In September 2013, the United States Pharmacopeial Convention (USP) published a stimulus to the revision process to adopt quality-by-design principles for the development, validation, and operation of analytical procedures used for good manufacturing practice (GMP) analysis. In February 2014, this was followed by a draft Food and Drug Administration (FDA) guidance for industry on validation of analytical procedures. Also, the FDA issued a new draft that updates their 2001 guidance for industry on bioanalytical method validation. Are the approaches the same? What do you think?
I live in London and we have a saying here: You wait a long time for a bus and then three turn up at once. Recently, in method validation a similar thing has occurred and three draft documents for method validation have been issued over a relatively short time span. Two of these method validation documents are intended for laboratories following good manufacturing practice (GMP) principles and one is for bioanalytical laboratories following good laboratory practice (GLP) principles.
The three documents are
Analytical method development, procedure validation, and transfer to other laboratories to carry out routine analysis are key parts of the traditional analytical process. This starts, if you're lucky, with defining what you want the method to do and ends up with the operational use of the procedure. In the middle is the stuff that should be done properly, but usually is not, as evidenced by how poorly a method operates in routine use. This oversight typically occurs because the method development and validation is performed by one group and the operation of the procedure is carried out by another group. In many instances, the two groups rarely talked to each other except when things went wrong — and blamed each other for the problems. Of course, this never happens in your organization, does it?
In the Beginning . . .
Method validation is not new because there have been a number approaches over the years in both GMP and GLP quality disciplines. Validation of GMP analytical procedures was harmonized with the agreement of the International Conference on Harmonisation (ICH) quality publications Q2A and Q2B covering the text and methodology of validation of analytical procedures respectively (4,5) in 1994 and 1996, respectively. These two publications were merged into a single document with the revision as ICH Q2(R1) in 2005 without changing any text (6). The first bioanalytical methods validation conference was held in 1990 (I was a co-chair of one of the sessions), sponsored by the FDA and the American Association of Pharmaceutical Scientists (AAPS), that drew up the first guidelines for bioequivalence and bioavailability studies typically carried out under GLP (7). This led to the FDA issuing a guidance for industry on bioanalytical methods validation in 2001 (8).