News

In the pharmaceutical industry, the management of impurities - in particular, control via suitable analytical methods and reporting requirements - is clearly regulated. The main requirements are set out in the ICH Q3B(R2) guideline. What are the requirements for testing for impurities in the pharmaceutical industry?

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturing facility in South Korea, illustrating how missing method validation can rapidly escalate from a QC topic to a broader compliance, supply, and market-access issue.

In both the EU and the US, it is illegal to place a medicinal product on the market without a marketing authorisation. This raises the question: What do you need to know from a GMP perspective about medicinal product authorisations in the EU and the US?

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an EU-based OTC drug manufacturer (Czech Republic) after reviewing documents submitted after a request for records and other information. Key findings include missing incoming material identity testing, no stability program despite labeled expiry dates, inadequate process validation, insufficient method validation and microbiological control, and incomplete laboratory documentation.