Page 45 - Quality control of pharmaceuticals (07-PA 704)

Typical validation characteristic which should considered are listed below:
• Accuracy
• Precision (reproducibility, repeatability, intermediate precision)
• Specificity
• Detection limit
• Quantitation limit
• Linearity
• Range
• Robustness

Revalidation of the analytical procedure may be necessary in the following
circumstances:

• Changes in the synthesis of the drug substances
• Changes in the composition of the finished product
• Changes in the analytical procedure