Spreadsheets are Error Prone and Pose Problems for Companies in the Life Sciences Industry Today
GMP Training - Are You Watching it as Closely as the FDA Requires?
Reasons for a Heightened Focus on Training and Quality Control
Training programs are under the FDA’s microscope because insufficient employee training has been identified as a root cause of defects. Additionally, the changing composition of the manufacturing workforce has resulted in an overall lower level of experience among production employees. As layoffs continue to occur and seasoned employees approach retirement age, the following changes have resulted:
- A loss of experienced employees
- A growing percentage of contract workers
- An influx of new hires with little work experience
It is not easy for companies to compensate for this loss of manufacturing expertise, especially as companies feel pressured to reduce spending across the board. Bolstering training and educationprograms therefore becomes a necessity for companies seeking to maintain quality production.
How to Strengthen Your Company’s Training and Educational Initiatives
With the FDA’s increased focus on employee training, it is imperative that companies devote attention to improving their employee
Trouble with your Training Matrix?
Most companies face trouble with their training matrix because employees are unable to track the individual SOPs they need to follow, management is unable to interactively train employees, and the entire system tends to get lost in the mix. This is often caused because Excel or limited database-managed systems have over 100,000 entries. These entries are difficult to search and track and cost users time and energy just to guarantee that they have fulfilled training
An increasingly critical part of GMP training is to ensure that every company employee has received sufficient education and training regarding key processes in the manufacturing of a product. Companies must also provide detailed documentation regarding the scope of training programs and dates of completion for training modules. Failure to provide detailed evidence of employee training programs may result in warning letters or sanctions by the FDA.
The FDA's Increased Focus on Training Programs
In recent years, the FDA has devoted increased attention to the review of training records and quality control procedures. With manufacturing problems frequently being linked to improperly trained personnel, the FDA has identified training as an area that requires sustained focus. Training programs have become increasingly important over the past decade as companies lose seasoned employees due to retirement or layoffs. When a company is staffed primarily by contract workers and new hires, effective training becomes critical because a smaller percentage of employees have a long working historywith pharmaceutical products. Companies that have reduced their training budgets or plan to do so in the near future should proceed with caution.
Measures to Improve Your Company’s Employee Training Program
In the world of FDA investigations, a verbal acknowledgement of the existence of an employee training program is not sufficient. FDA
Pharmaceutical firms cannot have any errors in the manufacturing process. One process or supply error can contaminate an entire production cycle. At the same time, the government has strict standards on the manufacturing process that must be followed. Violating these can result in fines or production halts. To avoid these issues, companies create Good Manufacturing Practices (GMP) and put in place stringent training. GMP training is important to the FDA and helps the company achieve a high level of performance and quality.
In fact, companies must be aware of stepped up actions by the FDA to protect consumers. The FDA questions the training and production of chemical products by employees at every step in the process. For example, the FDA recently warned a cosmetics company because a single chemist in its R&D facility did not have the necessary training on microbial limits to prevent critical errors. The FDA continues to issue more
Trouble with your Training Matrix?
Pharmaceutical companies use large training matrices to track employee's proficiency on SOPs, manufacturing processes, quality controls, and product reviews. When these training matrices are out of order, inefficient for employees, and do not deliver the right information to management, they cause multiple problems.
These seven problems are symptoms that your company's system needs to be updated and upgraded in order to maintain high quality product delivery. How many of these signs is your organization suffering from?1. Human Entry Errors
Trouble with a training matrix occurs when people enter information regarding SOP training, or in the entry of other information they should have been trained on. Statistically predictable variations in quality information are almost always a result of management systems.
GMP training remains a necessity in the pharmaceutical industry to keep products in line with FDA compliance. However, many employees who have to hear about Good Manufacturing Practices have little enthusiasm for it, especially because it has to occur at least once a year. The reasoning behind this low opinion comes from recent emerging incidents.
About six years ago, concerns developed about how bad GMP training had become in many pharma industries. The FDA even sent out a warning
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Perhaps the biggest challenge facing a quality management team today, especially in the Life Sciences, is how to comply with regulations and take advantage of new cost-saving opportunities when the regulatory environment is fluid.
Maybe it’s time to do some Monday morning quarterbacking to see how your quality management system can grab every opportunity to regain possession of the ball. You may find that the true cost of your paper-based quality management system is ready for a game-changer.
Pivoting to comply or capture a new opportunity
In a recent “Monday Morning Regulatory Review,” the Federal Regulations Advisor reports that “the United States Court of Appeals for the Second Circuit held that the Department of Health and Human Services (HHS) 2000 regulation barring certain hospital reclassifications violated the plain terms of the Medicare Act and, therefore, was invalid….” As a result, HHS is now under some pressure to review its reclassification system for the purpose of reimbursement under the Medicare Act.
Consider the steps you have to take now, with your company’s current paper-based quality management system, to comply with a new regulation.
- Depending on the extent to which a new regulation alters the field, pivoting may require your calling a great number of “time-outs” from the routine workflow to comply or to take advantage of a new opportunity.