Importance Of CGMP In Manufacturing

5.1 Importance of CGMP in Manufacturing

5.1.1 What is CGMP?

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This

The average consumer cannot, either by sight, smell or touch, detect whether food, drug or cosmetic products are safe and/or effective. One part of determining this is testing products at various stages of production, but this alone cannot sufficiently ensure quality. This is because testing is carried out on a rather small batch of products (such as a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets). This way, majority of the products can be used for patients rather than sacrificing them to test procedures.

As such, it is important to have guidelines/regulations governing every step, process, facility or equipment that will be used in the design and manufacture of consumer products. Facilities must be maintained in good condition, good clinical practice should be followed, employees should be properly trained and qualified, validation and verification of equipment should be done to maintain accurate, verified and calibrated measurements and processes should be consistent and

In fact, GMP’s, called Goods Manufacturing Practices, have become guidelines that have helped maintain standards in these products across the world. Countries following GMP ensure quality of pharmaceutical products so that these products can be relied upon by people all over the world.

Slowly and gradually, GMP’s have become a pre requisite to export healthcare products between more than 100 countries of the world. It has become a trend to refer to GMP as CGMP. Here, C refers to current rules and regulations that serve the purpose of reminding manufacturers to strictly follow the guidelines and manufacturing procedures that are current and most up to