What is included in the definition of "Manufacturing" as per the regulatory guidelines?

The definition of "Manufacturing" according to regulatory guidelines broadly encompasses various activities related to drug products and devices, which include the packaging or repackaging of a drug or device. This aspect is critical because packaging and repackaging can affect the safety, efficacy, and integrity of drug products, as they involve putting drugs into appropriate containers or altering their presentation for dispensation and use. This definition recognizes that manufacturing is not limited to the initial production of a drug but also includes subsequent steps that prepare the drug for delivery to consumers.

On the other hand, focusing solely on the production of new drugs does not encompass the full range of activities associated with manufacturing. Additionally, exclusive handling of drugs during transport is related to logistics rather than the manufacturing process itself. Lastly, the sale of over-the-counter devices pertains more to distribution and retailing rather than the manufacturing aspect as defined by the guidelines. Thus, the packaging or repackaging of drugs or devices is a fundamental component of the manufacturing definition.