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 Q7 “GMP for APIs” also requires cleaning validation – as well as two guidelines by APIC, the association
of European API manufacturers. A new Guideline from EMA on Dedicated Facilities and Exposure Limits for Cleaning Validation and the revised Annex 15 now deal with a PDE (Permitted Daily Exposure) approach. Background Many questions relative to cleaning validation are still open and have to be answered within the companies:
Background
Many questions relative to cleaning validation are still open and have to be answered within the companies:
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?
How helpful can a riboflavin test be?
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 are critical areas defined?
Is cleaning evaluation the solution for seldom manufactured products?
Which microbiological maximum values are valid in the areas of non-sterile dosage forms and APIs?
and
Special aspects of cleaning validation in biotech API plants These questions will also be discussed with the help of practical examples.
Target Group
This course is directed at staff of R&D, production and quality assurance involved in cleaning validation. It also addresses Engineering companies interested in learning more about the pharmaceutical industry‘s viewpoint and in exchanging experiences. Note: The number of participants is limited.
Four parallel Workshops
Four parallel workshops, concentrating on medicinal products, chemical and biological manufactured APIs, and about the organisation of cleaning validation guarantee the practical orientation. Please choose your workshop when registering.
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Seminar Programme as PDF