A & C Your Global GMP Partner

GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined  under FDA 21 C FR  Pa rt 2 10-211.   The first set of Good Manufacturing Practices (GMP) or custom manufacturing regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.   In this blog, we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.   Trained inspectors for the FDA examine facilities around the world, inclu...

GMP Packaging Can Benefit to Your Business GMP  packaging is a science and it involves making sure that the components of your products are safe. The goal is to make sure that a product doesn't cause harm or even danger to your customers. Therefore, the whole process is important to ensure that you have your packages come out the way that you want them to and they will be well-received by your customers.   The process involves a lot of science, so it is very important that you get the products right. You need to get your products made correctly so that the packaging comes out perfectly. You need to make sure that the packaging is right and makes the products safe for consumption. The benefits of this can be felt in a lot of different ways.   Several Benefits of GMP Packaging to your Business First of all, using GMP packaging can greatly reduce the risk of health hazards in your products. These can include things like lead poisoning and just general quality of fo...

If you are a manufacturer getting ready for an FDA inspection to be an FDA registered manufactures , what is the first thing you should do? First of all, you must have a fair understanding of how the FDA functions. It includes the processes and systems involved with an FDA inspection. FDA offers relevant study material, guides, and manuals for you to understand its requirements and processes. In this article, we will discuss the study material and training you need to successfully pass their FDA inspection or audit. Authentic and Updated Information You can always refer to the official website of FDA, fda.gov for any information you need about FDA processes. For example, you may refer to the Regulatory Procedures Manual (RPM) on the official website of the FDA to know more about internal FDA procedures. For additional information on this subject, you can refer to the Compliance Policy Guide (CPG). If you want to know the processes and requirements for FDA, you can refer to Inves...