After all the effort, years, and resources that go into developing a drug formula that meets FDA, EMA, and other approvals, it is imperative that the bulk manufacturers of the drug product produce it to exact specifications. Inadequately skilled or trained manufacturing staff can pose a threat to productivity and product quality, which can be costly or even devastating. For pharmaceutical manufacturers, the skill level of the people operating the machinery, as well as those in the support functions, are as important to the company’s success as the quality of its facilities or track record of accomplishments. If a manufacturing batch fails due to inadequate worker skill and is rejected by the customer, costs can be measured in lost production materials and time, delays for other customers while the batch is repeated, and, very likely, a tarnished reputation. More broadly, surveys (1–3) show that employees are more satisfied at work when companies invest in their development, while organizations that spend on training are more likely to generate higher profit margins and income per employee, among other financial measures, than those that don’t.
Investing in worker training is, therefore, crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.
Rottendorf Academy
Most German manufacturing facilities take advantage of the German education system’s culture of apprenticeships, which yields workers who are certified in a trade. While certification may not be specific to pharmaceutical manufacturing, it provides a strong foundation that can be built upon. With this foundation, it is important to bring all certified machine operators and pharmaceutical technicians to the highest standard of knowledge and performance. Rottendorf has consequently taken a formal approach to internal training.
Rottendorf Academy was founded to distribute and elevate the skills of its workers by sharing the skills and knowledge of the best, most experienced operators and technicians. This approach avoids the “one-size-fits-all” learning often offered by external training providers, and provides opportunities for the employees. Academy courses are aligned in modules, and workers may enroll in different courses within each module. For example, basic, theoretical training courses are available for certified machine operators (also called chemical production specialists), who focus on granulating, mixing, tableting, and coating, and for pharmaceutical technicians, who are interested in gaining additional knowledge in more than one department, such as quality control, the warehouse, and packaging, to provide operational flexibility. Workers learn everything from personal hygiene requirements for manufacturing environments to regulatory requirements and how to operate the variety of highly technical machinery in bulk manufacturing and packaging facilities. In addition to learning how to operate machinery, they learn the whys behind each phase of the manufacturing process, and how to determine good products from bad ones. This understanding helps operators to identify issues at the earliest possible stages throughout the manufacturing process and take appropriate actions.
Classes are taught by master operators and technicians, people at the top of their game in skill level and able to mentor and guide the development of a new employee. These masters of their craft transfer, over time, their knowledge of customers, processes, instruments, regulatory requirements, and practical expertise. The training is designed to deepen an employee’s understanding of the manufacturing process and critical process parameters, provide practice troubleshooting problems, instill knowledge of GMP requirements, and transfer theory to practice. All this classwork is complemented by on-the-job training and, to improve the practical application of class learning, mentors are used to enable less-skilled workers to apprentice in their jobs. Machine operators apprentice for two years, while pharmacy technicians apprentice for 3.5 years. Experienced operators explain, demonstrate, and evaluate each new operator’s performance to ensure all machinery is properly run and all processes are properly followed. Periodic, ongoing training increases knowledge and competence. It takes up to one year to bring a new employee up to speed and more than three years to achieve master craft level, but the investment is worth it. The average Rottendorf employee has been with the company 11 years, with many in the manufacturing division staying with the company much longer.
Overall, the goal is to bring all operators and technicians to the master level. Rottendorf Academy ensures all employees possess the basic required knowledge to successfully do their jobs. It provides a forum for continuously enhancing their understanding of the machinery in use, the processes involved, and any regulatory changes and best industry practices. Apprenticeships deepen that knowledge and provide the experiences that translate to expertise. Well-trained employees do not simply follow procedures, but understand the procedures and can identify, or even anticipate, problems. They learn how to handle the processes they oversee, significantly reducing the risk of lost batches and disappointed customers.
Keys to success
A culture for learning and continuous improvement
Companies that invest in worker development will notice that a culture of learning creates employees who take pride in the quality of their work. Well-trained employees tend to take responsibility for and understand the underlying processes of a given task. They are also more likely to adopt customer goals and strive to exceed expectations.
Training and development programmes are fundamental to continuous improvement efforts, and training of employees should be regarded as a continuous process. Annual training should be planned to keep certain skills, such as proper documentation, top-of-mind, while periodic training in machine maintenance, for example, keeps processes running smoothly. In addition to formal staff training, methodologies like Lean Six Sigma are a means of promoting continuous improvement, especially at the managerial level.
Facilitating compliance
Formal training programmes that are well-documented help maintain compliance with regulatory requirements. As all employees performing certain functions must be qualified, quality assurance can monitor the qualification status of employees and easily demonstrate during an audit what workers were trained in what subject, and on what date. Enterprise resource systems such as SAP can be used to plan, record, and monitor training programmes, enabling supervisors to check qualification status of workers should a substitution need to be made. Training curriculum can be developed from a comprehensive list of required skills that are defined for each function. The type and frequency of training can be based on risk, taking into account the significance and potential impact of that function on product quality and regulatory compliance. GMP requirements should be incorporated into training.
Tap into employee enthusiasm
A good training program builds employees’ confidence in their performance and esteem for their employer. It taps into each employee’s internal desire for competence, personal progress, and satisfaction. Rottendorf found that training helps its employees link their individual progress to the company’s success and customer’s satisfaction. Ongoing learning and feedback are cultural norms that encourage employees to strive for a better understanding of the workings throughout the various facilities.
Proof that it’s working
It’s important to measure the effectiveness of training programs. Employees should be tested on subject matters to ensure they understand requirements, like documentation, as well as processes and technology. Passing these tests should be a requirement of qualification as an operator or technician. The effectiveness of training courses can be determined in several ways:
- Supervisor observation of trained workers—Is their skill level increasing? Are there fewer problems and better understanding?
- Quality results—Is there less need for rework of quality control results or environmental monitoring?
- Improved evaluations for batch record review--are there fewer complaints?
Good training programs tap into employees’ natural curiosity and desire for confidence and competence. It develops a strong alignment between workers and employers, for a collective commitment to the company’s success. This gives companies a competitive advantage, as employees possess a solid understanding of operations, are more satisfied with their jobs, and are less likely to leave.
References
Article Details
Pharmaceutical Technology Europe
Vol. 27, No. 12
Pages: 10–12
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发表于 2015-11-28 08:43:48
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