Validation & Qualification Services

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.

Our Scope of Validation Services

We provide a comprehensive range of validation and qualification services:

• Equipment Qualification (IQ/OQ/PQ): Mixers, dryers, tablet presses, blister lines, autoclaves, depyrogenation tunnels, and vial filling lines.
• HVAC & Cleanroom Validation: Airflow pattern smoke studies, HEPA filter leak testing (DOP method), particle counts, recovery times, and differential pressure mapping.
• Pure Utilities Qualification: Purified water (PW) loops, Water for Injection (WFI) systems, clean steam generators, and process compressed air.
• Computer System Validation (CSV): Validating software systems (PLC, SCADA, LIMS, ERP) in compliance with GAMP 5 and FDA 21 CFR Part 11.
• Thermal Mapping: WHO TRS 961 temperature mapping of cold rooms, warehouses, and incubators.
• Process & Cleaning Validation: Drafting protocol templates, calculated limits, and swab sampling routines.

Our Validation Methodology & Steps

1. Protocol Design: Drafting specific IQ, OQ, or PQ protocols containing test steps, acceptance criteria, and measurement points.
2. Pre-requisite & Calibration Check: Verifying that all test instruments are calibrated and traceable to national standards.
3. Execution: Placing probes, collecting particle data, executing alarm challenges, and recording physical measurements.
4. Data Analysis & Deviations: Analyzing raw data, calculating Mean Kinetic Temperature (MKT), and resolving any deviations.
5. Final Report & Sign-off: Compiling the validation report for review and sign-off by your plant Quality Assurance (QA).

Target Sectors & Audiences

Our validation services serve:

• Sterile product manufacturing facilities (aseptic filling, biological vaccines).
• Solid and liquid oral dosage manufacturers.
• Biotechnology and API development plants.
• Medical device producers.
• Pharmaceutical warehouses and cold-chain logistics centers.

Frequently Asked Questions

• What is the difference between validation and qualification?

  Qualification applies to systems, utilities, and equipment (proving the machine is installed and operates correctly, e.g. IQ/OQ/PQ). Validation applies to processes, analytical methods, cleaning routines, and software (proving the process itself yields quality products consistently).

• Why is Computer System Validation (CSV) critical?

  As factories automate, regulators look closely at data integrity. CSV proves that software systems (such as PLC controllers or BMS databases) record data securely, prevent unauthorized edits, and keep traceable audit trails according to FDA Part 11 rules.