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Good Manufacturing Practices (GMPs)

Good manufacturing practices (GMPs) lie at the heart of quality. GMPs comprise of a variety of practices that ensure quality including things such as: -

  • raw materials quality assurance
  • record-keeping of substances throughout the manufacturing process
  • standards for cleanliness and safety
  • qualifications of manufacturing personnel
  • in-house testing
  • production and process controls
  • warehousing and distribution
  • Process layout plan and construction

GMP Construction & Plants

SSI Cert specialises in construction activities subject to GMP requirements for food, pharmaceutical and medical devices industries.

Depending on the client's needs, we function as wide-spectrum consultants following the client through the entire project, as building owner consultants, or disciplinary specialists - or we perform the actual engineering activities.

The activities cover the following areas: -

  • Layout plan study to minimize contamination
  • Factory Construction Works
  • Cool room, Freezer room, Clean room
    • Changing room, waste disposal, cleaning and sanitation
    • Exposy flooring, PVC wall paneling, ceiling etc
    • GMP equipments and tools
    • Design & installation of Class 100K & 10K clean room according to ISO14644-1
  • GMP Documentation and implementation: -
    • Developing GMP Standard Operating Procedure (SOP)
    • GMP personal hygiene and personal protective garments, hairnet mask etc
    • Train the company’s personnel to adhere to these GMP SOP
    • Verify the GMP implementation effectiveness by inspection and testing: bioburden, clean room performance validation & maintenance etc
  • Others: -
    • Equipment Qualification
    • Process Validation
    • Cleaning Validation
    • Systems Compliance
    • GMP Audit

Process Plants & Equipment

When you set out to construct complex Pharmaceutical, Food and Medical Devices process plants it is vital to combine understanding of the technical process, GMP knowledge, knowledge of the latest technology and suppliers with a solid design and a solid project management process.

With this solid process knowledge, Prinsip Mahir Sdn Bhd is in a position to cover the entire process right from the initial process design over specification, design, construction, and test to validation of the systems. We also take on total responsibility for delivering the complete plant, sometimes working with partners and subcontractors.

 

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