Wednesday, August 17, 2016

Warning Letter of the Week: R&D folder edition

Via Pharmaceutical Manufacturing, an interesting warning letter to Zhejiang Medicine: 
Your laboratory personnel conducted unofficial testing without appropriate documentation, justification, and investigation.

Our inspection found that analysts performed multiple gas chromatography (GC) analyses of [redacted] samples for residual solvents. Analysts performed these unofficial analyses and recorded them in separate “R&D” folders before conducting the officially reported sample analyses. The original, unofficial analyses stored in separate R&D folders were not part of the official quality control records for your API, and your firm did not consider the results of these unofficial analyses to evaluate the quality of your API or make batch release decisions for numerous batches of API.

Our investigator reviewed chromatograms found in the R&D folders and noted that some displayed large unknown peaks that were not reported in the official records for the same samples. The presence of such peaks in the chromatograms may indicate the presence of unknown and uncharacterized impurities (including potential contaminants) in your drugs. 
That folder of data? Oh, that's nothing, don't worry about it.

A pleasant little tidbit: Zhejiang Medicine is responsible for supplying vancomycin API to Pfizer's Hospira unit. (via the South China Morning Post.) I'm sure they're fully compliant with cGMP with vanco, though. 


  1. Some friendly advice to Zhejiang Medicine: In order for the file drawer effect to work, the folder needs to actually be in a file drawer.

  2. Either you get killed by Vancomycin resistant bacteria or contaminated Vancomycin. Chose your poison!