How the Production Area Should Be Designed Under GMP

How the Production Area Should Be Designed Under GMP

Our engineers at Sistem Patent Kalite support GMP (Good Manufacturing Practice) production area reviews. Under GMP, the production area is designed around the materials handled and the production units present: raw materials and finished products are segregated, and a reject area is established for non-conforming products. Where production allows, these areas are physically separated and made independent. A core GMP principle is flexibility: the producer designs the production area around the product and the process, within HACCP principles and the applicable legal requirements. The design must prevent cross-contamination with hazardous materials.

The production area is laid out to match the production process, so successive process steps follow a logical flow. Hygiene conditions must be a design input, not an afterthought.

• Incoming materials are stored at the appropriate temperature.
• The finished product area is suited to dispatch and product handling conditions, and those conditions are monitored.
• Floors in the production area are non-slip and easy to clean.
• Walls and floors are free of cracks and breaks.
• External water and piping systems are painted and free of rust.
• Drains are covered, either closed or grated.
• The ventilation system (warm, cold, and general) is designed for the product in production.
• Entrances are equipped with air curtains or equivalent controls to keep dust out of production areas.
• A dedicated packaging area is designated, and the packaging material storage is identified.
• Storage conditions are defined for each product family.

How Sistem Patent Kalite Helps

We run production area reviews against the GMP requirements, produce a gap list, and work with your engineering team to close the gaps before the certification audit. Contact us for a scoped quote.