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ISO 9001
ISO 14001
ISO 45001
ISO 22000
ISO 13485
ISO 17025
TS 16949
GDPMD
GMP-HACCP
HALAL
GMP
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Good Manufacturing Practices (GMPs) Factory Construction and Renovation

 

Factory GMP focus on good processing environment to support a hygienic production to produce safe and quality products. ISO Specialist ™ is specializes in construction activities subject to GMP requirements for food, pharmaceutical and medical devices industries.

Depending on the client's needs, our GMP Consultant will following the client through the entire project as a building owner consultant, or disciplinary specialists from designing stage until the completion of the project to ensure your factory’s GMP is meeting the ISO/Halal certification standards.

Our GMP activities may cover the following areas: -

  • Layout plan design to maintain factory hygiene and minimize cross contamination
    • Analyze human flow, material and product flow, processing flow etc.
    • Provide advice on changing room, waste disposal, cleaning and sanitation requirements.
    • Evaluate suitable construction material for the intended used eg. exposy flooring, PVC wall paneling, lighting, ceiling etc.
    • GMP equipment and tools
  • Supervise factory construction works
  • Compilation of GMP Documentation and supervise implementation: -
    • Developing GMP Standard Operating Procedure (SOP).
    • Implement GMP personal hygiene on personal protective garments, hairnet, face mask etc.
    • Train the company’s personnel to adhere to these GMP SOP
    • Verify the GMP implementation effectiveness
  • Others: -
    • Equipment Qualification
    • Process Validation
    • Cleaning Validation
    • Systems Compliance
    • GMP Audit

Why ISO SpecialistTM?

When you set out to construct complex Pharmaceutical, Food and Medical Devices Plants, it is vital to combine understanding of the technical process with GMP/HACCP/Medical Devices/Halal hygiene and process flow knowledge to achieve certification conformance.

With this solid process knowledge, ISO SpecialistTM is in a position to cover the entire project right from the initial process of designing, if required to monitor construction until completion with the aim to make sure it meets the certification requirements. We also take on total responsibility for delivering the complete package in the project management, sometimes working with partners and subcontractors.

 

   
 
   
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