◆ EU GMP Non-Compliance Report might lead to FDA Import Stop in future (11-Apr-17 ECA) The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn’t conclude though that the inspection pressure would decrease now because...
Posts Tagged with FDA 483
Stability Testing related News – Vol.4
◆ GDUFA: FDA’s new Guidance on Self-Identification of Generic Drug Manufacturers (05-Oct-16 ECA) The GDUFA (Generic Drug User Fee Amendments) is a legislative package which came into force in 2012 and entitles the US-American FDA to collect fees from generic drug manufacturers, who strive for a marketing authorisation for...
Equipment Outages Documentation
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...
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...
Stability Chamber Qualification in US
You can find the information of stability chamber qualification from the viewpoint of regulations (guidances), operations and issued 483s. 41+ Years Subject Matter Expert (SME) of the stability chamber management in the US Fortune 100 and 500 Pharma Company, Mr. Gary Ostermiller has shared his experience as below. Through...
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...