International Conference validation guidelines

The method was validated in accordance to the guidelines of the international conference on harmonization (ICH). Data with respect to accuracy, within- and between run precision, recovery, detection and quantitation limits were reported and found to be within the accepted international criteria. Neither endogeneous substances nor the commonly used dmgs were found to interfere with the retention times of the analytes. Standard solutions of the dmg and quality control preparations at high and low level concentrations were demonstrated to be stable at room temperature and/or -20°C for long and short periods of time. 

International Conference on Harmonization, Guideline on validation of analytical procedures definition and terminology, Fed. Reg., 60(40), 11260 (1995). 

International Conference on Harmonisation, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures Methodology, November 1996. 

Guidelines prepared within the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), Validation of Analytical Procedures, Q2A Definitions and Terminology, 1995, pp. 1-5, http //www.ich.org/... 

Quantitative CE—MS studies were scarcely reported. " This subject is however of prime importance, particularly for the pharmaceutical industry where the reliability of analytical data is essential. For this reason, method development is generally followed by an evaluation of quantitative performance using an appropriate validation procedure performed in agreement with criteria established by the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) and the Food and Drug Administraction (FDA) guidelines, or Societe Franqaise des Sciences et Techniques Pharmaceutiques (SFSTP) commissions. ... 

International Conference on Harmonization (ICH) (2005, Nov.), Harmonised tripartite guideline Q2(R1), Validation of analytical procedures Text and methodology. 

FIP (1980) Federation International Pharma-ceutique, Commission of Official Control Laboratories and Industrial Pharmacists, Conference 1980 Guidelines for Good Validation Practices [4] Definition, development phase, production phase, validation of existing processes, revalidation, responsibilities... 

Moffat, A.C., Trafford, A.D., Jee, R.D. and Graham, P. (2000) Meeting of the international conference on harmonisation s guidelines on validation of analytical procedures Quantification as exemplified by a near-infrared reflectance assay of paracetamol in intact tablets Analyst 125, 1341-1351. 

International Conference on Harmonisation, Guideline on Validation of Analytical Procedures, Q2A, Code of Federal Register, Vol 60, no. 40, p. 11260, March (1995). 

Department of Health and Human Services, Food and Drug Administration. International Conference on Harmonisation Guideline on Validation of Analytical Procedures Methodology Availability, docket no. 96D-0030. May 19,1997. 

International Conference on Harmonization (1997). Guideline on Validation of Analytical Procedures Methodology. Federal Register 62, 27463-27467. 

International Conference on Harmonization Guideline on Data Elements for Transmission of Individual Case Safety Reports. This document s efforts focus on quality control/quality assurance endeavors to ensure accuracy and to promote validation in the handling of case safety reports for both preapproval and postapproval periods. It covers both adverse drug reaction and adverse event reports. 

International Conference on Harmonisation Draft Guideline on Validation of Analytical Procedures for Pharmaceuticals Availability, Fed. Reg., 59 9750 (1994). 

Adding to this problem is the lack of unambiguous, scientifically valid guidelines from the International Conference on Harmonization (ICH) guidance (1). This leads to having to choose between what the user thinks the regulators want and the scientific approach. 

In 1996 and 1997 the International Conference on Harmonization (ICH) published guidelines for analytical method validation [8]. These documents present a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan, and the United States. 

A. C. Moffat, A. D. Trafford, R. D. Jee, P. Graham, Meeting the International Conference on Harmonisation s Guidelines on Validation of Analytical Procedures Quantification as Exemplified by a Near-Infrared Reflectance Assay of Paracetamol in Intact Tablets, The Analyst, 125(7), 1341-1351 (2000). 

As required by regulatory authorities [1-3, 6] and International Conference on Harmonisation (ICH) guidelines [7], analytical method validation is especially important in establishing the assay methods and procedures of quantitative or semi-quantitative measurement of target substances or compounds. Among the specification items for drug products, assay, content uniformity, and dissolution are typical of those which require almost full analytical validation. The purity test, related... 

The FDA, USP, and International Conference on Harmonisation provide guidelines as to which combinations of these validation characteristics are appropriate for each procedure being validated. At Novartis, Table 1 is used to determine the degree of validation required for a given analytical procedure. Using Figure 10, the test is placed into one of five groups, which are identified in Table 1. 

Although the requirements of validation have been clearly documented by regulatory authorities, the approach to validation is varied and open to interpretation. The following approach will focus on the International Conference on Harmonization (ICH) guidelines. Also, because validation requirements differ during the development process of pharmaceuticals, this chapter will emphasize requirements for later stages of development and for methods used to evaluate marketed products. 

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