Worst Case Product Selection Matrix

The Product Equipment Grouping Matrix lists the products manufactured in the Manufacturing and Filling areas.

The selection of worst-case products is conducted in the following manner:

1. Worst-case products will be selected for each equipment train.

2. For each equipment train, worst-case product(s) will be selected such that a. A cleaning validation study would be performed for the bulk batch product containing the least soluble material.

b. A cleaning validation study would be performed for the bulk batch product containing the most toxic and potent material, if this product differed from that chosen in part a above.

Your Company's L

Your Company's L

Your Company's N

Your Company's N

c. A cleaning validation study would be considered for every product deemed "hard to clean" by production staff following the production of bulk batches. The difficult-to-clean bulk batches are indicated in matrixes and include their rationale for inclusion in the cleaning validation program.

d. Wherever possible, the criteria in a, b, and c will be combined to select one worst-case product representing all scenarios.

3. The list of defined equipment trains is included in Matrix II.

4. Products manufactured on each train are indicated in Matrix III.

5. Solubility data for all active/excipient materials will be gathered and tabulated.

6. Toxicity data for all active materials will be gathered and tabulated.

7. Products will also be examined for raw material ingredients of high toxicity and

8. Members of the production staff were also consulted for their experience in cleaning.

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