1. ARE YOU IN COMPLIANCE OR
‘THINK’ YOU ARE IN COMPLIANCE ?
The GMP’s Guidelines state in Q7 GMP Section E (11.5) paragraph 3: Stability samples should be stored in
containers that simulate the market container. For example, if the API is marketed in bags within fiber drums,
stability samples can be packaged in bags of the same material and in small-scale drums of similar or identical
material composition to the market drums.
STABILITY WARNING
QUALITY SERVICE PRODUCTS
528 East Hudson Street, Columbus, Ohio 43202
Ph: 614.447.9522 Fx: 614.263.1478 ssbqsp@yahoo.com
QSP’s HMW-HDPE stability sample
bottles use EXACT materials and
colors as plastic drums, thereby
eliminating expensive qualification
testing costs
GP-HDPE Natural bottles
Glass containers
QSP’s HMW-HDPE stability sample
bottles use EXACT materials and
additives as IBC’s (totes), thereby
eliminating expensive qualification
testing costs
GP-HDPE Natural (No UV
additive) bottles
If you ship and store in drums and IBC’s (totes) but retain stability samples in
generic HDPE or glass you risk non-compliance. For the first time small-scale
containers are available in drum and IBC material!