Understanding FDA 21 CFR Part 211 Subpart B: Personnel Responsibilities in Pharmaceutical Manufacturing

The FDA’s regulations under Title 21, Part 211, Subpart B of the Code of Federal Regulations (CFR) are crucial for ensuring the safety, identity, strength, quality, and purity of drug products. These regulations focus on personnel qualifications, hygiene, and health practices within pharmaceutical manufacturing environments. 

 

Personnel Qualifications and Training 

According to 21 CFR 211.25, every individual involved in the manufacture, processing, packing, or holding of a drug product must possess the necessary education, training, and experience to perform their assigned functions effectively. Training should be specific to the operations performed and in current good manufacturing practice (cGMP), including the regulations and written procedures required. This training must be conducted by qualified individuals on a continuing basis to ensure employees remain familiar with applicable cGMP requirements.  

 

Hygiene and Sanitation Practices 

21 CFR  211.28(a) mandates that personnel wear clean clothing appropriate for their duties, including protective apparel such as head, face, hand, and arm coverings, to prevent contamination of drug products. Additionally, personnel are required to practice good sanitation and health habits to maintain a clean manufacturing environment.  

 

Health Conditions and Contamination Control 

Under 21 CFR  211.28(d), any personnel exhibiting signs of illness or open lesions that could adversely affect drug product safety or quality must be excluded from direct contact with components, containers, closures, in-process materials, and drug products. Such individuals may not return to duty until the condition is corrected or deemed non-threatening by competent medical personnel. All personnel are instructed to report health conditions that may affect drug products to supervisory personnel.  

 

Restricted Access Areas 

21 CFR  211.28(c) specifies that only personnel authorized by supervisory personnel are permitted to enter areas designated as limited access within pharmaceutical facilities. This measure helps prevent contamination and ensures that only qualified individuals handle sensitive operations.  

 

Enhance Compliance with BioBoston Consulting 

At BioBoston Consulting, we specialize in assisting pharmaceutical manufacturers to navigate and comply with FDA regulations, including 21 CFR Part 211 Subpart B. Our experts can help your organization develop and implement effective personnel training programs, establish robust hygiene and sanitation practices, and ensure compliance with health and safety standards. Contact us today to learn how we can support your commitment to quality and regulatory compliance.