Analytical Methods for Cleaning Validation - Live Online Training

This live online training 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  nonspecific residues (such as detergents, drug excipients and active ingredients)  which may not be determined by HPLC, will be highlighted. Prior to this, the concept of 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 analytical procedure is an efficient  sampling recovery and therefore, the first part of the course will highlight the various techniques of sampling recovery.

 

The second part of the live online training will address a systematic validation of the analytical method for cleaning residues. Performance characteristics of the analytical method  (accuracy, precision, linearity, robustness, sensitivity and sampling recovery) will be systematically presented.

 

This Live Online Training combines presentations and practices with Excel, which allows all delegates to apply the presented theory directly into practice. Therefore, a device with installed Excel programme is required.

Initiating a manufacturing of pharmaceutical in shared equipment requires demonstrating that no cross-contamination from previous product takes place.  Optimally, residues from previous manufactured product or API or residues from the cleaning agent itself should be absent or very low. The validation of any cleaning process relies heavily on the validity of the test results provided by the analytical procedure for cleaning residues.  However, here lies the challenge facing an analytical chemist: the need to develop and validate an analytical method that is sensitive enough to detect and reliably quantify well recovered trace amounts of chemicals and practical enough to rapidly deliver results.

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