As mfg evolves, quality control must adapt

IN the pharmaceutical industry, the quality of raw materials especially active pharmaceutical ingredients (APIs) and excipients is what makes medicines safe, effective and trustworthy.

- ASHLY MERIN GEORGE

In the last 10 years, quality control of these materials has gone from being a technical requirement to a strategic priority that protects patients’ health, avoids expensive recalls and makes sure that international rules are followed. A single drop in the quality of an API or excipient can hurt therapeutic outcomes, put patients at risk and lead to fines from regulators. To avoid these kinds of problems, drug companies follow strict rules for sourcing, testing, documenting and monitoring, based on global standards like ICH Q7 and WHO GMP. They are also closely watched by regulatory bodies like the U.S. FDA, EMA and Indian CDSCO.

Sources and Types of Raw Materials for Pharmaceuticals

Pharmaceutical raw materials come from many different places and are grouped together to make it easier to check their quality and make sure they follow the rules. There are three main types based on sources:

Natural sources: These materials come from plants, animals or minerals and have been used for hundreds of years. However, natural variability and the possibility of contamination make strict standardisation and quality checks necessary.

Synthetic sources: Synthetic APIs and excipients are the most common types of pharmaceuticals today because they can be made repeatedly which are stable and can be produced in large quantities. They make it possible to prepare pure compounds that are exact copies of or better than natural substances.

Biotechnological sources: These materials come from living things like genetically modified bacteria, yeast or cultured mammalian cells. They are becoming more important in biologics and biosimilars. Because they are complex, they need advanced quality control systems to stay stable and avoid contamination.

Pharmaceutical raw materials are split into two groups: