The quality and safety of the production environment in the pharmaceutical GMP workshop is of paramount importance. In order to ensure the quality and safety of pharmaceutical products, companies must design and decorate their workshops in accordance with GMP (Good Manufacturing Practice).
1. Design principles.
1.Functionality: The workshop design should meet the requirements of the production process and process, and the reasonable layout of each area should ensure the smoothness and efficiency of the production process.
2.Safety: The design should comply with safety specifications to ensure employee safety and product quality safety. Safety facilities such as fire prevention and pollution prevention should be complete.
3.Cleanability: The workshop should be easy to clean and maintain, prevent the breeding of microorganisms and dust, and ensure the cleanliness of the production environment.
4.Traceability: The design should enable traceability in the production process to facilitate traceability of product quality and the source of problems.
5.Compliance: The design should comply with national laws and regulations and GMP standards to ensure the smooth passage of the compliance and certification of the workshop.
2. Regional division.
1.Clean area: The area used for the production and packaging of pharmaceuticals should have the highest level of cleanliness and strictly control the entry and exit of people and goods.
2.Auxiliary area: used for auxiliary functions in the workshop, such as equipment maintenance, material storage, etc. Cleanliness requirements can be appropriately reduced in this area.
3.Non-clean area: used for auxiliary functions outside the workshop, such as warehouses, employee lounges, etc. This area does not need to meet cleanliness requirements.
Third, the main points of decoration.
1.Wall: The wall is decorated with sterile, dust-free, moisture-proof and fireproof materials, and the color is mainly light and elegant to avoid reflection and glare causing discomfort to employees.
2.Ground: The ground should be made of non-slip, wear-resistant, and easy-to-clean materials, and the color should be mainly dark to enhance the durability and anti-pollution ability of the ground.
3.Top surface: The top surface should be made of dustproof and fireproof materials, and it is not appropriate to set up a ceiling or only a simple ceiling. Lamps and lanterns should be made of high-efficiency, clean and energy-saving lamps to avoid direct sunlight entering the workshop.
4.Doors and windows: Doors and windows should be made of materials with good sealing and not easy to deform to avoid external pollution entering the workshop. The window sill should be provided with an easy-to-clean slope to prevent dust accumulation.
Fourth, air purification system.
1.The air purification system is an important part of the pharmaceutical GMP workshop, which should meet the cleanliness and humidity requirements required for production.
2.According to the process requirements and cleanliness level of the workshop, the model and configuration of air purification equipment are reasonably selected to ensure that the air quality meets the standard.
3.Regularly maintain and maintain the air purification equipment to ensure the stability and reliability of the equipment.
5. Personnel management.
1.Formulate a strict personnel entry and exit management system to control the flow of personnel and avoid external pollution from being brought into the workshop.
2.Before entering the workshop, employees should carry out strict procedures such as dressing, hand washing, and air shower to ensure that the cleanliness of employees' bodies and clothes meets the requirements.
3.Regularly conduct GMP knowledge and safety training for employees to improve their quality awareness and safety awareness.
6. Material management.
1.Formulate a strict material entry and exit management system to ensure that the quality of materials meets the requirements and prevent contamination and cross-contamination.
2.Materials should be classified and stored according to varieties, specifications, batches, etc., with clear identification for easy traceability and management.
3.Strengthen the cleaning and disinfection of materials to ensure the hygienic quality of materials during storage and use.