Maintaining high product quality requires a series of actions and strategies to ensure all products released to the public are safe and adhere to regulatory guidelines. Following Good Manufacturing Practice (GMP) remains a priority for pharmaceutical industry players who want to comply with evolving regulations in the industry. Below, we share what players in this industry need to know about GMP and what they should consider while ensuring quality products and devices. Is Personalized medicine the future of the pharmaceutical industry? Read to know more on this.
Understanding Good Manufacturing Practice (GMP)
GMP sets forth the minimum quality standards that product manufacturers have to meet to ensure users of products and devices are not harmed. A common way of doing this is preventing adulteration and contamination of pharmaceutical products by ensuring a high level of quality control is present throughout the manufacturing process.
With the overarching priority being the safety of users, each pharmaceutical company has to define and implement the best manufacturing practices depending on how it interprets and implements good manufacturing practices.
Provide procedures and working instructions
The importance of written procedures cannot be understated when talking about the safety of thousands and potentially millions of users of certain medications and products. Having well-written and transparent procedures and instructions on ensuring high-quality standards and following them is one of the best ways to remain GMP compliant.
Written procedures minimize the chances of mix-ups, misunderstandings, and manufacturing errors that can cost the company a lot of time and money and put users at risk.
Validation of processes
Documentation and validation are essential in pharmaceutical manufacturing processes and go hand in hand. At the fundamental level, employees should document all the steps they take from the start to the end of manufacturing a specific product. This is so that they can produce accurate documentation promptly should be required according to written guidelines.
Documentation proves that employees have done everything according to procedures, but this needs to be validated. Validation is done using proactive proof. It requires a series of tests to ensure all processes and systems are working as expected, with the results of the tests providing the validation evidence required.
Validation gives documentation meaning and assures stakeholders that all written procedures are correct and followed during the manufacture of specific products.
Making cleanliness a requirement
Another way to ensure quality products is to incorporate cleaning practices among employees. Contamination is a serious issue, especially in companies that manufacture more than one product, as noted by the Brisbane dust excavation service experts.
These companies must be aware of three main types of contamination: particulate, microbial, and cross-contamination. These are contamination by particles that do not belong, microbes, and impurities.
While there are many ways to reduce each type of contamination, one practice used a lot in pharmaceutical industries with a lot of success is clean-in-place (CIP). This is a cleaning method used in pharmaceutical industries to clean process equipment, filters, fittings, pipes, and other equipment without disassembling them.
The water used in this cleaning process must be of the same quality as that used in the manufacturing process and must be sealed from any contact with the environment. One way of doing this is through transfer panels that direct fluid flow in different areas to be cleaned with a break in the flow, unintentional mixing, or sending the wrong fluid down the wrong line.
Pharmaceutical companies can contract stainless steel custom fabricators to design transfer panels that are an effective and more effective solution to options already available on the market.
Ensuring employees practice good hygiene
Apart from the manufacturing process and inadequate cleaning, contamination can also be introduced by employees working on different lines. The hygiene among employees becomes very important as it eliminates the introduction of the three types of contamination we have discussed above.
Additionally, employees trained in good hygiene practices are more likely to report conditions, equipment, and practices that can lead to contamination because they can more easily recognize them.
Hiring the right people
How well GMPs are followed depends on the people a pharmaceutical company hires. These people should not only be competent enough to manufacture the products they are required to but also follow quality practices.
The right type of people to hire for these types of positions is those who can do the job the right way the first time and every time they are expected to. This means they must understand their responsibility to develop, demonstrate, and continually improve their job competence.
Even in cases where a pharmaceutical company hires the right people, it has to train them, especially in quality control inside the manufacturing process. The right people will be able to pick up the training faster, saving the company time and money.
Quality management
Quality management is a significant part of ensuring GMPs are followed, and it cuts across the manufacturing process. It starts with ensuring the materials sourced meet quality standards. Next, the manufacturing process must be assessed to ensure it does not lead to a breakdown in following proper GMPs. Labels, packaging, and testing can result in unsafe products.
Ensuring Good Manufacturing Practice (GMP) is critical in the pharmaceutical industry, where people’s lives are on the line. Fortunately, the guidelines and rules required to do so are only available with what remains to be how different companies implement them.
