Choosing the worst-case product and the 10ppm rule

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hello,

I have 2 questions about cleaning validation in my OSD production line:

Question 1
Our approach on choosing the worst-case product is based on Risk Priority (= Solubility index x toxicity index). My question is that, in my case, there exists: Product A: 25 (Solubility 5 x Toxicity 5) and Product B: 21 (Solubility 7 x Toxicity 3). Which one should I choose as the worst-case product?

Question 2
My current approach on determining the chemical residue limit is based on the following equation:
Equation 1: LSP = Safety Factor x lowest daily therapeutic dose of API / highest max daily dose of drug product
if LSP < 10ppm, then the chemical residue limit is set as:
Equation 2: limit (in ug/cm2) = LSP (in equation 1) x smallest batch size x recovery factor / surface area
Since i always found LSP is much less than 10ppm (i.e. around 0.2 ~ 0.5ppm), I just wondered whether my concept is wrong.

Many thanks for all your reply.

2

Dear Stanley…

While choosing worst case product, you need to consider potency also. pls look into slide number 36 to 42 of the attached presentation for more information [attach]513[/attach]

Residue limit can be any value more than zero. it depends on your product characteristics.

MACO = [Lowest SINGLE dose of API (previous product) x smallest batch size of next product x safety factor] / maximum DAILY dose of next product

Swab Limit = [MACO x recovery factor ] / [product contact surface area x 100]

RAJU

managing risk in cleaning validation.pdf (382.7 KB)