ISO 15378 – Medicinal Products

ISO 15378 is a standard that sets out the requirements for the proper design, manufacture and supply of immediate packaging materials for medicinal products.

ISO 15378 is related to other standards that should be consulted:

• ISO 9001:5015. Quality management systems.
• ISO 14698-1. Cleanrooms and associated controlled environments. Control of biocontamination. Part 1: General principles and methods.
• ISO 14698-2. Cleanrooms and associated controlled environments. Biocontamination control. Part 2: Evaluation and interpretation of biocontamination data.

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