SOP for general visual inspection procedure for commercial product
SOP-0888
Critical reject defined by a shadow
CRK
Ultra-low 2mL product
BioEQ
FRM # for inspection forms of vials
FRM-1209
Clinical Part numbers include? (EX: Commerical = X-CO-XXXX)
FF
SOP for visual inspection of vials
SOP-0787
Major B reject defined as product in center/upper groove of stopper
PRD
Product that undergoes incubation
Media
FRM # for inspection forms of syringes
FRM-1210
T/F: You can wear earrings in offload as long as your bouffant covers your ears
False
SOP for visual inspection of syringes
SOP-0788
DCP
Botox cakes
LYO/Revance
FRM # for pre-inspection steps
FRM-1768
T/F: Partial cross outs are permitted for corrections if only some of the information is incorrect
False
SOP for visual inspection of media
SOP-0789
Minor reject defined as seal or cap discoloration
Product that contains opaque liquid
Alnylam
Sample Breakdown FRM#
FRM-1254
2000
SOP for Good Documentation Practice
SOP-0086
MLT
Product characterized as yellow, only comes in syringes
Glaukos
Acceptable Chain of Custody FRM
FRM-0483
How many minutes between eye rests PER SOP?
30 minutes