Cleaning Validation Matrix and procedure

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear All,
Kindly guide me regarding the cleaning validation matrix.

  1. I am working in a contract manufacturing unit, where i have more than 250 API rolling over a month.
  2. Products are with single ingredients and in combination.

how to design a matrix and what exact method to be followed for cleaning validation.

I’ll appreciate ur response.

2

[quote=sallunaaz]Dear All,
Kindly guide me regarding the cleaning validation matrix.

  1. I am working in a contract manufacturing unit, where i have more than 250 API rolling over a month.
  2. Products are with single ingredients and in combination.

how to design a matrix and what exact method to be followed for cleaning validation.

I’ll appreciate ur response.[/quote]

Dear Mr. Sallunaaz

You can follow the following guideline Page.No:16 and 17, which may provide guidance to prepare the cleaning validation matrix for different products/intermediates.

You can follow the following methods to determine the allowable carry over.

  1. Based on daily dose.
  2. Toxicology data
  3. General limit.

For detailed description follow the attachment.

[attach]328[/attach]

Thanks and regards

pub-cleaning-validation.pdf (240.4 KB)

3

[quote=jyopravel]Dear Mr. Sallunaaz

You can follow the following guideline Page.No:16 and 17, which may provide guidance to prepare the cleaning validation matrix for different products/intermediates.

You can follow the following methods to determine the allowable carry over.

  1. Based on daily dose.
  2. Toxicology data
  3. General limit.

For detailed description follow the attachment.

[attach]328[/attach]

Thanks and regards[/quote]

Should we include the daily dose in the matrix?
What is the purpose of inclusion of daily dose, & what will be the worst: the lowest or the largest daily dose?

4

[quote=Reham]Should we include the daily dose in the matrix?
What is the purpose of inclusion of daily dose, & what will be the worst: the lowest or the largest daily dose?[/quote]

Not required to include the daily dose in the matrix. Cleaning validation matrix routes the essential cleaning requirement of previous product to next product. Eg. Cleaning will be stringent if the change over will be made from finished stage to next product finished state. Matrix explains the cleaning requirement between the change overs.

Daily dose is used to calculate the allowable carryover to next product combine with suitable safety factor.

Worst case will be assigned based on carryover of previous product [in mg]. Lowest carryover of previous product among the products will be considered as worst case. We will not predict the worst case for daily dose, because it will be combined with batch size of the product. Most of the cases lowest daily dose will be the worst case.

5

thanks Mr. Prasad:
Is that mean that I have to add MACO together with toxicity, solubility & cleanability in the matrix? (my confusion is due to APIC reference which include daily dose in the matrix)!!
What if I find one worst case in toxicity & cleanability, & another one in solubility?

6

then you will need to do cleaning validation for worst case in toxicity and worst case in cleanability, some industries follow only worst case in cleanability but now a days auditors are looking into both.Do ensure to look in analytical perspectives also like, swab recovery, AMV, LOQ values. Recovery in differant materials

regards
satish Maddula
satish_ada03@yahoo.co.in