Article 29 All personnel shall be trained in hygiene requirements, and enterprises shall formulate hygiene operation rules for personnel to minimize the risk of pollution caused by personnel to pharmaceutical production.
Thirtieth personnel hygiene operation procedures should include the contents related to health, hygiene habits and personnel dress. Personnel in the production area and quality control area should correctly understand the hygiene operation procedures of relevant personnel. Enterprises should take measures to ensure the implementation of hygienic operation procedures.
Article 31 An enterprise shall manage the health of its employees and establish health records. Production personnel who are in direct contact with drugs should undergo health examination before taking up their posts, and then at least once a year.
Enterprises should take appropriate measures to prevent people with wounds, infectious diseases or other diseases that may contaminate drugs from directly engaging in drug production.
Thirty-third visitors and untrained personnel are not allowed to enter the production area and quality control area. Special circumstances really need to enter, should do a good job in advance of personal hygiene, dressing and other matters of guidance.
Thirty-fourth people entering the production area should change their clothes according to the regulations. The material, style and wearing method of work clothes should be suitable for the work they are engaged in and the requirements of air cleanliness level.
Personnel entering the clean production area are not allowed to wear makeup or accessories.
Smoking and eating should be prohibited in production areas and storage areas, and non-productive items such as food, beverages, cigarettes and personal medicines should be prohibited.
37. Operators should avoid direct contact with drugs, packaging materials and equipment surfaces with their bare hands.
If necessary, please refer to CGMP of EU and USA.