Cleaning Validation

Can anyone send me articles related to matrixing (grouping) of products in multi-product facility for cleaning validation.

Suppose if following are the list of products:

  1. Glyburide and Metformin Hydrochloride Tablets
  2. Lovastatin Tablets
  3. Metformin ER Tablets
  4. Valacyclovir HCl Tablets
  5. Gliclazide modified release tablets
  6. Losartan K Tablets
  7. Losartan K and Hydrochlorothiazide Tablets

Among the above products, Glyburide is the worst case let us consider as product A.

So as per dose criteria formula:
Calculation of Maximum Allowable Carryover (MACO):
MAC =(LTD{A} x SBSB x SF)/MDD{B}
Where,
MAC - Maximum allowable carryover
LTD - Lowest therapeutic dose of any product manufactured (product manufactured, A)
SBS - Smallest batch size of the any product manufactured in equipment train. (Subsequent product, B)
SF - Safety factor 1/1000 for solid oral dosage form
MDD - Maximum daily dose of any product manufactured in equipment train. (Subsequent product, B)

If we consider product A as Glyburide what will be the product B?

Can you please anyone help me in this?

My mail id: sureshmpharm@yahoo.co.in

Dear sureshmpharm,

to choose the “product B”, you need to provide the figures for SBS and MDD, assuming that the equipment train is identical for all the products in the list. The “product B” will be the one has the smallest factor (SBS/MDD), because it will render the most challenging MAC.

Best regards

Alfred