How can you avoid common GMP equipment and facility risks?

1 Equipment design and qualification

One of the key aspects of avoiding GMP equipment and facility risks is to ensure that the equipment is designed and qualified for its intended use. This means that the equipment must meet the specifications, performance criteria, and operational requirements of the manufacturing process, as well as the applicable GMP standards and regulations. Equipment design and qualification should be based on a risk assessment and a validation plan that cover all the relevant aspects, such as functionality, compatibility, maintenance, cleaning, calibration, and documentation. By doing so, you can prevent equipment failures, malfunctions, and deviations that could affect the product quality and safety.

2 Equipment maintenance and calibration

Another important aspect of avoiding GMP equipment and facility risks is to ensure that the equipment is maintained and calibrated regularly and properly. This means that the equipment must be kept in a good working condition, free from defects, damages, and wear and tear that could impair its performance and reliability. Equipment maintenance and calibration should be performed according to a predefined schedule and procedure that follow the manufacturer's recommendations and the GMP requirements. Maintenance and calibration records should be kept and reviewed to verify the equipment status and functionality. By doing so, you can detect and correct any equipment issues, errors, or deviations that could compromise the product quality and safety.

5 Facility maintenance and cleaning

A fifth vital aspect of avoiding GMP equipment and facility risks is to ensure that the facility is maintained and cleaned regularly and properly. This means that the facility must be kept in a good condition, free from defects, damages, and dirt that could impair its functionality and hygiene. Facility maintenance and cleaning should be performed according to a predefined schedule and procedure that follow the GMP standards and regulations. Maintenance and cleaning records should be kept and reviewed to verify the facility status and cleanliness. By doing so, you can identify and correct any facility problems, errors, or deviations that could compromise the product quality and safety.

6 Facility monitoring and control

A sixth and final aspect of avoiding GMP equipment and facility risks is to ensure that the facility is monitored and controlled continuously and effectively. This means that the facility must have appropriate systems, devices, and indicators to measure and adjust the critical parameters and variables that affect the manufacturing process and the product quality, such as temperature, pressure, humidity, airflow, and contamination. Facility monitoring and control should be performed according to a predefined plan and procedure that follow the GMP requirements and best practices. Monitoring and control records should be kept and reviewed to confirm the facility compliance and performance. By doing so, you can prevent facility deviations, variations, and anomalies that could endanger the product quality and safety.