Page 33 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

sensitivity (limit of quantitation or limit of detection of the method)

linearity and range (over what range the method measures the analyte in
direct proportion)

ruggedness (how the test method is affected by reasonable changes)

GMP regulations require that all critical steps of manufacture are reliable or
validated. If a method is not validated, it is difficult to be assured results are

reliable.

GOOD TO KNOW – PROCESS VALIDATION

Over the last years, the industry has learned by experience that:

"Quality cannot be tested into product, but must be built in at each stage of

manufacture.”

This statement is the basis of process validation. Process validation assures
that under specific and documented operating conditions, a process step will
perform reliably, be in control, and will deliver a quality product every time.
Limited laboratory testing is conducted to confirm that the process is still
operating satisfactorily. To conduct process validation, the following must be

defined:

(a) Process inputs: The critical process parameters, or CPPs, that may affect
process reliability. Often, CPPs could be time, temperature, speed, order of
addition,
etc.

(b)Process outputs: The product critical quality attributes, or CQAs, that the
process delivers. Examples of CQAs include strength or potency, particle size,
moisture, purity, weight, appearance, and dissolution. CQAs will vary with the

type of product manufactured.

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