New Products Equipment and Processes

The introduction of any new product, equipment, or process must proceed through ABC Pharmaceutical Company change control procedure No. QABC-001.

Before the introduction of any new product to Manufacturing or the Packaging department, an evaluation is to be made using the following criteria:

• Solubility of active materials in water

• Toxicity of the active material

• Potency of the product

In case of an active material that is already a worst-case designate, concentrations will be compared between the new products and existing products, and the product with the active material in higher concentration will be deemed the "worst case." A new cleaning validation study will be conducted if the new product has been deemed "worst case" by this investigation; otherwise, the existing cleaning validation study relevant to the particular worst-case product and equipment train will prevail.

Similarly, if a new cleaning procedure is introduced, which may impact the cleanliness of the process equipment (e.g., automated CIP procedures or new cleaning agents employed), it will undergo a new cleaning validation study for the relevant worst-case products.

New equipment addition in the production of any products that are not covered within the groupings listed in the CVMP will require a new cleaning validation study for the product deemed worst case on the relevant equipment train.

New products, processes, and equipments will be identified in subsequent revisions of

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