MTS HELPDESK:
In ICH Q2(R2), the guideline about validation of analytical procedures that is used in the pharmaceutical/biopharma industry, it states that: ‘The objective of validation of an analytical procedure is to demonstrate that the analytical procedure is suitable for the intended purpose.’ Therefore, the aim of a validation study is to generate evidence which provides the proof that the method works as intended.
Category: MTS Helpdesk
ICH Q2(R2) Validation Gap Assessment
MTS HELPDESK:
What are the differences between the ICH guideline, Q2(R1) and the updated version, Q2(R2), that would be identified in a gap assessment of an analytical procedure validation study which was originally performed following version Q2(R1)?
What is an Analytical Procedure Lifecycle?
MTS HELPDESK:
What are the elements of the Analytical Procedure Lifecycle, as mentioned in guidance documents such as ICH Q14 and USP <1220>?
Limit of Quantitation: Does it Matter?
MTS HELPDESK:
Is the limit of quantitation always important when validating methods for impurities?
How Long to Equlibrate an HPLC Column?
MTS HELPDESK:
How long does it take to equilibrate a column on an HPLC system before the first injection can be performed?
HPLC Mobile Phase Expiry Dates
MTS HELPDESK:
What is the typical (the industrial ‘norm’) for the expiration date of mobile phases for HPLC, i.e. with buffer and without buffer. Also, what should you do (e.g., measure the pH or run and verify the retention time) if you need to extend the expiration date in extenuating circumstance e.g. shortage of acetonitrile or delay of the orders from the vendor, etc.?