Best Practices for an Effective Cleaning Validation Program
COURSE AGENDA
DAY ONE
FDA Requirements and Industry Standard Practices
Regulatory requirements
Industry references
How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
CIP, COP, Manual Cleaning procedures – advantages and disadvantages
Selection of Cleaning Agents for your equipment/product and adequate Parameters to provide best results
How to Develop a Cleaning Validation Policy/Program
Why do you need a policy/program?
Key elements of a policy/program
How to Develop a Cleaning Validation Plan
Information required
Review of cleaning processes/procedures
Analytical Method development and validation
How to select challenge conditions and determine acceptance criteria – application of a matrix approach, worst case selection, determination of the sampling plan and limit calculations
Documentation requirements – protocols and reports
Microbiological Aspects of a Cleaning Validation Program for Manufacturing Equipment:
Cleaning after use versus sanitization before use
Typical sanitization procedures
Testing requirements
DAY TWO
Keys to Cleaning Validation Maintenance – Remain Under a Validated Status
Change Control:
Cleaning/Sanitization Agents, Cleaning Procedures, Manufacturing Equipment or Procedures and changes in Product Formulas
Proper evaluation and approval pre and post change implementation
Documented evaluation and follow up
Monitoring after equipment cleaning – Visual Inspection and Frequent Sampling/Testing
Monitoring after area cleaning/sanitization procedure
Practice on Specific Pharmaceutical/Biopharmaceutical Cleaning Validation Protocols
Discuss typical cleaning processes to be validated
Practice, practice, practice – developing cleaning validation protocols for pharmaceutical and biopharmaceutical processes including the determination of the residue limits to be used as acceptance criteria
Current FDA Concerns about Validation of Cleaning Processes
Cleaning validation deficiencies observed by the regulatory inspectors, as reported in Establishment Inspection Reports (EIRs), FDA 483 observations and Warning Letters!!!
The Future of Cleaning Processes and Cleaning Validation
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