As the world tries to get back to some semblance of normalcy after the coronavirus pandemic, pharmaceutical, biotech and med device companies are anticipating the day when the FDA returns to normal operations and begins conducting inspections. The backlog of inspections is insurmountable but don’t let this fool you. Your inspection could be soon!
As companies scramble to get projects back on track and inspection-ready, one area that may be easily forgotten is employee training. According to the FDA, training should occur “on a continuing basis and with sufficient frequency to assure that employees remain familiar with GMP requirements applicable to them.” To meet this requirement, maintaining a GMP workforce culture is critical.
In this blog post, we’ll share with you the importance of a compliant workforce and the most efficient and effective way to create and maintain one.
An important part of engaging employees is providing them with proper training. Many companies conduct GMP training when new employees are hired and then once a year thereafter. Unfortunately, many employees never hear about GMP again.
A once-a-year training structure has the potential to become problematic during an FDA inspection as inspectors will ask employees GMP-related questions. Will your employees remember the answers if they only hear about GMP once a year? When employees have to learn GMPs all at once, they get overwhelmed and don’t retain the information. Frequent, brief trainings on various parts of GMP throughout the year reinforce the initial training session and can foster a GMP compliant workforce.
FDA regulations require that anyone involved in the manufacturing, processing, packing, and holding of a product – including anyone who supervises these processes – needs education, training, and experience to perform their assigned functions. These individuals also need training on general GMP requirements, particularly those related to their job functions.
With that said, expanding training to those not directly involved in the manufacturing process, such as upper management, IT, and other support staff, helps foster a GMP mindset across the organization.
In accordance with the FDA’s guidance to train on a continuing basis, it is critical to develop and implement a year-round GMP training schedule to include:
GMP training must prepare employees to work in a GMP environment. To fill this need, training should cover basic elements of this environment, as well as how regulations relate to specific job functions. Training topics should include:
Employees should refresh their training regularly to reinforce previous training, and to stay current on new updates as these happen regularly in the pharmaceutical industry. Additionally, a great time for a refresher training is in preparation for an impending FDA inspection.
The challenge to GMP training is the implementation. Efficiency is necessary when there are a large number of people involved in the GMP-related activities. The objective of compliance instruction is to provide GMP know-how to the employees who have to use GMP for their daily work. Usually, department-specific training courses are carried out by a technical supervisor or a training representative who has professional experience and qualifications.
In the event employees cannot take part in a training course on a planned date, they must be trained within a reasonable time period. Organizing an additional training session for 1-5 employees can be time-consuming and costly. In this instance, on-demand training is a great alternative as it can be accessed at any time, from any location, and is a cost-effective training method used by companies large and small. The most widely used on-demand training is typically based on real-world experience and applications.
While the results of internal and customer audits are not available to the public, the 483 observations made during an inspection by an FDA representative are made public. Manufacturers who receive 483s are at a great disadvantage when it comes to competing for business. Anyone, including competitors, can locate a company’s inspection report online and use it as a marketing or sales tool when pitching new business. It’s an easy choice to make when choosing between a manufacturer who has received 483s versus one who has not.
The best way to prepare for an FDA inspection is to hire a third-party to conduct a mock inspection. This is also an excellent way to keep employees engaged and on their toes. Regular audits can reinforce a GMP culture at the manufacturer and make checks on GMP compliance more routine rather than something that gets checked every once in a while, or only when something goes wrong.
Creating a GMP culture is not easy. It takes a collective, consistent effort to comply with GMPs and to safeguard it against expediency, customer demands, employee indifference of anxiety, and economic pressures. A GMP culture can give employees assurance that they can rely on each other to do the right thing. Perhaps there is no better reason to enforce a GMP culture than the fact that patient’s health and safety relies on manufacturers passing FDA inspections and employees always doing the right thing.
ProPharma Group provides on-demand GMP training by industry experts. The training is accessible free of charge, 24/7/365. To learn more or register, click here.
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