Topic: The difference between a monitor and an analyzer17 February 2006 Last edited: 9 September 2013 At 6:31pm
pharmamanufacturing Manufacturing Community Member 56 Posts
Re: The difference between a monitor and an analyzer17 February 2006 at 12:00am Last edited: 9 September 2013 at 6:31pm
Emil Ciurczak responds:
Normally a "monitor" is continuously measuring (or monitoring) some physical/chemical parameter. The output is relative to a previous run or standard level of voltage, resistance, absorbance, etc. In other words, we might have an upper control limit or lower control limit without units. Another way is chemometrically using Mahalanobis distances, Principal Components, or Conformity Index to ascertain that the current material is similar to or "dissimilar from" previous acceptable batches.
An analyzer uses a quantitative algorithm and the output is closer to "99.6% of label." It will be a "formal" analytical result and need as much validation as a QC method.
In most cases, a monitor will not trigger the need for 21 CFR Part 11 to be employed. An analytical output will.