What is Cleaning Validation?

What is cleaning validation

 

Was validated correctly your cleaning process?

Many people do not understand clearly what is cleaning validation. Sometimes, they confuse its purpose assuming that the intention is to remove 100% of all residues present.

Instead, the cleaning validation aims to establish that a predetermined sanitization process and procedure are capable to reduce the chemical and microbial residues below safe acceptance criteria.

Indeed, the cleaning process aims to reduce the amount of the active, inactive, or detergent ingredients of the product manufactured in a piece of equipment, including the detergents utilized in the process considering cytotoxicity levels and No Observed Adverse Effect Level (NOAEL).

What is the No Observed Adverse Effect Level: (NOAEL)

The NOAEL is defined as the greatest concentration or amount of a substance found by experiment or observation which causes no detectable adverse alteration of morphology, functional capacity, growth, development, or life span of the target organism under defined conditions of exposure.  To learn more about NOAEL click here.

Most cleaning validations usually covers the following seven (7) aspects:

  1. Equipment design,
  2. Surface Material
  3. Cleaning procedures and parameters,
  4. Analytical methods and detection limits
  5. Sampling plan.
  6. Detergents
  7. Product or residues to be removed

It shall provide the scientific data to support that the cleaning process consistently does as expected and produces a result that consistently meets predetermined specifications.

SUBSCRIBE AND FOLLOW US TO LEARN MORE ABOUT  

WHAT IS CLEANING?

WHY CLEANING VALIDATION?

WHEN IS REQUIRED A CLEANING VALIDATION?

WHAT 7 FACTORS MAKE A CLEANING VALIDATION SUCCESSFUL?

HOW TO PREPARE A VALIDATION PROTOCOL IN 24 STEPS?

12 ELEMENTS TO CONSIDER DURING A SUCCESSFUL CLEANING VALIDATION

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

FDA EXPECTATIVE TO CLEANING VALIDATION 21 CFR 211.67

STATUTORY AND REGULATORY REQUIREMENTS

More details on specific FDA expectations can be found in the guidance document below.

httpss://www.iso.org/standard/53394.html

For a preview, refer to httpss://www.iso.org/obp/ui/#iso:std:iso:14644:-1:ed-2:v1:en

validation templates online

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.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

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

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!