In the rush following the discovery of a malfunctioning chamber, some of the most important information may be missed. The 483 below identifies that some of the basic information for this outage was missed. The 483 doesn’t say what time the outage happened, but if it was...
Articles from August 2016
Stability Testing related News – Vol.2
◆ Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia (15-Jun-16 ECA) The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes. The first draft version had already been published in...
Operational Qualification (OQ)
The Operational Qualification (OQ) is the fourth document in the validation approval process for bringing a stability chamber online. The OQ testing is a verification that the unit was installed and operates as outlined in the Design Qualification. Figure 1 In the OQ, the testing is designed to have...