Ever heard of a pharma company ignoring the current Good Manufacturing Practices (cGMPs) and doing well in its business? I know and you too, that this cannot be true in any case. Then how can it do well? You are right! By following the cGMPs. Most countries have legislated GMP processes for manufacturing entities to ensure the quality of medicines so that patient health is safeguarded. Any manufacturer who fails to comply with the prescribed standards has to face consequences such as the cancellation of license, ban on products, or penalties for being non-compliant with cGMP.
According to a CGMP case study published by the Food and Drug Administration (FDA), investigators observed a pre-compression practice during a routine FDA inspection and found insufficient release testing and issued a warning letter to the manufacturer for a deficient process validation. Hope you realize how important it is to comply with the cGMP standards. Traditional classroom training may not prove effective to train your employees on cGMP, so you can try using various online instructional design strategies for training.
Use game-based learning for best practices in manufacturing
To avoid any violation of cGMPs, you need to train your employees on the best practices of pharmaceutical manufacturing. Every step of the manufacturing process demands the best practices. For instance, assume you want to train them on the best practices to be followed under ‘buildings and facilities’, then you can design a game-based course that asks them to choose all the correct procedures to be followed such as the raw materials to be stored in quarantine, rejected material to be separated, buildings to be maintained pest-free, adequate lighting in the building, etc. They score points, badges, and trophies for each correct answer at every level they clear. The game elements keep them engaged and the leaderboard keeps them motivated as they want to beat their peer scores and stay on top.
Go for scenario-based learning for teaching them right and wrong
When you want to educate your workforce on what to follow and what not to, scenario-based learning seems to be one of the best options. A scenario-based course places the learner amidst a scenario that compels him to think and act. He has to take certain decisions that are going to impact his course of action in the given scenario. He selects what he thinks is right and faces the consequences. In case his decision is right, he is appreciated and receives a feedback stating why he was right. Even if he makes a wrong choice, he receives feedback on why his choice was wrong.
Imagine you want to teach your employees laboratory maintenance, you can show them a scenario where the laboratory is disorganized. You can then ask them to identify what changes need to be made so that the laboratory turns out to be an ideal place for carrying out procedures such as sampling plans, test procedures, stability testing, etc.
Employ microlearning for new or updated Standard Operating Procedures (SOPs)
Microlearning, as known, is a learning technique that provides just-in-time information to learners at the right time. This learning approach imparts knowledge in short bites so that the learners stay engaged through the course. It also helps knowledge stick to the learner longer due to its success in holding the learner’s short attention span. The SOPs of any cGMP process are mandatory for all your employees as they need to follow the apt procedure to get the desired end results. The sole purpose of an SOP is to ensure important jobs are performed appropriately, consistently, and in sync with approved procedures. There are various SOPs to be followed by every employee. For instance, one of the SOPs an employee requires to know is the standards or stipulations, testing methods, cleaning and sterilizing methods, processing methods so that the pyrogenic properties are removed for drug containers and closures. Such SOPs can be easily taught through microlearning modules that deliver the intended knowledge without overloading learners. Similarly, any change in the SOPs can also be swiftly updated through microlearning modules as they can be revised in no time.
Hence, a combination of games, scenarios, and microlearning modules can go far in teaching your employees the current good manufacturing practices. They help them understand the relevance of cGMPs and how the practice of cGMPs leads to compliance with the standards set by the Food and Drug administration (FDA) and other regulatory authorities. So, following cGMPs will help your organization avoid any sort of violations and deliver better to your clients. This aids your organization in staying compliant and you can avoid facing the consequences you may have to, in case you violate the rules and regulations.
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