First GMP role and things seem off
Im a new addition to a QC team at a small pharma company. There's been a lot of turnover and morale is generally pretty low.
The company's SOP for analyzing their API is the USP HPLC method exactly. The method runs for 45 min and their equilibration/system suitability takes so long that they run it the day before. One time, QC got delayed for an in-line process during a production and material was released so late that the manufacturing team ended up staying to work until midnight.
Theyre reluctant to make changes and revalidate their SOP, even though I strongly think the company would benefit from it. I dont feel like there is a reason for the long method because their chromatograph only shows one peak, the analyte. Theyre also injecting such dilute material that the max peak height is only 60-120 mAU. If degradation/adulterants were present im not even sure they would detect them.
Whats also weird is that no one knows what the drug composition actual is. We know its a nanoparticle formulation and the manufacturing team knows the excipients but the actual composition of the particle is "proprietary".
Can anyone with GMP experience give me their take?
Posted Jul 9, 2025, 4:14 AM UTC