Utility in Pharma like WFI, RODI, Compressed Air, Nitrogen, Air Handling Units (AHU) and HVAC (Heating, Ventilation and Air Conditioning) systems support the manufacturing process.
Quantitative and qualitative requirements: In order to be deemed satisfactory, utility in pharma must meet a number of qualitative and quantitative requirements. As a result of input from key departments and organisations as well as manufacturing and technical regulations, many systems have varying quality and standard standards. Critical utilities should come first on the list when a validation programme is put in place for utility systems used in pharmaceutical manufacturing. Each utility system utilized by pharmaceutical or biotech companies must be carefully designed, qualified, and monitored to ensure that the final product meets all requirements for pharmaceutical quality.
cGMP and FDA guidelines: Utility system qualification is designed to ensure that utilities in use conform to health and safety regulations, as well as pharmaceutical manufacturing standards and cGMP guidelines.
