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Introduction To Good Manufacturing Practice (GMP) Course & Certification
Intermediate
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97% Recommended
3 hours
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About
Introduction to Good Manufacturing Practice (GMP) training provides a foundation in the principles and requirements that ensure pharmaceutical products are consistently manufactured and controlled to the required quality standards. It explains the importance of GMP in protecting patient safety and meeting regulatory expectations.
This Introduction to Good Manufacturing Practice (GMP) Course & Certification covers GMP principles, quality management systems, personnel responsibilities, hygiene, documentation, data integrity, contamination control, deviations, change control, and regulatory compliance. Upon successful completion, learners receive a certification demonstrating their understanding of GMP fundamentals and industry best practices.
Who Should Enrol?
- New Employees in Pharmaceutical Manufacturing
- Production and Packaging Personnel
- Quality Assurance and Quality Control Staff
- Warehouse and Distribution Personnel
- Supervisors and Team Leaders
- Regulatory Affairs and Compliance Professionals
- Contractors and Support Staff Working in GMP Environments
- Anyone seeking a basic understanding of GMP requirements
What you will learn
Understand the fundamental principles of Good Manufacturing Practice (GMP) and their importance in ensuring product quality, patient safety, and regulatory compliance.
Learn the roles and responsibilities of personnel, quality systems, hygiene requirements, and GMP practices within pharmaceutical manufacturing.
Develop knowledge of documentation, data integrity, contamination prevention, deviations, and change control to support GMP compliance.
Gain an understanding of regulatory expectations, inspections, and best practices for maintaining a compliant pharmaceutical manufacturing environment.
Course Syllabus
- GMP organisational roles and the Quality Unit
- Quality Unit independence and authority
- Written responsibilities and training
- Hygiene, gowning and visitor control
- Location, layout and unidirectional flow
- Construction and surfaces
- Cleanroom grades (EU A-D / ISO 14644)
- HVAC, pressure cascade and utilities
- Equipment design for GMP
- Qualification: IQ, OQ, PQ
- Calibration and maintenance
- Cleaning validation and status control
- Material categories and lifecycle
- Receipt, quarantine and QA release
- Storage, FEFO and status control
- Dispensing and traceability
- The Pharmaceutical Quality System (ICH Q10)
- Three objectives and four enablers
- CAPA, change control and deviations
- Document hierarchy and management review
- Master and batch records (MBR / BMR)
- Line clearance and in-process controls
- Yield and reconciliation
- Deviations and batch release
- The validation lifecycle
- Process validation approaches
- Cleaning validation and limits
- Computer-system and analytical-method validation
- Contract Giver and Acceptor responsibilities
- The mandatory Quality Agreement
- Qualification and technology transfer
- Oversight, audits and data integrity
- Good Distribution Practice and cold chain
- Ongoing stability
- Complaints and recalls
- Annual Product Review (APR/PQR)
- Physical, data and supply-chain security
- ALCOA++ data integrity
- Cybersecurity and audit trails
- Serialisation and counterfeit prevention
- Internal, supplier and regulatory audits
- The audit cycle and finding classification
- Inspection readiness and conduct
- Responding to findings and repeat findings
- EHS and GMP interfaces
- Hierarchy of controls
- Waste, effluents and emissions
- Sustainability and emergency preparedness
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay grounded in the regulations that define GMP worldwide - WHO TRS 986, FDA 21 CFR Parts 210/211 (drugs) and 820 (devices), EU GMP Parts I and II, ICH Q7, Q9 and Q10, plus PIC/S, MHRA, PMDA and Health Canada overlays, and data-integrity expectations under 21 CFR Part 11 and ALCOA++.
Learn from Industry Experts
The course is clause-anchored and audit-aware, written by GMP practitioners and framed around the FDA 483 observations and EU non-compliance themes that inspectors cite most often.
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