This training has been designed to provide a solid and applied understanding of Good Manufacturing Practices (GMPs) to personnel who are directly or indirectly involved in the manufacture, conditioning, control and release of product.
The training goes beyond theoretical knowledge of the regulations, helping participants understand why GMPs exist, how they are applied on a day-to-day basis and what real impact individual behavior has on product quality and end-user safety.
Objective
The aim of the course is for participants to understand the fundamental principles of GMPs and to be able to apply them consistently in their workplace, even in situations that are not ideal or not explicitly described in the procedures.
It seeks to reinforce the culture of quality, promote individual responsibility and reduce the risk of deviations, documentary errors and regulatory observations, ensuring that the medicines manufactured are safe, effective and of consistent quality.
Key contents
During the course, the basic principles of GMPs are reinforced and critical aspects such as:
- Fundamental principles of quality and GMPs
- Regulatory framework and health authorities (EMA, FDA and other agencies)
- Facilities and equipment: design, proper use and maintenance
- Prevention of contamination and cross-contamination
- Personnel and material flows
- Cleaning, order and control of areas
- GMP Documentation and Data Integrity Principles (ALCOA/ALCOA+)
- Records, frequent errors and good documentary practices
- Role of personnel in GMP compliance and patient protection
- Basic management of deviations and operational errors
The approach is eminently practical, using real examples and common plant situations.
Modality, duration and evaluation
- Standard duration: 1 day of approximately 2 hours (adaptable according to needs)
- Methodology: Applied theory + real examples + practical exercises + guided debate
- Modality: Face-to-face (preferred) or live online
- Materials: Course manual, examples of GMP documentation, practical exercises and certificate of attendance.
This course can be delivered as initial training, regular GMP training, or as reinforcement after inspections, recurrent deviations or organizational changes.
This training program is aligned with current regulatory requirements (annex I) and aimed at improving GMP compliance, strengthening the quality culture and reducing operational risk in pharmaceutical environments. It can be integrated into a comprehensive staff qualification and training plan.