Good Manufacturing Practices (GMP) for the Pharmaceutical Industry
A comprehensive GMP course for the pharmaceutical industry. Participants learn US, EU, WHO and PIC/S requirements, apply GMP to daily operations, understand qualification and validation, handle deviations and CAPA, and prepare for regulatory inspections.
At a glance
- 5 days
Who it's for
- Staff in GMP environments, beginner to advanced, who must understand and apply cGMP
Learning objectives
- Explain US, EU, WHO and PIC/S GMP requirements and the hierarchy of laws, regulations and guidance
- Apply GMP fundamentals to pharmaceutical operations
- Understand validation and qualification
- Prepare for and manage regulatory inspections
- Handle deviations, CAPA and change control
Detailed content
- FDA, EMA, WHO, PIC/S & local authority requirements
- Hierarchy of laws, directives, regulations & guidance
- Organisation & personnel
- Facilities & equipment
- Writing effective SOPs
- Process controls & master batch records
- Vendors & material control
- Product release & distribution
- Complaints & recalls
- Data integrity (ALCOA+)
- Qualification vs validation
- Cleaning validation
- Clean-room design & validation (EU GMP Annex 1, 2022)
- Sterilisation validation (heat, filtration)
- Water system design & validation
- Validation documentation
- Internal audits; gap analysis & remediation
- CAPA & change control
- GMP training
- Regulatory inspections & preparation
- Self-inspection & third-party audits
- Common deficiencies & warning letters; current hot topics
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- GMP Basics & Regulations
- Operations
- Validation
- Compliance Systems
- Inspections
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Aspects-and-impacts register for a real site
- Compliance-obligations review exercise
- Build a HACCP plan for one product: flow diagram, hazards, CCPs, limits
- PRP/GMP inspection walk with nonconformity reporting
Tools and templates you keep
- Aspects/impacts significance matrix
- Legal register template
- HACCP plan worksheets (hazard analysis, CCP decision tree)
- PRP/GMP inspection checklist
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- ISO 14001:2015
- Egyptian Environmental Law 4/1994 and executive regulations
- Codex Alimentarius CXC 1-1969 (General Principles of Food Hygiene, 2022)
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Part of these career paths
- Pharma, Medical Devices & Food Safety · Foundation
Frequently asked questions
How long is Good Manufacturing Practices (GMP) for the Pharmaceutical Industry?
The program runs 5 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
More programs in this field
- HACCP and Food Safety Risk Analysis
- ASQ CPGP – Certified Pharmaceutical GMP Professional (Exam Preparation)15 days
- GMP Auditor Training for Quality Systems2 days
- GMP for Medical Devices (ISO 13485)2 days
- GMP for Pharmaceutical Facilities, Equipment & Utilities3 days
- GMP in Pharmaceutical Laboratories2 days
- Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 days
- Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring4 days
- Pharmaceutical Water Systems: Principles & Practice2 days
Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.