Pharmaceutical Technology-10-02-2014

Pharmaceutical Technology

Determining Facility Mold Infection

October 02, 2014

Troubleshooting

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The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

Using the Guard Band to Determine a Risk-Based Specification

October 02, 2014

Peer Reviewed

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10

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.

Pharmaceutical Technology, October 2014 Issue (PDF)

October 02, 2014

38

10

Click the title above to open the Pharmaceutical Technology October 2014 issue in an interactive PDF format.