Quality levels of pharmaceutical items are set out in various test procedures and instruments. US pharmacopeia, which deals with specifications of drugs and other pharmaceutical products, uses the following criteria to assess the method validation of these products:
- detection limit
- quantitation limit
Types of test methods
USP 1225 establishes the types of test methods. These are:
- testing for impurities – quantitative
- testing for impurities – limit
Specificities of USP 1225
Failure to meet regulatory expectationsunder USP 1225 typically invites statements such as “Failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm”, which will be the explanation the FDA gives for failure of compliance, leading to the issuance of a 483. Such an observation reflects the lack of understanding of the nuances of method validation on the part of the analyst.
The way out
Test methods that meet USP standards are essentially about common sense. The analyst has to understand and identify the foundational aspect of test validation –the intended use of the test method. This is what enables her to categorize the test method into one of the types prescribed by the USP. This will be the gateway to a clearer understanding of the guidance set out in USP 1225. This is because the underlying matter is that the analyst must prove that the method performs exactly as intended. This is what forms the basis of the above criteria and test methods.
1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801