In the process of achieving quality, there are a lot of principles that are supposed to be followed. Especially in the field of pharmaceuticals, the goal is to prevent any kind of faulty medication and to make sure that the product stays efficient throughout its lifetime. The amount of work that goes in medical manufacturing and packaging goes into waste if the product were to be contaminated in the machinery itself. Hence it is important for the producing organization to have clear set procedures to ensure the safety of patients.
Whenever a product, pharmaceutical or food, is manufactured, it requires a high level of checks on every point of passage. The medical product shall not be handled incorrectly, have uneven proportions or get contaminated within the packaging machinery or during transport. Supplying quality to the end consumer is the primary objective of a drug manufacturing company. So when it comes to medical manufacturing and packaging, there are certain manufacturing practices to be followed for machinery and workforce alike. It is not to be learnt in college, it is simply a set of practices noted down by every federal agency that regulates the food and drugs market. Here’s what you need to know:
What are Good Manufacturing Practices?
Good manufacturing practices (GMP) or current good manufacturing practices (cGMP) is a set of compliance rules that ensure that any pharmaceutical or medical product or device goes through a consistent regulation that keeps the quality of the goods intact, hence reducing the chance of harm to the consumers.
The pharmaceutical industry relies on persistent precision. Since the industry has the responsibility of serving the sick, it cannot have a single mistake in quality, composition and consistency. Because, if a patient takes a pill and ends up back in the hospital, the company is liable to a suit and will also lose its market reputation. Hence, all pharmaceutical products and devices are supposed to be manufactured with Good Manufacturing Practices that gives a way to consistency in quality.
GMP not only saves the manufacturers from making a terrible blunder but also gives confidence to the users that want to have faith in their medicines. It provides a certainty that each medical dose and packaging has the same ingredients in calculation and that no machinery or transport can meddle with it.
Many people believe that testing the medical product after production can ensure quality. Logically, however, the tests conducted on a batch of goods really keeps the rest of the product line in blind sight. So, the only way to ensure that the product going out of the facility is pristine, is by applying procedures and checklists along with a trained and accountable workforce.
The ‘P’ in GMP consists of pillars for good manufacturing practices that prevail in the industry. They include the most essential parts of manufacturing practices that build the confidence in manufacturers about their process. This ensures that all the products are under the compliance rules of regulatory bodies so that the manufacturers can be answerable to the inspectors. Let’s get to know the P’s that complete GMP-
People
The people that work under the manufacturing roof are an important part of the production. The workforce, all along the hierarchy, must have a clear set of roles and responsibilities down to every individual. It is important that every person carries their responsibility religiously, keeping in mind that the products they are making are needed to save lives and cure people. Every employee in the hierarchy, especially the ones working with the ingredients and machinery, shall be trained to perfection in following procedures. They shall be regularly assessed on their methods and performances to make sure the efficiency is retained.
Process and Procedure
Processes are a set of tasks that are needed to be performed in an order so that an input can be turned into an output. The order in which the tasks need to be carried out to complete a process is known as the procedure. A procedure needs to be followed in sync in order to make sure that the process is consistent and complete every time. In pharmaceutical manufacturing, both processes and procedures shall be noted down and there shall be a clear understanding among the staff to achieve the goals of manufacturing and continue standard operations of the business.
Premise and Provisions
Premise and provisions are the two most important factors of pharmaceutical manufacturing. The premise or the facility is where all your processes and procedures take place. A medical manufacturing or packaging facility cannot risk having contamination from handling or machinery. A proper cleaning regimen shall be followed. In every medical facility, wherever there is production or packaging, there has to be proper calibration methods in place for the machinery, which is the most important provision. The people shall have a well-defined procedure to take care of the premise and to work the provisions to achieve total sanitation and no contamination in the product. This will ensure the consistency in quality that every pharmaceutical manufacturer needs.
Products
All the pillars of GMP are made to reach the end result, which is consistency and quality in every dose or unit that is bought by the consumers at the counter. This responsibility of taking care of all the Ps shall be end-to-end in the organization so that every batch of raw materials and finished products that leave the facility is of top quality and are correctly handled in order. There shall be a defined and documented specification list for all the ingredients and their quantity added to the product. This ensures consistency throughout the batch.
All in all, the 5 important pillars of GMP are required to be in order. In every medical production facility, be it manufacturing the drugs, packaging it, managing people or machinery, GMP fundamentals shall always be followed so that the end consumer can be confident and safe while taking their medications or using a product. Since packaging is the most important part of keeping the product safe, the process has to be efficient and seamless. At Accupack Engineering, we ensure that your packaging is less complex and more time and cost efficient.
