GMP for Pharmaceutical Facilities, Equipment & Utilities
Design, qualify and maintain GMP-compliant facilities, equipment and utilities. The course covers regulatory expectations, materials and surfaces, zoning, DQ/IQ/OQ/PQ, quality risk management, HVAC and water utilities, and maintenance and calibration programmes.
At a glance
- 3 days
Who it's for
- Engineering, validation & maintenance staff in pharma (2+ years' experience)
- QA and production personnel
- Experienced practitioners updating on science- and risk-based approaches
Learning objectives
- Understand international regulatory requirements for pharma facilities, equipment and utilities
- Understand design, materials of construction and surfaces
- Apply zoning for sterile and non-sterile operations
- Plan qualification (DQ/IQ/OQ/PQ) of facilities, equipment and utilities
- Link QRM principles to design and operation
- Understand water, compressed air, steam and chilled-water systems
- Set maintenance and calibration programs
Detailed content
- EU GMP (incl. Annex 1 & Annex 15), FDA, WHO, PIC/S
- Facility design & construction aspects
- Equipment hardware & software design
- Zoning concepts (sterile & non-sterile)
- Materials & surfaces
- Facility qualification & validation regulations
- Routine operation concepts
- Documentation for construction, upgrade & renovation
- QRM principles & tools (ICH Q9(R1))
- Documented rationale for decisions
- Pharmaceutical water systems
- Compressed air, steam & chilled water
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Regulatory Position
- GMP-Compliant Design
- Qualification & Validation
- Quality Risk Management
- Utilities
- Maintenance & Calibration Programs
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Calculate OEE and the six big losses from a real machine log
- Failure analysis of a recent breakdown (5-Why, fishbone, FMEA)
- Build a preventive / autonomous maintenance plan for one asset
- Variable Gage R&R study with three appraisers
Tools and templates you keep
- OEE calculator (Excel)
- PM schedule and CIL (clean–inspect–lubricate) sheet
- Breakdown analysis report template
- Gage R&R data sheet and decision guide
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
- JIPM TPM pillars
- SMRP Body of Knowledge
- ISO 55000 (asset management)
Certificate
Excellence Center Certificate of Attendance
Prerequisites: Basic GMP, QRM and QMS knowledge; Intermediate English
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 · Practitioner
Frequently asked questions
How long is GMP for Pharmaceutical Facilities, Equipment & Utilities?
The program runs 3 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 in Pharmaceutical Laboratories2 days
- Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 days
- Good Manufacturing Practices (GMP) for the Pharmaceutical Industry5 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.