GMP News - APIs and Excipients

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.

The answer to this question is: It depends. Recently, medical cannabis grown in a non-EU-GMP-certified facility in Uruguay became available on the German market.

The new FDA Guidance for industry reflects the current state of knowledge regarding nitrosamine impurities. Read more here about what measures the FDA expects from medicinal products and API manufacturers to take to mitigate the risk of nitrosamine contamination.

This is now also possible for ASMFs and the procedure is clearly described in the updated Q&A document of the CMDh.

Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.