21 CFR 600.10 - Personnel - Biological Products

What it says

Personnel engaged in the manufacture of biological products must have the education, training and experience needed to perform their assigned functions, and must be excluded from direct contact with products if they have a disease or condition that could adversely affect product safety.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Because biological products are manufactured using living systems and are more susceptible to microbial and cross-contamination risk than many conventional drug products, personnel health screening carries particular weight in biologics manufacturing.
• Training requirements here extend beyond a one-time qualification, personnel working in biologics manufacturing are expected to maintain and demonstrate ongoing competency for their specific assigned functions.
• This provision connects to broader aseptic technique and gowning qualification expectations, since personnel are one of the most significant contamination sources in any biologics manufacturing environment.

What FDA inspectors look for

• Whether personnel health screening and exclusion procedures are actually in place and followed for staff with direct product contact.
• Whether training records demonstrate ongoing, function-specific competency rather than a single initial qualification event.
• Whether personnel gowning and aseptic technique qualification, where applicable, is documented and periodically reassessed.

Related regulations