Making sure APIs made & controlled in consistent way

THERE are a lot of rules, methods, and quality systems that make sure active pharmaceutical ingredients (APIs) are safe, effective, and meet international pharmacopeial and regulatory standards.

- N SUNANDA

These rules are called Current Good Manufacturing Practices (cGMP). Because APIs have a direct impact on the safety and effectiveness of finished medical products given to patients, they need to be closely monitored for quality. APIs are the main active ingredients in pharmaceutical drugs.

An Overview of cGMP and Why It's Important in API Manufacturing:

The idea of "current" is part of cGMP, a new way of thinking about Good Manufacturing Practices (GMP) that focusses on using new technologies, scientific discoveries, and quality risk management methods. The main goal of cGMP is to set up a system that makes sure APIs are made and controlled in a consistent way that meets certain quality standards. This system also lowers the risks of contamination, mix-ups, and deviations during the manufacturing process.

Manufacturing under cGMP conditions covers every important step, from getting and handling raw materials and starting materials to synthesis, isolation, purification, and physical processing, as well as packing, labelling, storing, and shipping. It also includes intermediates and in-process quality control to make sure that the quality and safety profiles stay the same at all times.

Following cGMP makes sure that APIs meet the set standards for identification, purity, strength, and quality. All of these things are important for making sure that patients are safe and that the treatment works. The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), and the International Council for Harmonisation (ICH) have all made cGMP requirements official through guidance documents like ICH Q7, the FDA Code of Federal Regulations (21 CFR parts), and WHO GMP guidelines.

Important Parts of cGMP for APIs

1. Quality Management System (QMS)