When All is Said and Done, there is More Said than Done

I couldn’t help but contrast the claims made by NexgenPharma on their website¹ with the responses to observations cited in the recent FDA Warning Letter about their operation.²

Website: Each pharmaceutical product undergoes rigid process validation…

Observation: Your firm has not conducted adequate cleaning validation or provided scientific justification.

Response: We’ve done it this way for the past [redacted].

Website: We test and analyze raw materials, products in production and finished goods using advanced analytical techniques…

Observation: Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance…including the identity and strength of each active, prior to release.

Response: …are closely related in structure and thus, do not necessitate individual testing for strength…We will test each drug product component at least once a year…

Website: Each pharmaceutical product undergoes rigid… stability…

Observation: Your firm does not have a written testing program designed to assess the stability characteristics of drug products…

Response: …stability studies are only performed if the customer pays to conduct the studies…(we) rely on stability data recorded in the years before and after to support the label expiry…

Website: Nexgen adheres to the strict standards of the current Good Manufacturing Practices (CGMPs) established by the US Food and Drug Administration…

Observation: …we remind you of your responsibility for ensuring that your firm’s drug manufacturing operations comply with applicable requirements, including the CGMP regulations. FDA expects NexgenPharma, Inc. to undertake a comprehensive and global assessment of your manufacturing operations to ensure that drug products conform to FDA requirements.

Response: None. (What can possibly be said after that?)

It’s a really impressive website. But it reminds me of the adage: “An ounce of image is worth a pound of performance.” On behalf of all the patients dependent upon their performance, good luck.

The QA Pharm

¹ http://www.nexgenpharma.com

² http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm233276.htm