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