A common basis for grouping is by product.
The grouping is usually based on the formulation or the
dosage form of the product. When this approach is used, the company’s products are divided into
groups according to the dosage form and then according to formulation.
For example, a company might have 10 tableted products, 6 ointment products, and 4 liquid products. In this case, the first
evaluation would be that the products fall naturally into 3 broad groups. However, if 6 of the tableted
products were manufactured by a wet granulation process, whereas 4 of the products were
manufactured by a dry, direct compression method this would be a basis for subdividing the tablet
group into 2 subgroups. Likewise, if 2 of the liquid products were suspensions and the other 2 liquid products were true solutions, this would also create 2 subgroups for this group.
Thus, the hypothetical company would actually have 5 groups of products for cleaning validation purposes.
No comments:
Post a Comment