Service Overview
In the pharmaceutical, biotechnology, and medical device manufacturing industries, having a robust Quality Management System (QMS) is the foundation of regulatory compliance and product quality. A QMS is not just a collection of documents; it is a systematic framework that ensures all manufacturing processes, equipment, and analytical methods consistently conform to standard requirements.
At QEEMA Egypt, we specialize in building, optimizing, and auditing QMS platforms. Whether you are aiming for ISO 9001 registration, preparing for an ISO 13485 medical device audit, or building a comprehensive Good Manufacturing Practice (GMP) system to satisfy local EDA and international WHO/EU GMP inspections, our experts provide tailored documentation and consulting support.
Core Scope & Technical Deliverables
ISO 9001 & GMP Implementation
Full architecture and implementation of quality manuals, quality policy frameworks, and standard operating procedures aligned with ISO and GMP standards.
- Quality Manual & Policy drafting
- Site Master File (SMF) creation
- GMP compliance framework
Internal Audits & Gap Analysis
Thorough gap analysis of plant operations and execution of mock regulatory audits to pinpoint deficiencies prior to official inspections.
- Comprehensive gap assessment
- Mock EDA & ISO audit simulations
- Auditor coaching & training
CAPA & Deviation Management
Designing robust Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) tracking logs, and formal Change Control systems.
- Fishbone & 5-Why RCA tools
- CAPA effectiveness verification
- Formal change control logs
Staff Quality Training & SOPs
Interactive staff training on SOP execution, Good Documentation Practices (GDP), hygiene rules, and regulatory audit behavior.
- Good Documentation Practice (GDP)
- Operational SOP training
- Quality culture development
Implementation Methodology
Gap Analysis & Facility Audit
Performing an on-site audit of existing procedures and practices against target regulations (ISO, GMP) to identify omissions.
Document Architecture & SOP Drafting
Designing your QMS documentation index and drafting SOPs, quality manuals, validation templates, and batch records.
Process Implementation & Training
Training management and plant operators on new SOPs, deviation reporting, CAPA registers, and change control.
Internal Audits & Simulations
Executing mock regulatory audits to test QMS performance, evaluate staff response, and identify remaining gaps.
Regulatory Audit Support
Our consultants remain on-site during your licensing inspection to support document retrieval and resolve auditor questions.
Target Sectors & Applications
Our specialized consulting services cater to: