7 Factors to Make a Successful Cleaning Validation

What 7 factors are necessary to make a successful cleaning validation?

Successful cleaning validation has in common the following (7) seven factors:

1. Demonstrate that the process and equipment do as established in the design documents under normal manufacturing operations.

2. A cleaning validation execution can initiate after completed the execution and approval of the Installation Qualification and Operational Qualification activities.

3. The cleaning validation must be executed by experienced and trained power users as the system is being tested and released.

4. The cleaning validation protocol(s) should be approved before protocol execution to comply with the prospective validation approach.

5. A copy of the unexecuted protocol should be kept in the validation package.

6. The unexecuted protocol should be approved at least by the protocol author, system owner, and quality assurance representative.

7. The final report of the executed protocol should be signed at least by the tester and reviewed by the system owner and quality assurance representative.

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HOW TO PREPARE A VALIDATION PROTOCOL IN 24 STEPS?

HOW TO WRITE A CLEANING PROCESS PROCEDURES IN 6 STEPS.

THE TOP ANALYTICAL METHODS USED

PREFERRED TEST METHODS

CONSIDERATIONS TO SELECT THE CORRECT TEST METHOD

SAMPLING

TOP CLEANING VALIDATION FACTORS AND LEVELS 

ESTABLISHMENT OF ACCEPTABLE CRITERIA

STATUTORY AND REGULATORY REQUIREMENTS

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Three (3) options to create a qualification protocol:

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

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

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

In addition, you can request a quotation to buy online a full validation 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 your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation 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 a customized qualification.

One of our expert(s) will create and prepare for you a customized validation protocol 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