Regulatory Update | Preparing for an FDA Inspection

FDA Inspections and Cleaning

BY Anita R. Michael, Principal Consultant and Pamela Aiello, Senior Consultant, Regulatory & Access, Parexel - 1.23.20 -

Companies often have many questions concerning their approach to cleaning validation when it comes to preparing for an FDA Inspection.  Often cleaning validation studies are extensively reviewed and assessed during FDA Inspections.  How can you prepare your firm to be inspection ready when it comes to cleaning validation?

Below are some helpful questions to help you prepare and be ready for your next inspection.

What are the cGMP regulations regarding cleaning validation requirements?

Cleaning validation is a critical aspect of pharmaceutical manufacturing and required per the cGMPs 21 CFR 211.42 and 21 CFR 211.67.  When designing and building of your manufacturing facility, companies should consider floor plans, flow of materials, type and build of equipment as well as people and employee operations when it comes to designing cleaning validation.  These design reports should be available for review during your inspection.

Is your equipment shared dedicated or both?

Companies often question how to approach shared and or dedicated equipment processes. The cGMP regulations require equipment whether dedicated or multipurpose be cleaned and maintained as appropriate.

Equipment depending on types of products produced at your facility and whether shared or dedicated need to be sanitized and or sterilized to ensure there is no contamination or impact on the quality of the pharmaceutical products.  Records of such cleaning activities are to be kept as part of cGMP requirements and available for inspection.

Manufactures should have robust cleaning procedures that are well defined, well documented and scientifically supported with cleaning validation studies.  Thorough cleaning validation studies include the development of cleaning procedures by Research and Development groups, validation of cleaning procedures by Technical or Quality groups, training of employees and the application of Cleaning Processes by Operations and Manufacturing organizations.

Residues What are the Expectations?

Common areas of concern when approaching cleaning validation are ensuring residues are removed.  For example, active ingredients and cleaning agents.  Residues should be adequately removed from product contact surfaces of equipment.  Types of equipment surfaces also should be examined and considered your cleaning validation studies.  

For cleaning validation to be successful, the studies should ensure residues are effectively removed from product contact surfaces and test methods need to be proven effective.  Additionally, equipment sampling procedures for swabbing and rinse samples should be approved by quality and the methods should be validated.  Equipment should be as clean as can be reasonably achieved to a residue limit that is safe, causes no product quality concerns and leaves no visible residues.

Cleaning Validation and Continued Process Verification Stage 3:

As part of Guidance for Industry Process Validation: General Principles and Practices January 2011 Current Good Manufacturing Practices (CGMP) Revision 1, during Stage 3 ― Continued Process Verification, the equipment and facility qualification data should be assessed periodically to determine whether re-qualification should be performed and the extent of that re-qualification. 

This relates also to cleaning validation studies for pharmaceutical equipment.  For instance, if new products or equipment parts are added to existing manufacturing process, changes in formulations or cleaning agents, cleaning validation studies and procedures should be evaluated to determine the risk associated with such changes.

These changes should be documented and managed through the company’s change control management, risk assessments and as part of the company’s Quality System.


Cleaning Validation is an ongoing process and should be maintained throughout the Life Cycle of the Products and Facility Design.


Guidance for Industry Process Validation: General Principles and Practices January 2011 Current Good Manufacturing Practices (CGMP) Revision 1

FDA Questions and Answers on Current Good Manufacturing Practices -Equipment August 4, 2004

Review: The Review of American Pharmaceutical Business and Technology Volume 17 Issue 5 July/August 2014; Article How Clean is Clean in Drug Manufacturing? By Igor Gorsky; Accepted for publication 07/28/2014

21 CFR 211.42 Design and Construction Features

21 CFR 211.67 Equipment Cleaning and Maintenance

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