iso gmp

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) ISO Certification

Good Manufacturing Practices (GMPs) describe the rules and regulations for the processes by which pharmaceuticals are made. They determine what needs to be done to achieve quality when manufacturing these products. The Food and Drug Administration will pursue companies that do not have proper GMPs in place. This is why it’s important to hire an experienced ISO consultant to help with this process.

About Our Experienced GMP Consulting Firm
Good Manufacturing Practice is one of the areas of expertise for Michael Madewell. He’s been consulting for over 15 years and has led over 300 companies to success in this area. He shows companies how to adhere to the regulations to achieve the identity, quality, strength, and purity of the products. He helps companies establish “strong quality management systems” and establish robust operating systems. He also teaches them how to obtain the appropriate raw materials and how to detect and investigate product quality deviations. He is skilled in these areas and other areas. Here are some other ways that he can help you.

Help You Prevent Adverse Instances
With pharmaceutical companies, it’s easy to have instances of contamination, deviations, and mix-ups, which leads to failures and errors. When he helps companies achieve quality standards, he can help them pass their audits with little or no difficulty. Companies will learn to use modern technologies to achieve higher quality through continual improvement. Errors can be reduced by as much as 10 to 20 less with the methodologies he uses.

GMP ISO Certification Helps You Reduce Lawsuits
If you obtain your GMP certification, it can help you avoid lawsuits. Because a consumer usually cannot determine if a pharmaceutical is defective through smell, touch, or sight, there needs to be processes in place that will ensure quality. He teaches companies how to maximize the testing on the small batches of tablets. Typically, 100 out of two million tablets are tested to ensure that the batch is good. Our consultant infuses quality at every step to ensure that a quality product is yielded. This may mean ensuring that the equipment is calibrated and maintained properly. The processes should also be reliable, and he will work with your organization until they are not only reliable but also reproducible.

Trains Employees on GMP Rules and Regulations
If employees are not aware of the GMP rules and regulations, they will not know how to achieve the goals necessary to pass the audit on the first time. That’s why it’s important to train and inform employees. Reports of each site will be administered to the Food and Drug Administration. If your site is in need of inspection or investigation, they’ll be the first to know. He will help you pass your inspection to keep your certification in good standing.

Good Manufacturing Practice (GMP) is Necessary for Drug Manufacturers
GMPs are necessary for drug manufacturers who want to avoid production of defective products. These products may or may not be safe for human consumption. If they are not safe for human consumption, they may harm consumers. Companies need to avoid lawsuits that can irreparably harm their income. Our GMP consulting firm can help you achieve these goals.

ISOReady can provide a turn-key solution to Good Manufacturing Practice compliance utilizing state funding to offset the cost. We also offer ISO certification and consulting services.