Fundamental and Cleaning Validation Best Practices

Engineering and Validation

Laboratory

Operations

Quality

Target Level

This course is relevant to all individuals involved in pharmaceutical Operation including but limited to:

• Professionals responsible for all aspects of cleaning validation programs, including development, deployment, and maintenance
• Quality assurance specialists, quality control technicians, regulatory affairs professionals, pharmacologists and toxicologists, validation scientists, and validation service personnel
• Manufacturing supervisors, technical support personnel, and engineers responsible for evaluating cleaning systems, reviewing equipment, and supporting the cleaning validation program on the plant floor
• All levels of management who need to understand the science of cleaning and cleaning validation including the aspects of residue selection, sampling method and analytical detection method validation, limits determination, and strategies for managing multi-product facilities
• Process Scale-Up, Optimization, and Technology Transfer Engineers
• Internal / External Auditors and Consultants
• Regulatory Authorities

Description

• Current regulatory guidelines in cleaning validation (FDA, EMA, and PICs)

-  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. - Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’

• Life cycle approach to cleaning validation
• Cleaning processes
• Cleaning validation vs Cleaning verification
• Risk-based approach -Grouping strategies
• Historically cleaning validation limit and new health-based limits

- A scientific approach to establishing residue limits and acceptance criteria.

• Acceptance criteria calculation
• Sampling locations and methods
• Analytical method validation
• Hold time studies: DHT, CHT
• Cleaning validation documentation
• Cleaning validation maintenance
• Case studies

Objectives and Expected Results

• Participants will develop scientific-based knowledge to understand the principles of science- and risk-based approach to the Cleaning validation lifecycle.
• Able to develop a practical methodology to monitor the cleaning process performance
• Develop tools to prepare for a smooth cleaning validation execution.
• Identify and understand the consequences of cleaning validation deviations.
• Appreciate the need to validate or verify your plant cleaning
• Fully understand the documentation and legal requirements for Cleaning Validation
• Recognize good and bad practices for cleaning validation
• Be able to calculate acceptance criteria for the cleaning process
• Be able to clearly identify what constitutes ‘visually clean’
• Be aware of the issues surrounding sampling and testing techniques
• Residue determination, analytical methods, and limit calculations
• Common issues and how to deal with failures during the cleaning program.

Others Training Materials

Workshop materials will be provided

Target group