Cleaning Validation 7-8 April 2011 Vienna, Austria Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1690,--) Book this option: ECA Members (EUR 1490,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (does not include ECA membership) (EUR 1590,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Background In the manufacture of medicinal products and APIs, the cleaning of facilities and equipment is an important measure to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. In the past, cleaning effectiveness was often monitored only visually. However, residuals of APIs and excipients as well as of detergents are increasingly an issue in inspections and audits. The success of cleaning procedures has to be validated. In addition to the FDA “Guide to Inspection of Cleaning Validation”, the PIC/S document PI 006 and Annex 15 address cleaning validation in a separate chapter. Moreover, the ICH Guideline Q7A “GMP for APIs” also requires cleaning validation – as well as two guidelines by APIC, the association of European API manufacturers. Learning Goals Many questions relative to cleaning validation are still open and have to be answered within the companies: How does a cleaning procedure have to be designed for validation, and who is in charge? What does the cleaning validation concept have to look like to be GMP-compliant and cost-effective? Which risk analyses are applicable to cleaning validation? Which maximum value is scientifically acceptable, especially in the field of APIs? Which sampling procedure is appropriate for which process and facility? How can you cut costs by means of Bracketing? How do you integrate the analytical laboratory into cleaning validation? How are critical areas defined? Is cleaning evaluation the solution for seldom manufactured products? How can the cleaning of an old or upgraded site be validated? Which microbiological maximum values are valid in the areas of non-sterile dosage forms and APIs? Which deficiencies can be found in mock inspections? and How do facilities need to be designed to be cleanable in the first place? These questions will also be discussed with the help of practical examples.