How to Write a Cleaning Procedure in 6 steps

In this article, you will learn how to create a cleaning procedure in 6 steps.

The cleaning procedure is the core center of any cleaning validation. It is the most important element to consider in cleaning process efficacy, specifically in large systems that may employ semi-automatic or fully automatic clean-in-place (CIP) systems since they represent a significant concern.  Therefore, the specificity of the cleaning procedure being validated must be examined in conjunction with the design documentation.  Learn how to write a cleaning procedure according to the FDA expectations 21 CFR 211.67.

Step 1. Document the critical cleaning steps even then simple or complex cleaning procedures are required.

Step 2. The cleaning procedures must include specific documentation on the equipment itself which includes information about who cleaned it and when is valuable.

Step 3. However, for relatively simple cleaning operations, the mere documentation that the overall cleaning procedure was performed might be sufficient.

Step 4. The history of the cleaning procedure, residue levels found after cleaning, and variability of test results may suggest the amount of documentation required.

Step 5. The cleaning procedure must consider when variable residue levels are detected following cleaning, particularly for a process that is believed to be acceptable, one must establish the effectiveness of the process and operator performance.

Step 6. When operator performance is deemed a problem, evaluation, and investigation with more extensive documentation (guidance) and training may be required to improve the cleaning procedures and the operator’s results.

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HOW TO WRITE A CLEANING PROCEDURES IN 6 STEPS.

THE TOP ANALYTICAL METHODS USED

PREFERRED TEST METHODS

CONSIDERATIONS TO SELECT THE CORRECT TEST METHOD

CLEANING SAMPLING

TOP CLEANING VALIDATION FACTORS AND LEVELS 

ESTABLISHMENT OF ACCEPTABLE CRITERIA

STATUTORY AND REGULATORY REQUIREMENTS

For more details on specific FDA expectations and successful cleaning procedures, follow us

Three (3) options to create a cleaning procedure:

Prevent the most common mistakes to avoid during the cleaning process.

Option 1. You can create a great procedure, using a template.

You can download a free sample of a procedure template in .pdf format. 

To see the complete list of the most popular procedure templates, click here.

In addition, you can request a quotation to buy online a full procedure template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We can bring you a formal training on how to create a cleaning procedure

using our template(s).

This option is recommended if you want to learn more about how to build a robust cleaning procedure. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build reliable cleaning procedures using a template. You can improve your corporate cleaning procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create customized procedures.

One of our expert(s) will create and prepare for you a customized cleaning procedure with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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References

PIC/S Guideline to Validation – PI -006-3 (2007)

ICH Guideline Q7 “GMP for APIs

Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/validation-cleaning-processes-793

httpss://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment

httpss://www.gmp-compliance.org/gmp-news/what-does-the-fda-expect-from-cleaning-validation-today

httpss://gmpnews.net/2019/06/fda-requirements-for-cleaning-validation/

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/contamination-control-cleaning-validation.pdf?sfvrsn=4