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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