What specific requirements apply to staff training records for a pharmaceutical licence application? How long must they be retained?

Training record management is an important part of a pharmaceutical quality management system, and regulators have clear requirements in this area. First, all staff involved in licensed activities must receive initial and ongoing training appropriate to their duties. Second, detailed records must be kept of every training activity. Training records should generally include the date, topic, outline of content, trainer’s name and qualifications, and the signatures of participating staff. For key training in Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP), it is also advisable to keep records of post-training assessments or evaluations. All such training records must be properly retained. As a general recommendation, retain records for at least 5 years or, where specific product expiry requirements apply, for the longer period.