HVAC Validation in Pharma HVAC Validation = Control + Evidence + Compliance 1. DQ – Design QualificationVerify HVAC design meets GMP, process, room classification & user requirements. 2. IQ – Installation QualificationConfirm equipment, ducts, filters, sensors, controls and utilities are installed as per approved specifications. 3. OQ – Operational QualificationChallenge and verify HVAC operation under … Read more
AHU / CLEANROOM REQUALIFICATION Reference: ISO 14644-3:2019 + ISO 14644-2:2015 Objective: To verify that the AHU/cleanroom continues to maintain the required air cleanliness and environmental conditions during operation. ISO 14644-3 provides the applicable cleanroom test methods, while ISO 14644-2 establishes the monitoring/periodic-testing framework. KEY REQUALIFICATION TESTS Airflow Volume / Velocity→ Verify supply airflow and required … Read more
Utilities in the Pharmaceutical Industry Utilities are the essential support systems that enable pharmaceutical manufacturing, testing, packaging, and storage operations. Although utilities are not always part of the finished product, they directly impact product quality, patient safety, process reliability, and regulatory compliance. Therefore, pharmaceutical utilities must be designed, qualified, operated, monitored, maintained, and periodically reviewed … Read more
Questions & Answers Utilities, Water Systems, Steam, Gases, and Heating/Cooling Systems EUGMP- Annex-1 Question 1. The level of controls applied to utility systems should be based on: A. Historical dataB. Auditor preferenceC. Risk to product qualityD. Cost of maintenance ANSWER – C Question 2. Utility system impact must be assessed and documented as part of the: A. Preventive … Read more
CHECKLIST FOR PREVENTIVE MAINTENANCE OF COMPRESSION MACHINE Equipment code: ___________________________ Frequency: Quarterly Open and clean the panel internally and externally using vacuum cleaner/air blower. Visually check the tightness of cable termination at MCCB incoming and outgoing side and at outgoing MCB. Check the operation and setting of all machine interlocking. Check all terminations for overheating. … Read more