Seminar Nr. 17075
Tel.: 06221 / 84 44 0 E-Mail: firstname.lastname@example.org
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.
Initiating the manufacturing of a pharmaceutical in shared equipment requires demonstrating that no cross-contamination from previous product takes place.
Optimally, residues from a previously manufactured product or API or residues from the cleaning agent itself should be absent or very low. 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.
The addressees of the event are analytical chemists testing the residues, quality control personnel, quality assurance personnel, regulatory affairs professionals and validation personnel also involved in cleaning validation.
The participants should bring a laptop with Excel.