Microorganisms、too embarrassed to ask others about！（Part 13）

5.5 Raw Materials, and Labeling and Packaging Materials

 <Notes>
1. Since most raw materials and materials are purchased from outside sources, there are limits to manage on your own; proper supplier management is necessary, as required by ISO 13485 and PICS GMP.

2. As a control when raw materials are delivered to the company, procedures to prevent introduction microorganisms from the outside environment. Particular attention should be paid to spore-forming bacteria and fungi as microorganisms most likely to be attached to raw materials. 

3. Some raw materials may have inherent contaminating microorganisms. For instance, blood maybe contaminated with viruses such as HBV, HCV, or HIV. Biological raw materials may also contain viruses or prions.

5.6 Operator Control

<Notes>
1. Presence of operators poses an extremely high risk of microbial contamination in the manufacturing process of drug products and medical devices. A number of microorganisms lives on the body surface of operators. It is impossible to completely eliminate them (sterilize humans). Therefore, education and training on microorganisms is required in microbiological control related to the operators.

2. Operators must change clothes and wash hands when entering the production area and coming in contact with the product. Rules and requirements for those activities will vary depending on the product or process in question. A risk assessment should be conducted to clarify the requirements before determining the procedure.

3. Spore-forming bacteria and fungi are most likely to be brought into the production area by operators from outside environment, but attention should also be paid to skin commensal bacteria and oral bacteria carried by the operators themselves.

4. When an operator has an infectious disease, it may be necessary to remove him/her from certain tasks or restrict his/her access to the clean room.  Access the risk appropriately and establish necessary procedures to take action.

5. With regard to people management, in addition to operators, attention must be paid to visitors and distributors. With regard to infectious diseases, overseas travelers must also be properly controlled.