Are you inspecting your glassware for defects?
A company recently received this 483 observation:
…..Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Specifically, the effectiveness of laboratory glassware cleaning procedures and lifecycle related practices do not ensure adequately clean volumetric glassware employed for the quantitative analysis of regulated drug products. During the inspection we noted laboratory volumetric glassware (flasks) with etching, pitting, and residual compounds, including sharpie markings. These markings could be removed from the glassware by rubbing.
For more observations pertaining to laboratory controls see Issue 1022 available today. It also has observations pertaining to manufacturing controls, medical device controls and sterile manufacturing controls.