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Cleaning Validation Protocol

I have some query regarding cleaning validation. We mainly involve in tablet production. We do not have cleaning validation protocol or system. we want to do cleaning validation. so please suggest me how to proceed. I appreciate your help and cooperation. I am waiting for your kind response.

Thanking You,
Gobinda Kumar

Set your carryover acceptance criteria based on health care limits (ADE or acceptable daily exposure, a measure of toxicity) for each molecule. Test (swab and rinses) each department (and critical pieces of equipment) based on its drug product contact surface area like dispensing, compounding, granulation, tableting… Remember, it is your cleaning procedure (SOP) that is being evaluated for effectiveness and the test method is the yardstick.


This is a big question, with many parts to it. Cleaning can directly affect the Safety, Efficacy, Strength, Purity, and Quality of a product, and so is a topic of much debate and much scrutiny.

There is too much to this question to answer in one post, and this will take a systematic approach to learn all the aspects.

What do you know already? What do you have in place?

Here are some aspects of cleaning validation that will have to be delved into deeply.
1 - Toxicology of your product (helps determine acceptance limits, see Boomer Chemist’s comment)
2 - Equipment design (sites to test for)
3 - Cleaning method (automatic, or manual, or a combination of both)
4 - Cleaning agents, surfactants, etc.
5 - Chemistry of the product to be cleaned (how hard/easy is it to clean
6 - Interaction between various products (if the equipment is shared)
7 - Types of products to be cleaned (are there various “types” of products
8 - Bracketing approach (is there a worst case product, if there are multiple products)
9 - Batch or campaign cleaning, and how often cleaning needs to be done. How often sampling and testing need to be done.
10 - Sampling methods (swab or rinsate)
11 - Testing methods (TOC, HPLC, pH, or other).

Each of these bullet points deserves a full discussion. So your task is fairly large.

Many of these topics are found within this discussion forum. Here is a quick link to search.


Good luck!

Thank you Boomer_Chemist and JaredCroft for your kind response. I appreciate your cooperation.
I went through some links guided by you. So our cleaning method is completely manual. ADE is required to calculate carryover. So can you suggest me any source where I can get ADE data.

ADE is best found by consulting with a toxicologist externally or internally. Other than that, I would do a literature search online. I cannot be much more help here, sorry.

You can get ADE data from a registered toxicologist at www.affygility.com (costs about $600 USD) or sometimes the EFSA (European Food Safety Authority).

Thank you for suggestion