Frequently Asked Questions

All personnel must receive initial GMP training relevant to their duties and continuing training thereafter. Training must be conducted by qualified individuals. Training effectiveness must be assessed periodically. Detailed records including topic, date, trainer name, and assessment results must be maintained. Personnel in contamination-risk areas need additional specialized training.

Written gowning procedures must be established for each production area based on its cleanliness classification. For Grade A/B areas, personnel must wear sterilized protective clothing including head covering, face masks, gloves, and footwear. The gowning procedure itself must be validated to demonstrate that garments don't introduce unacceptable particulate or microbial contamination levels.