Classroom
14 sessionsOnline / Live
14 sessionsIntroduction
Course overview
Good manufacturing practice ensures that medicines, food supplements, cosmetics and related products are consistently produced and controlled to quality standards. GMP failures can lead to recalls, regulatory action and patient harm.
This Aractech course explains GMP principles and regulations, quality systems, personnel and training, premises and equipment, documentation and data integrity, production and process controls, quality control, deviations and CAPA, and inspection readiness. Participants apply GMP requirements to practical scenarios.
The course provides a solid foundation for new and experienced GMP staff.
What you will achieve
Learning objectives
- Explain GMP principles and regulatory frameworks
- Understand quality system requirements
- Apply GMP to personnel, premises and equipment
- Maintain good documentation and data integrity
- Manage deviations, CAPA and change control
- Prepare for GMP inspections
Who should attend
Target audience
- Production and QA staff in regulated manufacturing
- Quality control laboratory staff
- Engineering and maintenance staff
- Warehouse staff
- Supervisors
- New GMP employees
Methodology
Learning approach
- Regulation-based presentations
- Practical scenarios
- Documentation exercises
- Inspection case studies
- Group discussions
Complete course outline
Five focused days of learning and application
The timings provided are estimates and may vary depending on the number of participants and the discussions taking place during the sessions. They are indicative only and do not constitute a binding commitment.
Day 1
GMP Fundamentals
- What GMP is
- Regulatory frameworks
- Quality systems
- Responsibilities
- Coffee break
- Responsibilities (continued)
- Consequences of non-compliance
- Exercise: GMP scenarios
Day 2
Personnel, Premises and Equipment
- Training and hygiene
- Facility design
- Cleaning
- Coffee break
- Cleaning (continued)
- Equipment qualification
- Maintenance
- Workshop: Facility review
Day 3
Documentation and Data Integrity
- Good documentation practice
- Batch records
- Data integrity principles
- Coffee break
- Data integrity principles (continued)
- Electronic records
- Common errors
- Exercise: Documentation review
Day 4
Production and Quality Control
- Process controls
- Validation
- Sampling and testing
- Release
- Coffee break
- Release (continued)
- Deviations and CAPA
- Case study: Deviation investigation
Day 5
Inspection Readiness
- Self-inspection
- Inspection conduct
- Responding to findings
- Coffee break
- Responding to findings (continued)
- Change control
- Continuous improvement
- Capstone: GMP improvement plan
FAQ
Frequently asked questions
What does Good Manufacturing Practice (GMP) Essentials (QP-021) cover?
This course covers Quality and Productivity through a structured five-day outline focused on practical application, discussion, and implementation planning.
When is the next available session?
The next scheduled session starts on 16 - 20 November 2026. See the course schedules section for the available dates and delivery formats.
Who should attend this course?
Production and QA staff in regulated manufacturing, Quality control laboratory staff, Engineering and maintenance staff
Is bilingual course delivery available?
Yes. All course materials and presentations are provided in English, while bilingual explanation and discussion support may be available depending on the selected location and trainer availability. For example, when attending a course in Istanbul, you may request a Turkish-speaking trainer to explain the English course content in Turkish. Arabic explanation support may also be requested at this location. Other languages are available in selected cities. You can choose your preferred language support as an optional preference during registration.
How can I register for a session?
Use any Register button next to the available course dates to open the participant registration page and submit your booking request for the selected session.
Is this course available online as well as classroom-based?
Check the course schedules section for currently published classroom and Online / Live sessions.
Where are classroom sessions delivered?
Current classroom venues include Rome, Munich, Barcelona, Cape Town, Frankfurt, Geneva, Paris.
How long is the training programme?
The programme runs for five days from 09:00 to 14:00, which gives 25 contact hours, including a daily 30-minute break (22.5 hours of instruction).
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Choose an available date and venue, add your participants, and we will email a formal quotation for Good Manufacturing Practice (GMP) Essentials to your business address.
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