Page 46 - Quality control of pharmaceuticals (07-PA 704)

VALIDATION PARAMETERS
1) ACCURACY:
• The accuracy of an analytical procedure expresses the closeness or agreement

between the experimental value and the true value.
• This is sometimes termed trueness
• Accuracy should established across the specified range of the analytical

procedure
• Accuracy is established for a procedure used for:

a) Assay of drug substance
b) Assay of drug product
c) Quantitation of impurities or degradation products

Assay
a) Drug substance:

Several methods are available:
• Application of the analytical procedure to an analyte of known purity (e.g.

reference material)
• Comparison of the results of the proposed analytical procedure with those of

a second well-characterized procedure, the accuracy of which is stated and /
or defined (independent procedure)

b) Drug product:

Several methods are available:
• Application of the analytical procedure to synthetic mixtures of the drug

product components (Placepos) to which known quantities of the drug
substances to be analyzed have been added.