GMP Training for Pharmaceutical Factories
Good Manufacturing Practice training aligned with EDA requirements and WHO GMP standards — built for pharmaceutical factory teams in Egypt who need GMP compliance that survives an inspection, not just a certificate that says so.
GMP compliance in Egypt is not a one-time certification. It is an ongoing operational standard.
The Egyptian Drug Authority (EDA) enforces Good Manufacturing Practice requirements for all pharmaceutical manufacturing facilities operating in Egypt. GMP compliance is required for factory licensing, registration dossier submission (where manufacturing site GMP certificates are part of Module 3), and ongoing operation — with the Industrial Development Authority (IDA) verifying GMP and Good Storage Practice (GSP) compliance before issuing operation licences.
EDA inspectors are trained to WHO GMP standards. Egypt has progressively aligned its GMP framework with WHO GMP, ICH Q10 (Pharmaceutical Quality System), and EU GMP principles. An inspection team from EDA will look for evidence that GMP principles are embedded in daily operations — not demonstrated during the inspection and forgotten afterwards.
EMCO Egypt's GMP training is built around what EDA inspectors actually examine, what the most common findings are, and how to build a manufacturing quality culture that holds up between inspections.
Who this training is designed for
QA / QC Teams
Quality assurance and quality control professionals responsible for maintaining manufacturing standards, approving batch records, managing deviations, and overseeing the quality management system. The first team EDA inspectors want to speak with.
Production & Operations
Production managers, supervisors, and operators who need to understand GMP principles in the context of their daily work — not in the abstract. Batch documentation, contamination control, equipment maintenance, and in-process controls all in operational practice.
Regulatory Affairs & Management
Regulatory affairs professionals who need to understand GMP as it relates to registration dossiers (Module 3 manufacturing documentation) and post-approval variation management. Factory directors and senior management who are responsible for the quality culture but not always close to daily operations.
What the training covers
- GMP fundamentals — WHO GMP principles, EU GMP alignment, ICH Q10 Pharmaceutical Quality System, how EDA enforces GMP in Egypt
- Personnel — roles, responsibilities, hygiene requirements, GMP training records and competency documentation
- Documentation — batch manufacturing records, SOPs, logbooks, data integrity principles, and what inspectors look for in records
- Manufacturing controls — in-process controls, contamination prevention, environmental monitoring, and equipment qualification
- Change control & deviations — formal change control systems, deviation reporting, root cause analysis, and CAPA management
- Quality management system — internal audit processes, product quality reviews, supplier qualification, and complaint handling
- EDA inspection preparation — what EDA GMP inspectors examine, the most common critical and major findings, and how to prepare the quality team for inspection interviews
- Factory licensing requirements — EDA and IDA licensing requirements for pharmaceutical manufacturing facilities in Egypt
Format: 2–3 days | In-person or on-site | Arabic and English | Customisable by factory type and production scope
Why this training comes from EMCO Egypt
EMCO Egypt's regulatory practice spans pharmacovigilance, eCTD dossier submission, and drug registration — all of which connect directly to GMP compliance. Module 3 of a registration dossier requires current GMP documentation for every manufacturing site. Variations affecting manufacturing processes require GMP-aligned change control records. Post-approval regulatory correspondence often involves GMP questions from the authority.
Our GMP training reflects this cross-functional regulatory perspective. It is not generic manufacturing quality training adapted to the pharma context — it is pharmaceutical GMP training designed specifically for companies operating under EDA requirements, often alongside active registration and pharmacovigilance obligations.
GMP compliance starts with people who understand what it means — not just where to find the SOP.
Individual and group enrolment open year-round. On-site programmes available for manufacturing facilities with minimum two weeks' lead time. Programme scope is customised to your factory type, production processes, and current compliance status.
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