◆ New Details on the Revision of USP Chapter 1 (13-Apr-16 ECA) USP’s Chapter <1> “Injections and Implanted Drug Products (Parenterals)-Product Quality Tests’ has been revised again. New information is now available. The USP published these details on 25 March. The revised version now contains a table...
2016 BIO International Convention
I enjoyed 2016 BIO International Convention held at Moscone Center, San Francisco, CA on June 6-9, 2016. http://convention.bio.org/2016/ California booth; Business Partnering booth; Did you grab BIOCOM LifeLines and take a look on page 21? Then you can find us!! https://www.biocom.org/s/LifeLines
User Requirements Specification – URS
The User Requirements Specification (URS) is the first in a series of documents in the process of bringing a stability chamber online. The URS is the documentation at a high level that lists the user’s physical requirements for the chamber. This documentation includes the chamber’s intended operation; the general...
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 #5
Related FDA483/Warning Letter The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically: Sub section (b)There is no written standard operating procedure in place to (A) control, secure, and allow authorized personnel to access the stability chambers. It appears that...
FDA 483 Tips #4
Procedures describing the calibration of instruments and apparatus are deficiently written or followed. Related FDA483/Warning Letter b) The two calibration points evaluated were 0 C and 100 C, thus there was no challenge to the actual range of operation which were mentioned to be C to C....
FDA 483 Tips #3
Procedures describing the calibration of instruments and apparatus are deficiently written or followed. Related FDA483/Warning Letter d) The (A) calibration program for your stability chambers is deficient in that it does not include specific directions and schedules. You do not (B) perform re-qualification of the stability chambers. The original...
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...