cGMP vs GMP

GMP or Good Manufacturing Practices are a set of guidelines for processes and documentation that need to be followed to ensure a high-quality product. NSF International provides 3^rd party certification that a manufacturer meets the GMP requirements. NSF’s GMP program started in 2002 in accordance with FDA 21 CFR Part 111 regulations that govern manufacturing, packaging and distributing dietary supplements in particular. In simple terms, being certified by NSF means that NSF International feels a manufacturer meets the standards of quality and safety required of their sealed approval. Good Manufacturing Practices or GMPs are not applicable to the manufacturers of dietary supplements only. The guidelines are applicable for companies involved in manufacturing raw materials, packaging, warehousing and distribution as well.

Regardless of the industry, it is important to provide the highest quality to consumers. There are a number of regulatory bodies that ensure compliance with the guidelines and standards that protect consumers. GMPs were created, and are also updated by the FDA in the USA. Often, people use GMP and cGMP interchangeably; however, there are some differences between the two. This article will proceed to discuss cGMP vs GMP certifications.

What is GMP? 

As stated earlier, GMP means Good Manufacturing Practices and is implemented by the FDA. The guidelines are in place for the companies involved in the entire manufacturing process, from raw materials to storage and transport, of food items, drugs and medical devices. Following these practices ensures that the end product is completely safe for human use and consumption. It also means that the products are efficacious and pure, without any errors or contaminations. In addition to processes, GMP also applies to the involved buildings and facilities, staff and pieces of equipment.

GMP registration with NSF ensures that the supplements have been manufactured in a facility that had proper equipment, processes and controls in place to manufacture supplements that are in compliance with the FDA regulations. However, it is important to know that GMP registration and Gmp Certification are not the same. GMP registration does not involve testing and verifying the final product itself. A product with GMP certification will have a certification mark on the product’s label.

What is cGMP?

cGMP is used to refer to the ‘Current Good Manufacturing Practices’. The “c” in GMP just means current.  The regulations require that manufacturers follow Good Manufacturing Practices.  The “current” in front of that just acknowledges that what is considered ‘good changes’ over time.  Each year the FDA expects companies to continually improve the standards of their facilities. Using the latest, state-of-the-art technologies and software also help manufacturers in producing supplements efficiently at a massive scale. However, the guidelines (while leaving most of the decisions up to the manufacturers) still require the manufacturers to provide internal systems that assist with organization and accountability. They can independently choose the technology, processes, and software they deem fit for their products.

Acquiring cGMP certification means investing in state-of-the-art equipment and technology in addition to the certification costs. cGMP is widely recognized across the globe. Another important factor to consider is that innovative technologies and testing techniques result in higher quality and greater purity. cGMP provides modern quality assurance techniques.

cGMP vs GMP Certification: Which one to choose?

As a supplement provider, you may be confused about which one of the two, cGMP vs GMP certification, is better for your business. While GMP is the standard, cGMP certification ensures that the facility, as well as all the other aspects of supplement manufacturing, are up-to-date and not obsolete. The manufacturing, testing and storing facilities, and technologies adhering to GMP may have been the best options about two decades ago, but the latest advancements have made it possible to achieve an even greater level of quality, purity, and effectiveness. Choosing a manufacturer that is cGMP certified can help suppliers leverage the latest available technology to their benefit.

The post cGMP vs Gmp Certification Explained in 2019 appeared first on Ion Labs.