Personnel requirements are addressed in the General Good Manufacturing Practices part of CFR Title 21 (section 211.25), the General Biological Good Manufacturing Practices 21 CFR 600.10 and the cGMP for Blood and Blood components, section 606.20.
The common themes in all these sections are:
- There must be an adequate number of personnel who are qualified by education, training, and experience for their job duties.
- Training by qualified individuals must include good manufacturing practices.
- Periodic training updates must occur to ensure compliance with the regulations.
- Access to work areas should be limited.
- Appropriate protective clothing must be worn to protect the drug products (blood products) from contamination.