Regulatory requirements performance characterization

Performance and Regulatory Requirements describes various ways of characterizing the dry powder aerosols and provides information on product quality performance requirements and how these attributes must be reflected in registration applications. 

A major factor affecting the quality of the final result is the suitability of the analytical method applied. Ensuring that the method is fit for purpose can be considered a basic quality control criterion. It is important that laboratories restrict their choice of methods to those that have been characterized as suitable for the matrix and analyte of interest, and at the level of interest. In the EU, and in many other countries and regions, the regulatory limit for authorized veterinary medicinal products is the maximum residue limit (MRL), and for contaminants the maximum permitted limit. Eor prohibited or unauthorized analytes, there is often a threshold or action limit set in Europe, for example, the appropriate regulatory limit is the minimum required performance limit (MRPL) or the reference point for action (RPA), as defined in Article 4 of Commission Decision 2002/657/EC, Article 2 of Commission Decision 2005/34/EC, and Articles 18 and 19 of Council Regulation (EEC) 470/2009.2 ... 

Standardization The instrument response function can vary from analyzer to analyzer. If calibration transfer is to be achieved across all instrument platforms it is important that the instrument function is characterized, and preferably standardized [31]. Also, at times it is necessary to perform a local calibration while the analyzer is still on-line. In order to handle this, it is beneficial to consider an on-board calibration/standardization, integrated into the sample conditioning system. Most commercial NIR analyzers require some form of standardization and calibration transfer. Similarly, modem FTIR systems include some form of instrument standardization, usually based on an internal calibrant. This attribute is becoming an important feature for regulatory controlled analyses, where a proper audit trail has to be established, including instrument calibration. 

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