Chemistry Reference
In-Depth Information
tAble 1.1
IcH guidelines pertaining to Amv
guideline
subject
title
Q2(R1)
Analytical Validation
Validation of Analytical Procedures: Text and Methodology
Q1A(R2)
Stability
Stability Testing of New Drug Substances and Products
Q1B
Stability
Stability Testing: Photostability Testing of New Drug
Substances and Products
Q1C
Stability
Stability Testing for New Dosage Forms
Q3A(R2)
Impurities
Impurities in New Drug Substances
Q3B(R2)
Impurities
Impurities in New Drug Products
Q6A
Specifications
Specifications: Test Procedures and Acceptance Criteria for
New Drug Substances and New Drug Products: Chemical
Substances (including Decision Trees)
Q6B
Specifications
Specifications: Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products
Definitions and Terminology was finalized (Step 4) in October 1994. This guide-
line identified the validation parameters required for analytical methods. It also dis-
cussed the characteristics that must be considered during the validation of analytical
procedures that are included as part of the registration process. Q2A: Definitions and
Terminology was published in the
Federal Register
in 1995 and is now considered
implemented [7]. The harmonized ICH text of Topic Q2B: Methodology was final-
ized (Step 4) in November 1996. Q2B extended Q2A to include the actual experimen-
tal data required, along with statistical interpretation for the validation of analytical
procedures. Q2B: Methodology was also published in the
Federal Register
in 1997,
and is also considered implemented [8]. In November of 2005, Q2A and Q2B were
combined into a single guideline, Q2 (R1), and renamed “Validation of Analytical
Procedures: Text and Methodology” [9]. While guideline Q2 (R1) certainly forms
the foundation for method or procedure validation, several additional guidelines are
also pertinent to any method validation discussion, and these are summarized in
Table 1.1. All the ICH guidelines significantly affect people working in the valida-
tion area, and should be consulted, as these guidelines have been incorporated into
the USP, and federal regulators often reference these documents.
It should be pointed out that the ICH is not a regulatory body, or in the busi-
ness of generating duplicate guidelines. Rather, the ICH has provided clear (with
respect to global compendia) guidance on several topics, with, among others, the
FDA as willing participants. This participation has helped to ensure that a single
set of current guidelines is adopted and maintained through the normal regulatory
process.
1.5 Amv guIdAnce
Guidelines are documents prepared for both regulatory agency personnel and the pub-
lic that establish policies intended to achieve consistency in the agency's regulatory
