How Training Should Be Run Under GMP

How Training Should Be Run Under GMP

Training is one of the core GMP (Good Manufacturing Practice) requirements. The operation must have a training plan, and the training needs must be identified. The content should be practical rather than only theoretical, and alongside general training, each production sector's specific training should be included. Sistem Patent Kalite supports the full training programme under GMP.

Training requirements and criteria under GMP can be summarised as follows:

• All staff on the production site must be trained, including cleaning staff.
• New staff joining production receive full product-related training, applied in practice, before working on the line.
• Training is delivered against a plan, with effectiveness reviewed after each session.
• The training plan is documented and approved by management and by the quality management representative.
• Staff working with sensitive, hazardous, or contaminated products receive specific training. Contaminants are explained, and emergency procedures are rehearsed.
• A visitor instruction is documented, and access to production areas is controlled. The instruction is communicated to all staff, including escorts.
• Where site visits to production are unavoidable, hygiene conditions and access rules are defined and applied.
• Hygiene training is accompanied by quality management system training and documentation training, so records are clear and audit-ready.
• Training is a fundamental across all standards, but under GMP the emphasis on practical, application-level training is particularly important.

How Sistem Patent Kalite Helps

We build the GMP training programme together with the client, cover the topics above in modular sessions, and track attendance and effectiveness through the records the auditor will expect to see. Contact us for a scoped quote.