Learnaboutgmp Community

Worst case assessment

Hello dear members,

I am currently working on implementing a validation master plan in a pharma company that produces vials and bottles of severals active ingredients (from Morphine to vitamines and salts).
We have picked 4 criteria to rank all the product per process train.

However i have a doubt. I have the choice to add up all the marks and get my worst case product or create a geometrical representation on excel with each criteria on each axes. Then it will lead to the selection of several products in order to represent the widest surface area. Are they any member familiar with this technic?
Which way do you use it?

Thanks in advance

Thomas

[quote=physeter]Hello dear members,

I am currently working on implementing a validation master plan in a pharma company that produces vials and bottles of severals active ingredients (from Morphine to vitamines and salts).
We have picked 4 criteria to rank all the product per process train.

However i have a doubt. I have the choice to add up all the marks and get my worst case product or create a geometrical representation on excel with each criteria on each axes. Then it will lead to the selection of several products in order to represent the widest surface area. Are they any member familiar with this technic?
Which way do you use it?

Thanks in advance

Thomas[/quote]

Dear Thomas,
please be more specific. To which kind of validation - qualification are you refering to? Is is cleaning, or performance qualification?

Best regards,

Sorry i was in such a hurry that i ommited to mention that i was talking about cleaning validation of course. I would love to get in touch with someone that had experience in cleaning validation with liquid process.

Thanks again

Thomas

[quote=physeter]Sorry i was in such a hurry that i ommited to mention that i was talking about cleaning validation of course. I would love to get in touch with someone that had experience in cleaning validation with liquid process.

Thanks again

Thomas[/quote]

Dear Thomas,
ok. I assume we are talking about sterile solutions. What I would do if I were in your shoes.

I would generate a table of all my products involved in my evaluation. I would also nclude in this table all the equipments that the manufacturing of each product requires.

According to this table I would separate my products in groups which groups I would choose depending in the separation of the involved equipment in Lines (For instance Compounding Tank1, Holding Tank1, Housing Filter1, Filling line1 = Line1/Groupof products 1, Compounding Tank2, Holding Tank2, Housing Filter2, Filling line2 = Group of products 2 etc.)

Therefore I would be based on choosing the worst case product by each Line and evaluate my cleaning process for each Line using the worst case product of each group.

Hope this helps.

Best regards,

Thanks for the reply. However, if you refer to my first post, this is not exactly the core of my question. What i am looking for is to decide whether to add up the marks of my criteria (dosage, cleanibility…)when selecting the worst case or do another technic (graphical representation)

Thanks again

Worst case depends on following points…

1.solubility of drug in water
2.potency
3.MAR value.
4.train of equipment used

PRASAD

[quote=physeter]Thanks for the reply. However, if you refer to my first post, this is not exactly the core of my question. What i am looking for is to decide whether to add up the marks of my criteria (dosage, cleanibility…)when selecting the worst case or do another technic (graphical representation)

Thanks again[/quote]

Hallo,
I would advice you to add up the criteria used to select the worst case product.starting with the most significant down to the least significant. in this case 1)solubility, 2) concentration in bulk (could be excipient or active depending on the substance, 3) concentration per dose (same as in 2), 4) toxicology data of the material concerned 5)train of the equipment.
It goes without saying that the criteria for selecting worst case is the most practical and i would not advice you to delve into graphical representations which creat more questions on the efficiency of the cleaning process.
thank you

Kenneth Nyongesa

We have just finalised our rating. We added up all the “chemical” ratings for each category, and then extrapolated it against a measure of the product’s “cleanability” (ease with which produt is cleaned) using a simple grid. Most equipment in our facility is shared for the majority of processes, so line grouping was not an option for us. I was only able to group at the granulation phase, and even then it was a bit of a problem. Based on the grid, any product which came up as a “High Risk” rating was selected for our studies. All other products, once the Cleaning Validation is completed for the selected products, will be subject to visual evaluation, with TOC of a rinse sample.