In the process of supplying water to a boiler or a humidification generator for a stability chamber, comes the question of which type of water to use. In today’s cost sensitive environments comes the challenge to justify the need to pretreat water that is going to be boiled away. ...
Posts Tagged with PM
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...
BIOCOM’s LifeLines summer 2016
Have you seen BIOCOM’s LifeLines summer issue? See page 21. We are there! You can also get LifeLines at 2016 Bio International Convention.
Dear DM Recipients
Thank you for visiting our website. This post is to provide further information for you. Background At first, we Nagano Science come from Japan. In Japan, we started our business as a stability chamber manufacturer over 40 years ago. We have provided chamber repair, PM, (re-) calibration/qualification and sample storage...
FDA 483 Tips #2
Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection Related FDA483/Warning Letter Sub section M. On 06/24/10 a request was made for the last performance qualification for the (B) Walk-In Stability Chamber (25/60),...
FDA 483 Tips #1
Routine inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. Related FDA483/Warning Letter Subsection D. (A&B) No written procedure is approved by QA describing Preventative Maintenance tasks and their frequency for concerning monthly tasks for the walk-in RH...
PM Planning / 483
Preventative Maintenance (PM) should be based on a proactive process that looks at the overall health of a chamber. A robust protocol will help anticipate problems and outages by recording the health of all components. Execution of the PM protocol should be performed on a routine schedule that is...