Chemistry Reference
In-Depth Information
applied to instruments in this group. Installation of instruments in this group can
be quite complicated and is often only undertaken by specialists. Examples include
HPLC and gas chromatography (GC) instruments, mass spectrometers, and electron
microscopes.
One word of caution regarding the instrument groupings: the exact category that an
instrument falls into can only be determined by the user and its intended application.
2.8 conclusIon
Data quality is built on the foundation of method and software validation, AIQ, and
system suitability. Each of these components plays a critical role in the process of
validation. In a regulated laboratory, instruments must generate reliable data, and
only a proper AIQ process can fulfill this mission. An approach as outlined in the
USP and AAPS committee report that focuses on scientific principles rather than
simply generating paperwork will increase laboratory efficiency and make the vali-
dation process less subjective and easier to defend.
reFerences
1. Swartz, M.E. and Krull I.S.,
Analytical Method Development and Validation
, Marcel
Dekker, New York, 1997.
2. Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or
Holding of Drugs, 21 CFR Part 210, http://www.fda.gov/cder/dmpq/cgmpregs.htm.
3. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR Part
211, http://www.fda.gov/cder/dmpq/cgmpregs.htm.
4. United States Food and Drug Administration, Guideline for Submitting Samples and
Analytical Data for Methods Validation, February 1987. US Government Printing
Office: 1990-281-794:20818, or at www.fda.gov/cder/analyticalmeth.htm.
5. Draft Guidance for Industry: Analytical Procedures and Methods Validation. U.S.
Department of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, Center for Biologics Division of Research, Rockville,
MD, August 2000.
6. ICH Q2 (R1): Validation of analytical procedures: Text and methodology,
International
Conference on Harmonization of Technical Requirements for the Registration of Drugs
for Human Use,
Geneva, Switzerland, November 2005. See also www.ich.org.
7.
The United States Pharmacopeia 34/National Formulary 29
, The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <1225>.
8.
The United States Pharmacopeia 34/National Formulary 29
, The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <621>.
9. Hertzog, D.L. et al., Developed and validated stability-indicating HPLC method for the
simultaneous determination of losartan potassium, hydrochlorthiazide, and their deg-
radation products,
Pharm. Forum
, 31(5), L10587, Analytics Instrument Qualification
Sept-Oct 2005, pp. 1453-1463.
10.
The United States Pharmacopeia 34/National Formulary 29
, The United States
Pharmacopeial Convention, Inc., Rockville, MD, 2011, Chapter <1058>.
11. Qualification of analytical instruments for use in the pharmaceutical industry: A scientific
approach,
AAPS PharmSciTech
, 2004, 5(1) Article 22 (http://www.aapspharmscitech.org).
