Utilities:

These are the support systems required for the operation of manufacturing, testing, and storage facilities. Examples include:

HVAC: Controls temperature, humidity, and air quality.

Water Systems: Purified Water (PW), Water for Injection (WFI), and Clean Steam.

​Compressed Air and Gases: Used in manufacturing processes.

​Electrical Systems: Power supply and backup systems.

​Waste Management Systems: For safe disposal of waste materials.

Facilities:

​These are the physical structures where manufacturing, testing, and storage activities take place.  Examples include:   

Cleanrooms: Controlled environments with specific air quality standards.

Warehouses: For storage of raw materials and finished products.

Laboratories: For quality control and testing.

​Production Areas: Where manufacturing processes occur.

Regulatory Compliance: Ensures adherence to global regulatory standards.

Product Quality and Safety: Maintains the integrity and safety of products.

Operational Efficiency: Ensures reliable and efficient operation of utilities and facilities.

Risk Mitigation: Reduces risks associated with failures or contamination.

Audit Readiness: Provides documented evidence for regulatory inspections and audits.