Specific

Cleaning validation studies will be conducted for products/processes representing worst-case scenarios. Validation of the worst-case matrix ensures that the current cleaning practices at ABC Pharmaceutical Company are robust and

• Reduce the risk of cross-contamination

• Minimize the potential for product spoilage through microbial contamination

• Minimize the potential for adverse effects in consumers

Your Company's L

Your Company's L

Your Company's N

Your Company's N

The following criteria will be used to select the process and/or product over which the study shall be performed:

• Solubility of raw materials in the product, specifically the combination of least soluble product in water (the cleaning agent) and largest concentration to which the particular product occurs.

• Potency of the product (therapeutic dose).

• Toxicity of the active ingredient in the product, specifically the combination of most toxic ingredient and largest concentration to which the particular product occurs, as applicable.

• Most difficult product residue to clean, based on experience.

• Coverage of all equipment through each train. Equipment will be grouped based on elements of similar design/surface composition, if the same cleaning procedure is used for all sizes. Equipment that utilizes different cleaning techniques should be noted and rated accordingly.

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