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Articles from May 2016

FDA 483 Tips #5

FDA 483 Tips #5

May 29, 2016

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...

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FDA 483 Tips #4

FDA 483 Tips #4

May 24, 2016

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....

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FDA 483 Tips #3

FDA 483 Tips #3

May 22, 2016

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...

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FDA 483 Tips #2

FDA 483 Tips #2

May 17, 2016

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),...

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FDA 483 Tips #1

FDA 483 Tips #1

May 15, 2016

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...

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