Product Grouping
For the purpose of cleaning validation a group of related products to be identified and a single
product selected as worst-case or representative of the product family The rationale for the
grouping must be documented. Types and examples of product grouping include:
Figure 1: Types and examples of product grouping
Once products are appropriately grouped, the worst-case product or products can be selected
from among the group for the purpose of executing the cleaning validation protocol. A number
of scenarios are possible:
· Within a group, two or more products may be determined to provide an equivalent
worst-case challenge to the cleaning procedure. Once the rationale for equivalency
has been documented and approved by the Quality Authority, the equivalent products
are used to demonstrate the effectiveness of the cleaning procedure during validation.
· Example: Product A and Product C are established as equivalent worst-case
challenge products for the cleaning procedure used for products A, B, C, D and E.
During validation, any lot combination of Products A and C are used to fulfill the 3 validation
cleanup requirement (e.g. 3 of A or C, 2 of A and 1 of C or1 of A and 2 of C).
Within a group, two or more products are determined to be worst-case
challenges, but are not equivalent. Each worst-case product should be subjected to
the 3 validation cleanup requirement.
The same cleaning procedure is used for two or more groups of products. Each
worst-case product within each group should be subjected to the 3 validation
cleanup requirement, unless a rationale is documented and approved by the
Quality Authority that the worst-case product of one particular group is clearly a
worst-case product for all groups.
Other scenarios may be possible and each product, or any new product introduced
to the site, should be evaluated on a case-by-case basis.
The criteria that should be considered when selecting a worst-case product or products include:
Solubility of the residues in the cleaning agent, including cleaning and rinse
solvents - the least soluble residue among a group is the most common approach.
Ease of removal by a detergent, if applicable.
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4 comments:
Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation.more information
The exact same cleaning process is utilized for a couple or more groups of paint products. Eachworst -case product within any single group must be subjected to the 3 validation cleaning requirement, except if a rationale is recorded and also approved by the Standard Authority which the worst-case product of one group is clearly a worst-case product for every one of the groups.
more information
Verification and validation techniques applied throughout the development process enable you to find errors before they can derail your project.
they are involved in lot of process improvements which will actually help the clients to deliver best software.
software validation
Written cleaning procedures should be established. Attention should be addressed to dedicate certain equipment to specific products,
such as fluid bed dryer bags and to residue originating from the cleaning detergent or solvent themselves.
By packaging equipment I am referring to primary packaging equipment.
equipment validation
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