Presented by Joe McGuinness, EAS Independent Consultant.
July 13, 2021 at 1pm eastern.
For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s current Good Manufacturing Practices (cGMPs), the protection against cross contamination must be detailed in SOPs, with outlines for cleaning processes used for various pieces of equipment for every scenario, including a procedure to validate the cleaning procedures to ensure they are effective, that they remove any residues from the cleaning process itself such as detergents, solvents, etc. They also must address all contaminants and scenarios for equipment use.
How do you actually know when your equipment is clean? Who is responsible for performing your company’s cleaning validations? How are the results approved and when will revalidation be required? These are required components of a cleaning validation procedure and also required in your SOPs.
The detail and specificity of the procedures, both cleaning and validation, will be the key focus of FDA’s investigation. Join EAS independent consultant, Joe McGuiness, for a look at the key steps to validating equipment and common missteps that can lead to adulterated products. Gain valuable insights that you can begin implementing today.
About the Presenter
EAS consultant Joe McGuinness utilizes extensive experience in the pharmaceutical industry to assist EAS clients with preparation for and execution of both internal and FDA audits. He designs protocols for SOPs, GMPs and training programs ensuring an understanding of regulatory compliance requirements and assists with remediation and responses of CAPA findings and deviations. He also helps with the preparation of CMC in support of FDA submissions.