Training
GMP (Good Manufacturing Practices) Training
MEANING: What is GMP Training?
GMP (Good
Manufacturing Practices) are a set of guidelines and regulations that ensure
products (especially food, pharmaceuticals, cosmetics, and medical devices) are
consistently produced and controlled according to quality standards.
GMP training is the
process of educating employees on the principles, procedures, and legal
requirements of GMP to ensure safe, high-quality, and compliant manufacturing
practices.
PROCESS: Steps in GMP Training
1. Training Needs Assessment
Identify who needs
training (production staff, quality control, warehouse, maintenance,
management)
Determine level of
training:
GMP Awareness
Advanced GMP for
Quality/Regulatory roles
Refresher training for
ongoing compliance
2. Training Design & Planning
- Set objectives: e.g., hygiene, documentation,
validation, traceability
- Choose delivery methods: in-person, e-learning,
workshops, on-the-job coaching
- Align with regulatory standards (e.g., US FDA CFR 21
Part 210/211, WHO GMP, EU GMP)
3. Training Content
Typical modules
include:
- Introduction to GMP principles
- Personal hygiene and contamination control
- Facility and equipment cleanliness
- Raw material handling and storage
- SOPs and batch record documentation
- Product identification and traceability
- Deviation, CAPA (Corrective and Preventive Action), and
change control
- GMP audits and regulatory inspections
4. Training Delivery
- Use real-life examples and workplace scenarios
- Include visual aids (videos, photos of good vs bad
practices)
- Encourage questions, discussions, and
hands-on activities
5. Evaluation and Certification
- Test employee understanding (quizzes, practical
assessments)
- Issue training completion certificates
- Document training records for audit
purposes
6. Ongoing Training and Improvement
- Schedule refresher courses annually or after major
changes
- Update training materials based on audit findings or
new regulations
- Encourage continuous improvement and employee feedback
