Service Overview
In the pharmaceutical, biotech, and medical device sectors, validation is not optional—it is a core regulatory requirement. Validation is the documented evidence proving that a process, system, or equipment consistently produces an output meeting pre-defined specifications and quality attributes.
QEEMA Egypt is a premier validation provider. We support factories across Egypt with experienced validation engineers, calibrated measurement instruments, and a risk-based approach to compliance. Our services cover the entire validation life-cycle, aligning with the guidelines of the Egyptian Drug Authority (EDA), WHO, EMA, and the US FDA.
Core Scope & Technical Deliverables
Equipment Qualification (IQ/OQ/PQ)
Qualifying tablet presses, autoclaves, depyrogenation tunnels, mixers, dryers, blister lines, and aseptic filling equipment.
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
HVAC & Cleanroom Validation
Airflow pattern smoke studies, HEPA filter integrity testing (DOP method), particle counts, recovery time tests, and pressure differential mapping.
- HEPA filter PAO/DOP leak test
- Airflow pattern smoke video logs
- Particle counts per ISO 14644
Pure Utilities Qualification
Purified Water (PW) loops, Water for Injection (WFI) systems, clean steam generators, and process compressed air qualification.
- PW & WFI sampling protocols
- Clean steam quality testing
- Compressed air dew point & oil check
Thermal Mapping & Process Validation
WHO TRS 961 temperature mapping of cold rooms, warehouses, incubators, plus cleaning and process validation protocol drafting.
- Warehouse & cold room mapping
- Cleaning validation swab limits
- Mean Kinetic Temperature (MKT)
Implementation Methodology
Protocol Design
Drafting specific IQ, OQ, or PQ protocols containing test steps, acceptance criteria, and measurement points.
Pre-requisite & Calibration Check
Verifying that all test instruments are calibrated and traceable to national standards.
Protocol Execution
Placing probes, collecting particle data, executing alarm challenges, and recording physical measurements.
Data Analysis & Deviations
Analyzing raw data, calculating Mean Kinetic Temperature (MKT), and resolving any deviations.
Final Report & Sign-off
Compiling the validation report for review and sign-off by your plant Quality Assurance (QA).
Target Sectors & Applications
Our specialized consulting services cater to: