We offer insight into one of the greatest challenges facing the biopharmaceutical industry today: employee training.
Regulatory requirements
Regulations for biopharmaceutical employee training are laid out clearly and echoed globally. The United States (US) Part 211 of current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals details the expectations for employee training. In Section 211.25 on personnel qualification, it states that each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Section 211.100 states that written procedures must be followed and documented for production and process control at the time of performance. The same requirements are listed in EudraLex Volume 4, Chapter 2 on personnel.
Yet, if you analyze Form 483 citations published by the US Food and Drug Administration (FDA) over the last 10 years, 25-35% cite Part 211 violations. There are various infractions associated with lack of compliance to documented procedures, non-existence of documented procedures, or less than adequate training. These findings add up and are a great challenge for the biopharmaceutical industry to overcome.
The impact of the challenge
The greatest risk of insufficient employee guidance and training is human harm. Secondly, missing or improper documentation paired with ineffective training, leads to quality issues and lost batches, which cost time and money. Finally, non-compliant processes lead to deviation investigations and corrective and preventative action (CAPA) implementation.
When regulators come in to evaluate the situation, operational failures are frequently assigned to operator error; retraining will then be ordered as part of the CAPA. However, this is not the biggest issue. If regulators see multiple unresolved investigations, it will be determined that the manufacturer's GMP standards are probably unacceptable, which can have far-reaching regulatory implications.
Quality-driven training
The United States Food and Drug Administration (US FDA) wants to put more onus on the biopharmaceutical industry to approach training issues and resolve them. In fact, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), has expressed a vision of an industry working at a high-quality level without needing as much major regulatory oversight—one that builds quality in as a given at all stages of a process. However, pursuing this vision requires a multi-pronged approach to successfully:
1. Offer straightforward and crisp documentation that can be shared and consumed on demand whenever a reference point is needed.
This includes standard operating procedures (SOPs), working instructions (WIs) and batch records (BRs).
2. Create efficient training programs that align with the documentation and are driven by clear Good Manufacturing Practices (GMPs).
Training cannot be isolated and must be ongoing to empower employees to continue learning and growing in their skill set.
3. Create an ecosystem that encourages operator judgement and proactivity instead of just pushing a button.
Automation and intuitive design complement this goal.
4. Enable operators to execute proper root cause investigation and make corrective and preventative actions (CAPAs) an inherent part of daily operations if/when needed.
Give employees the tools they need to mitigate and resolve issues immediately. This is not to avoid regulatory oversight, but to ensure that when the regulators come in, things are being done the right way the first time.
5. Bridge the gaps between suppliers and end-users to support strong communication and collaboration.
At every point in a process, from sourcing a supplier to being on the production floor, clear communication and understanding of what a process is trying to achieve is a necessity. This includes process documentation and data analysis to allow employees to continue to learn as a process evolves.
Next generation solutions
At Cytiva, we ensure that our training programs are up-to-date with the latest technology and insights, to help you and your staff prepare for today and the future.