Pharma Case Studies
Proven compliance and engineering solutions executed across leading pharmaceutical plants in Egypt.
Cleanroom & HVAC Qualification (Aseptic Filling Line)
10th of Ramadan City, Egypt
The Challenge
A prominent manufacturer of sterile injectables needed to qualify their Class A (ISO 5) aseptic filling room and its dedicated HVAC system to comply with the updated EU GMP Annex 1 guidelines. The plant faced strict deadlines for an upcoming regulatory inspection.
Our Solution
QEEMA's validation engineers executed a comprehensive qualification protocol. This included cleanroom air balancing, airborne particle count monitoring, HEPA filter integrity leak tests (DOP method), cleanroom pressure differential tests, recovery time determination, and smoke flow visualization (airflow pattern videos).
The Outcome
The facility successfully demonstrated compliance with EU GMP Annex 1 standards. Complete IQ/OQ/PQ documentation was generated and approved by the regulatory authority on the first audit, permitting immediate commercial sterile manufacturing.
Validation Master Plan & Full Equipment IQ/OQ/PQ
Badr City, Egypt
The Challenge
A newly built solid-dosage pharmaceutical facility required a complete Validation Master Plan (VMP) and qualifications for all production equipment (high-shear mixers, fluid-bed dryers, tableting presses, and blister packaging machines) for their local EDA license inspection.
Our Solution
QEEMA designed a risk-based Validation Master Plan incorporating Quality Risk Management (QRM) principles. We drafted, executed, and archived individual IQ, OQ, and PQ protocols for every machine. We also performed cleaning validation limits calculations based on toxicological PDE data.
The Outcome
The EDA inspection team approved the VMP and validation records without any major or critical deficiencies. The plant received its commercial production license on schedule.
WHO TRS 961 Thermal Mapping of 5,000 sqm Warehouse
Obour City, Egypt
The Challenge
A regional pharmaceutical distributor needed to perform thermal mapping of their 5,000 sqm high-rack warehouse to satisfy Good Distribution Practice (GDP) guidelines and WHO TRS 961 guidelines. They needed mapping for both summer and winter extremes.
Our Solution
QEEMA placed 45 pre-calibrated temperature and relative humidity loggers across three dimensions (bottom, middle, top levels) of the storage racks. The loggers collected data continuously for 7 days. We generated hot and cold spot profiles and calculated the Mean Kinetic Temperature (MKT).
The Outcome
Identified three hot spots near the high skylights and recommended localized ventilation tweaks. The mapping study complied fully with GDP audits, ensuring safe distribution of temperature-sensitive vaccines and biological drugs.