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 pharmaceutical validation course from the Honeyman Group 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 the 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.

Who Should Attend This Course?

This validation course will be beneficial to newcomers and experienced personnel from QC, Validation, Engineering, Production, and QA.

Course Objectives

Upon completing the course delegates will:

• Understand the key GMP requirements for cleaning validation and verification
• Understand the methods of cleaning including manual, automated or COP
• Be able to develop effective cleaning procedures
• Understand the significance of product development data in cleaning validation
• Develop approaches based on scientific rationale
• Develop protocols, define worst-case locations, set limits and define acceptance criteria
• Apply best practice techniques for direct surface sampling and recovery
• Understand the suitability and technology associated with specific and non-specific analytical techniques
• Apply risk assessment techniques
• Understand the importance of maintaining the validation state: cleaning stability studies and change control