Pharmaceutical Analytical Method Validation and Cleaning Validation

Course Description:

Cleaning is of vital importance to the product safety in the pharmaceutical manufacturing. This training program will cover the key GMP requirements for cleaning validation, the methods of cleaning, effective cleaning procedures, developing effective cleaning procedures, approaches to cleaning validation based on scientific rationale, different analytical techniques, and risk assessment in the cleaning validation. This course provides a detailed and structured introduction to cleaning validation, as well as details of current best practice, cGMP expectations, industry trends and regulatory issues for both the EU and US markets. Therefore, it is suitable for both new and experienced professionals in this field. This course will help the attendees with a better understanding of regulatory requirements and technique.

Analytical methods used to test products should have quality attributes built into them, and analytical method validation is used to both demonstrate that the method is fitted for its purpose and to meet the regulatory requirements. This training course gives a review and strategy for the validation of analytical methods. It will provide both theoretical understanding and practical knowledge of the method validation progress. The regulatory requirements on method validation and their implications in the pharmaceutical industry will also be discussed. This presentation can guide managers and analysts through all aspects of analytical methods validation. The difficulties encountered in carrying out method validation will be covered. This course also addresses the setting up of acceptance criteria and the application of method validation in herbal medicines. Strategies and recommendations for the validation of internally developed methods and verification of compendial methods will also be given.

Learning Objective:

• State the GMP reasons for cleaning validation
• Interpret regulatory requirements and guidelines
• Outline a strategy for cleaning validation that complies with cGMPs
• Apply risk management principles to identify cleaning validation parameters
• Cleaning process variability & controls
• Develop practical limits for cleaning residues
• Risk based approach to grouping strategy
• Develop a basic cleaning validation protocol
• State the requirements for laboratories in support of cleaning validation studies
• Parameters required for analytical method validation
• Discussion of acceptance criteria for method validation parameters
• Regulatory requirements for analytical method validation
• Requirements for inter-laboratory method transfer
• Requirements for verification of compendial and other official methods
• Setting up acceptance criteria
• Method validation: a life cycle process
• Method validation for herbal medicines
• Allowed method adjustments
• Practical problems encountered in the method validation