Current Requirements for Cleaning Validation

Validation of cleaning procedures is critical for any cleaning programme as defined in the current GMP Guidelines (Annex 15, Section 10): "Cleaning Validation should be performed in order to confirm the effectiveness of a cleaning procedure for all product contact equipment"

Since the first statement regarding cleaning in the GMP Regulations, the number of guidelines has greatly increased, especially since 2000. This has coincided with the increased focus by regulators within this area.

This course covers topics such as the development of regulatory expectations, effective cleaning procedures, process validation and control of these procedures. It will cover all areas from the inception of a cleaning strategy and policy through the development and performing of the exercise to the maintenance of the validated cleaning regimes.

For those new to this area, this course provides a detailed and structured introduction to cleaning validation, whilst for those who have been working in the field for some time this up to the minute course will provide details of current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets. 50% of the course will be spent in lectures and the remainder will be spent performing practical exercises and in interactive workshops. It will cover subjects such as development of regulatory expectations, effective cleaning procedures and disinfectant regimes, development of effective cleaning techniques, interactive case studies and the validation and control of these procedures.