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GMP & Cleanroom Construction

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GMP & Cleanroom Construction

GMP

Good manufacturing practices (GMPs) matter a lot as far as quality is concerned. GMPs practices include: –

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

GMP CONSTRUCTION & PLANTS

We at SMC specialize in construction activities subject to GMP requirements for food, pharmaceutical and medical devices industries.

The areas covered are: –

  • 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.