The GMP-EU, issued by the European Medicines Agency (EMA), prescribes guidelines about good manufacturing practice standards for pharmaceutical products. In order to create a high-quality medicinal product, the participation of the human factor is indispensable. In this article, let’s find out information about personnel in the GMP-EU.
1. General regulations for personnel in GMP-EU.
Manufacturing facilities and businesses wishing to build factories meeting GMP-EU standards must meet the following basic requirements for their staff:
– Sufficient staff with professional qualifications and practical experience to undertake specific tasks. Avoid assigning tasks to employees excessively. Provide all necessary resources in terms of human, financial, machinery, etc. to implement and maintain the quality management system and continuously improve the system effectively.
– CHaving an organization chart showing the management hierarchy and the relationship between the person in charge of production, quality control or the person in charge of expertise and the staff.
– Having a specific and detailed job description about the duties of each personnel in the GMP-EU. Minimize gaps or overlaps in work related to the application of GMP-EU Good Manufacturing Practice.
– Guests or employees who have not been trained in GMP-EU standards should not be allowed into the production and quality control areas. If not avoided, they need to be closely monitored by the staff in charge so as not to affect the production process and product quality.
– The Board of Directors is ultimately responsible for ensuring the effectiveness of the quality management system, meeting GMP standards by participating in the review of the management system.
2. Other requirements on personnel acc.to GMP-EU standards.
In addition to the general regulations for personnel in the EU GMP, the factory leadership also needs to pay attention to the principles and standards governing key employees, training, consulting, and personal hygiene of employees. .
– Key personnel: must clearly identify the staff in charge of the position of Head of Production and Head of Quality Control. This key position is usually filled by official factory employees. Head of Production and Head of Quality Control must have clear roles, responsibilities, and powers and must work independently of each other.
– Training: Personnel in the GMP-EU, including technical, maintenance and cleaning staff, must be trained continuously and periodically update the contents of the GMP-EU standards. Especially intensive training for employees working in hazardous areas, infectious, high risk of adulteration. Minimize the presence of untrained people in production and testing areas to minimize risks that may affect product quality.
– Personnel hygiene: absolutely prohibiting illegal acts such as eating, drinking, smoking… in production areas or areas that may affect the quality of pharmaceutical products. Employees must wear appropriate protective clothing before entering the production area, carrying out professional work.
– Consulting service: has a team of trained and experienced consultants to help solve problems arising in the production process.
In order to produce high-quality pharmaceutical products, there is a need for smooth coordination between machines and people. Therefore, not only needing modern production lines but also ensuring personnel requirements in GMP EU is also one of the top priorities of pharmaceutical companies and enterprises.
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