With the entry into force of the revision of Annex 15 EU GMP Guideline in 2015, the requirements for limit value determination for cleaning validation became more stringent. A substance-specific, scientific justification for the limit value calculation for active ingredients and cleaning agent residues is required.
However, not only the limit value determination and the PDE concept are discussed in this online event by the FORUM Institute. In addition to conveying essential basics (regulatory requirements, cleaning procedures, acceptance criteria, errors & findings), the focus is also on the practice-oriented implementation of the validation master plan according to the risk-based approach. Concept development, documentation, minimization of effort and costs (bracketing, matrixing) are just a few of the keywords to be mentioned here.
Raimund Brett, Principal Consultant at gempex GmbH, will present the above topics as an invited GMP expert. In addition, he presents the ideal-typical cleaning validation report as well as how to deal with deviations and OOS. In the subsequent workshop, all participants will focus on the different aspects of creating a validation master plan.
Further topics of the online seminar are the different methods of sampling (swab, rinse, solvent rinse, microbiology, etc.) as well as special aspects in the validation of analytical methods for purification (detection and quantification limits, recovery rate, specificity and sample preparation, etc.). The seminar is aimed at employees in production and quality assurance who are involved in cleaning validation.
Raimund Brett will be happy to answer any further questions on this topic: info@gempex.com.
Information and registration options for the online seminar "Cleaning validation in pharmaceutical manufacturing" on the organizer´s website Forum-Institut.