Ruggedness of Visible Residue Limits for Cleaning Validation
This week, Stacey chats with Rich Forsyth about understanding how the results of testing, and reproducibility of test results under varying conditions allows for consistency across teams and lessens the risk of error in cleaning validation activities. Visual inspection of equipment has always been an important element of the cleaning validation program. Establishing visible residue limits is extremely valuable in setting a baseline for cleanliness, highlighting viewing conditions, and defining a methodology for performing routine checks on cleaning validation procedures.
Resources for this episode:
- Richard J. Forsyth; Ruggedness of Visible Residue Limits for Cleaning Validation, April 2, 2016, Pharmaceutical Technology
- FDA Cleaning Validation Guideline from CFR 211.67
- Questions and Answers on Current Good Manufacturing Practices—Equipment
- EMA Cleaning Validation Guideline on setting HBELs
- QnA on the implementation of the above guideline
- WHO good manufacturing practices for active pharmaceutical ingredients
- Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation
- PIC/s Aide-Memoire: Inspection of Health Based Exposure Limit (HBEL) Assessment and use in Quality Risk Management
- Health Canada Cleaning Validation Guideline
About our guest:
Rich is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades. He has been involved with Cleaning Validation for over 20 years. Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.
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