Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive or detergent ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the

microbial A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...

attributes. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by residues from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a

good manufacturing practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutica ...

requirement. The U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) has strict regulations about cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies. The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design, cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Acceptance criteria for cleaning validation protocols considers limits for chemicals and actives, limits for bio burden, visually cleanliness of surfaces, and the demonstration of consistency when executing the cleaning procedure. Regarding the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. Current expectations for setting cleaning limits include the application of risk management principles and the consideration of Health Based Exposure Limits as the basis for setting cleaning limits for actives . Other limits that have been mentioned by industry include analytical detection levels such as 10 PPM,

biological activity In pharmacology, biological activity or pharmacological activity describes the beneficial or adverse effects of a drug on living matter. When a drug is a complex chemical mixture, this activity is exerted by the substance's active ingredient or ...

levels such as 1/1000 of the normal

therapeutic dose The therapeutic index (TI; also referred to as therapeutic ratio) is a quantitative measurement of the relative safety of a drug. It is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes ...

and

organoleptic Organoleptic properties are the aspects of food, water or other substances that create an individual experience via the senses—including taste, sight, smell, and touch. USDA uses In traditional U.S. Department of Agriculture meat and poul ...

levels. International Society of Pharmaceutical Engineers, ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls. August 2020. ISBN 978-1-946964-31-1

References

{{industry-stub Quality

See also

References