Cleaning validation should have a policy designed to meet harsh regulatory requirements and principles

Compliance with the required cleaning validation regulatory compliance guidelines set out by the regulatory authorities such as the FDA, WHO, PIC/S and EU is essential for those who work in facilities which involve cleaning.

The reason for which adherence to these regulatory guidelines is necessary is that these cleaning procedures need to establish and demonstrate verifiable standards of hygiene and safety. Quite naturally, cleaning validation regulations are built on highly rigorous, exhaustive and challenging principles.

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Many approaches and requirements

Sound scientific principles and practices should be the basis for regulatory guidelines for cleaning validation. Cleaning validation, being risk based and reasonable, should consist of informed decision-making and thorough activity planning.

To comply with cleaning validation regulatory guidelines and scientific principles; very precise concepts such as how to determine the residues to be targeted, ways by which to select the right analytical and sampling methods, how to determine the appropriate limits in various pharmaceutical and biotechnology processes and knowing by what means to establish scientific rationales that are acceptable to regulatory inspectors, need to go into cleaning.

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Lots of processes need to go into cleaning validation

These concepts should ideally lead to the development of a general policy, i.e. a “Cleaning Validation Master Plan”, into which the appropriate documentation for each study needs to be performed. Awareness of the requirements for maintenance of the validated status is necessary for those in charge of the cleaning validation program. They have to also keep the regulatory requirements and the latest industry practices in mind.

Clarity on all these topics is the intent of a detailed, two-day learning session on the topic, “Regulatory Requirements and Principles for Cleaning Validation”, which is being organized by GlobalCompliancePanel, a well-known provider of regulatory compliance trainings. To participate in this seminar, simply log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900635SEMINAR?regulatory-requirements-Washington-DC.

The Director of this learning session, Joy McElroy, Principal Consultant at Maynard Consulting Company, will clear all the doubts regarding cleaning validation and all its elements. Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification during the over 20 years of total experience she has had in the pharmaceutical and biotech industries, 12 of which have been as a consultant.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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