What constitutes good training for employees engaged in pharmaceutical manufacturing? Many pharmaceutical companies think they know the answer: "We give our employees copies of the applicable SOPs to read, and they sign a form stating that they understand them." But reading a document is not the same as receiving training on a process or procedure.
In recent years, FDA has cited a growing number of pharmaceutical companies for deficiencies in their training programs - despite the fact they can produce volumes of signed records showing their employees have read the SOPs.1
While FDA compliance is critical for pharmaceutical companies, it is not the most important reason to have effective employee training programs. Every manufacturer should be concerned about training because it is an essential component of quality. In the demanding environment of pharmaceutical manufacturing, companies cannot maintain high-quality production without high-quality training. Just as every manufacturing process must be thoroughly tested and proven to deliver consistent results to maintain product quality, effective training programs are essential to ensure that employees have the knowledge and skills they need to perform their jobs.
An Effective Training System Despite the lack of specifics in the regulations, there are a number of common elements that should be present in any effective training program
Each of these elements plays an important role in the process of giving employees the training they need to do their jobs safely and correctly and also provide the necessary documentation to demonstrate that the training was performed properly.
cGMP Training for New Employees. Many new employees do not have experience in the pharmaceutical industry, so it is important to begin their training with an overview of cGMP basics and why these practices are vital to the welfare of the employee, the company, and the patients who will ultimately use the company's products. The course should include a discussion of the regulations (such as an introduction to Subparts A through K of 21 CFR 211) and the role of SOPs in maintaining quality in the pharmaceutical manufacturing environment. Although this course is especially important for those new to the industry, it should be mandatory for all new employees regardless of their previous experience. This training should occur as soon as possible after an employee joins the company - typically within the first week of employment - and should include a testing component to ensure that new employees understand the material.
Ongoing cGMP Curriculum. According to 21 CFR 211.25,
Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.2