Requirements on personnel training according to GMP EU regulations
The manufacturer must have a training program for all employees involved in the production, storage areas, or control laboratories (including technical, labor, and sanitation personnel). Also, include other workers whose activities may affect product quality.
In addition to basic theoretical training such as quality management practices and Good Manufacturing Practices, newly recruited personnel need to be trained following the assigned work. Training must be ongoing, and the actual effectiveness of the training must be periodically evaluated. Training programs must be available and approved by either the head of the production department or the quality manager. Training records must be kept.
Detailed training should be provided to personnel working in areas with a risk of contamination, for example, in clean rooms or spaces where highly reactive, toxic, infectious materials are present. or sensory sensors need to be processed.
Visitors and untrained employees do not participate in production or quality control areas. In force majeure, such persons must be given information, especially about personal hygiene and protective clothing as prescribed.
The system quality system, and all methods capable of improving performance and perception, are thoroughly discussed in the training sessions.
Personal hygiene according to GMP EU standards
Specific personal hygiene programs must be established and tailored to the different needs of the plant. Such programs must include procedures related to health, hygiene practices, and employee clothing. Employees involved in production and control areas must understand the processes and follow them strictly. Sanitation programs should be promoted by the manager and widely discussed in discussions.
All employees must undergo a medical examination upon hiring. It is the responsibility of the manufacturer to have instructions in place to ensure that health conditions may be related to the quality of the product.
Steps should be taken to ensure that no person is affected by an infectious disease or has open lesions that interfere with the manufacture of medicinal products.
Everyone entering production areas must wear appropriate protective gear.
Actions including eating, chewing, smoking or bringing food, drink, tobacco or personal drugs into production or storage areas are prohibited. Any actions or factors that may adversely affect product quality should be banned.
Direct contact between the operator’s hands and the open product shall be avoided with any part of the equipment involved in connection with the products.
Workers must be instructed and trained to use hygiene tools.
Any specific requirements for the manufacture of special product groups, such as sterilization preparations.