What is cleaning validation and where does it fall in the global Life Cycle Validation scheme? How can an automated washing system be validated? This presentation provides insights that may help to respond to these questions.
The Life Cycle Approach is a good way to standardize a company’s manufacturing and cleaning processes. The 2011 FDA Guidance document entitled: ‘’Process Validation: General Principles and Practices’’ describes process validation activities into 3 stages; Process Design, Process Qualification and Continued Process Verification
Stage 1 for an automated washing system comprises the User Requirement Specifications aspect, in other words, what exactly should be considered when acquiring an automated washing system and what outside parameters have an impact on its proper use.
Stage 2 covers the validation strategy, load configuration, cycle operation, acceptance criteria, analytical and sampling methods, amongst other things that will be further explained.
Finally, Stage 3 discusses preventative maintenance activities and how continuously monitoring of the cleaning process can help maintain a state of control when producing drugs at a commercial scale.
When: June 6, 2017 at 10:00 AM - 11:00 AM EST