Objectives

This course consists of two parts. 
The first part revolves around the development of suitable analytical methods. The characteristics of these methods (HPLC, HPTLC, TOC, conductometry, pH, total protein, visual inspection etc…) will be discussed in the light of their capability of detection and quantitation of residues. In particular, the advantages of the TOC method in accurately detecting and quantifying low levels of non-specic residues (such as detergents, drug excipients and active ingredients) which may not be determined by HPLC, will be highlighted. Prior to this, setting Maximal Carry Over (MAC) limits according to PIC/S, FDA and WHO guides will be presented along with the new EMA approach based on toxicity thresholds. Finally, a pre-requisite requirement for a well-developed method is an efficient recovery and therefore, the first part of the course will highlight the various techniques of sample recovery.

The second part of the course will address a systematic validation of the analytical method for cleaning residues. Performance characteristics of the analytical method will be systematically presented, discussed in parallel to guided calculations of examples with Excel.

Programme

• Introduction
• Cleaning Method Characteristics
• Sampling Techniques of Cleaning Residues
• Calculation of Allowable Carryover (MAC)
• Workshop
• Specifity of measurement method
• Accuracy (incl. exercises with Excel)
• Precision of measurement method (incl. exercises with Excel)
• Detection and Quantitation Limits of measurement methods (incl. exercises with Excel)
• Linearity of measurement method (incl. exercises with Excel)
• Range
• Robustness
• Documentation of method validation