Every pharmaceutical manufacturer should have their consumer’s health at the top of their priority list. Well, hopefully.
The good manufacturing practices guidelines keep consumer health at the high end of the priority list by ensuring the quality of pharmaceutical products. Without these guidelines, medicines could be potentially toxic due to harmful or unbalanced ratios of chemicals that were unintentionally added. On the other hand, a product without the amount of medicine needed will not have the intended therapeutic effect.
So what are these good manufacturing practices guidelines – and how do they impact what’s needed for high-compliance IT support? The first step to complying with these regulations is understanding exactly what they mean.
An adulterated product is dirty, contains a harmful substance, uses a non-certified or non-permitted color additive, or is manufactured under unsanitary conditions. In order to be labeled as adulterated, a product only has to meet one of these criteria.
A misbranded product has misleading or false labeling, fails to state required information, or has a misleading container presentation. Just like adulterated products, a product only has to meet one of these criteria to be prohibited.
Let’s take a look at the guidelines to prevent your product from being labeled as adulterated or misbranded.
In order to follow good manufacturing practices guidelines, your building has to be in excellent condition. GMP wants to see a facility of appropriate size with enough room to store all necessary equipment in an orderly fashion. All utilities are well-maintained and the facility appears clean and orderly. Your personnel have safe working conditions with appropriate lighting and ventilation.
Don’t forget—you also need to have sanitary conditions including toilets, floor drainage, and a sewage system that satisfies employee needs and maintains sanitary operation of the facility.
All equipment used in the facility needs to be appropriately maintained and free of corrosion, dirt, and a buildup of sanitizing agents. All utensils, transfer piping, and cosmetic contact surfaces must be clean, well-maintained, and sanitized regularly to prevent the spread of dirt or unsafe substances. Keep in mind, in order to comply with good manufacturing practices, you also need to store equipment and utensils in a way that protects them from dust or contamination.
Your employees run your facility. You rely on them to act appropriately in the workplace and follow guideline regulations. The good manufacturing practices guidelines recognize this and include personnel training as a crucial part of the GMP guidelines. If your employees aren’t properly trained, then you aren’t in compliance.
All employees must wear the appropriate clothing to be working with the materials, including hair restraints, gloves, closed toed shoes, etc. Good manufacturing practices also include restricting food, drink, and tobacco consumption to appropriate areas away from the manufacturing process. This is important for both the safety of the consumer and your employees. The last thing you want is someone eating and ingesting potentially harmful chemicals because their food was contaminated. On the other hand, you also don’t want cigarette ashes in someone’s medicine.
Chemicals can be easily contaminated. Especially when making medicine for someone whose immune system could already be compromised, contaminated chemicals have the potential to be disastrous.
Good manufacturing practices includes storing and handling raw materials appropriately. This includes preventing contamination with microorganisms, other chemicals, and environmental elements like excessive heat or cold. All material containers must be closed, off the floor, and labeled thoroughly. In order to follow guidelines, test the quality of your raw materials regularly and properly process materials that have been contaminated.
How you run your business can have an effect on the quality of the goods you produce. If the process for making a cosmetic changes every time you do manufacture it, then you will not produce the same quality of product every time.
In order to follow good manufacturing practices production guidelines, weights of materials to be added to the final product are checked twice by two different people. Labels are pre-examined to avoid mislabeling and returned products are inspected for contamination or deterioration.
Even if you follow every guideline and your product has been of good quality in the past, it’s still important to test your final products for quality.
The good manufacturing practices guidelines require you to provide laboratory controls by testing the identity of raw materials. Samples of approved lots, raw materials, and finished products must also be retained for a set time period before discarding. The water supply must also be regularly tested and retained samples must be tested for microbial contamination.
Even if your raw materials are stored properly, contamination-free, and your finished products are tested with results of excellent quality, a labeling or record-keeping mistake could still make your finished products harmful to the consumer.
Good manufacturing practices require that records must be kept of raw materials, manufactured batches, test results and distribution. On top of the records, all products and materials must be labeled with both a principal display panel and an information panel.
Customer complaints must also be properly documented to provide a record of any reported injuries, products associated with injury, and any medical treatment involved.
When you need to be sure you comply with GMP guidelines, work with a managed service provider that knows good manufacturing practices. Swift Systems has the experience in the manufacturing industry that you need to help maintain the best records of production procedures, labeling, and documentation.
When you’re ready to work with an IT department for your manufacturing facility that can provide you with a secure network, reliable performance, and smooth documentation processes, get in touch with Swift Systems today.
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