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August 01, 2015

Four Essential SOP's.

Now is the time to ensure that there are no breaches in your GMP compliance compliance. The lack of one or more of these four SOP's is responsible for over 50% of regulatory citations. Shown briefly in video format they are being offered as a package at the indicated price, which shows a substantial saving on the individual purchase price.

Do not miss this offer it may not be made again.

New Document 10000130 SOP Calibration of Sensors (Issue-3).

21 CFR Part 820 and 210 mandates that where the accuracy of instruments and or instrument sensors is judged as critical to the final efficacy, quality and or safety of a regulated product or could prove injurious to the integrity of any associated predicated data or data records; the individual instrument must be considered as a, “Critical Instrument”. Critical instruments must be entered into a planned calibration program and subjected to routine calibration against master instruments traceable to national standards, at a periodicity that has a written justification. They must be placarded with a “Calibrated Label”. This SOP lists, details and defines each of the 11 essential elements of cGMP compliant calibration and calibration management. It includes sample document formats, calibration labels layouts and details the importance of the post calibration report. The SOP concludes with a fully detailed; ready to use, Calibration Manager Auditor document. This is your complete calibration SOP to purchase and use.


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