One function of these protocols is to document the original installation conditions; and a second important function is to demonstrate that the equipment is suitable for the task to which it is assigned. The protocols need to be organized, easy to follow, and must “test” each major component or operation as it would impact the process. The IQ and OQ protocols are often referred to as “water runs.” This is because the product need not be used in any of the tests (there are some exceptions, eg, high viscosity available only in the product).
The above IQ and OQ tests can be lumped together into usable categories necessary to demonstrate effectiveness of both construction and operations such as:
• Materials of construction—the materials, according to 21 CFR 211.65, “… shall not be reactive, additive, or absorptive so as to alter the safety, strength, quality, or purity of the drug product …” In addition it goes on to refer to the lubricants or coolants used should not interfere with the drug product. Thus, the use of food grade lubricants is considered standard practice.
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