Service Overview
Building a new pharmaceutical facility or expanding an existing sterile filling line is a highly specialized project. General construction companies lack the detailed understanding of Good Manufacturing Practice (GMP) regulations. Mistakes in zoning, pressure differences, airlock positions, or material flow configurations can lead to failed regulatory inspections and extremely expensive renovations.
At QEEMA Egypt, we provide specialized Pharma Startup Projects and Engineering Consulting. We partner with you from day one, taking your project from conceptual layouts to successful licensing by the Egyptian Drug Authority (EDA) or international regulatory bodies. We ensure that GMP compliance is designed into the facility's foundation.
Core Scope & Technical Deliverables
Conceptual Layout & Flow Design
Drafting layout plans establishing cleanroom zoning, material flows, and personnel entry paths (airlocks) to prevent cross-contamination.
- Personnel & material flow maps
- Airlock & pressure cascade design
- ISO 14644 cleanroom zoning
User Requirement Specifications (URS)
Writing technical URS documents for all production machinery and critical utilities, outlining operational and safety requirements.
- Production machinery URS
- Utility capacity specifications
- Supplier RFQ evaluation support
Design Qualification (DQ)
Executing formal Design Qualification (DQ) studies to verify that all proposed drawings, utility capacities, and machinery specs align with GMP.
- P&ID & layout DQ audit
- Regulatory compliance check
- Capacity & velocity calculations
Construction Supervision & Licensing
Supervising cleanroom finishes, duct sealing, and orbital welding, plus compiling VMP and SOPs for final regulatory licensing.
- HVAC & cleanroom finish check
- Orbital welding inspection
- EDA licensing audit support
Implementation Methodology
Conceptual Layout Design
Drafting layout plans establishing cleanroom zoning, material flows, and personnel entry paths (airlocks) to prevent cross-contamination.
User Requirement Specifications (URS)
Writing technical URS documents for all production machinery and critical utilities, outlining operational and safety requirements.
Design Qualification (DQ)
Executing a formal Design Qualification (DQ) study to verify that all proposed drawings, utility capacities, and machinery specs align with GMP.
Construction Review & Supervision
Supervising physical construction, verifying HVAC duct sealing, cleanroom wall/ceiling finishes, and orbital welding processes.
Commissioning & Licensing Support
Assisting in writing standard SOPs, compiling the Validation Master Plan, and preparing for the final regulatory audit.
Target Sectors & Applications
Our specialized consulting services cater to: