ASTM E2500 Example

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ASTM E2900 was introduced to the pharmaceutical industry more than ten years ago. Conventional wisdom suggests that with a standard so old, pharmaceutical companies must already be leveraging it to greatest advantage, but this is not the case.

Poor communication of user requirements, often created through organizational silos between Process Development (R&D), Manufacturing/Production, and Engineering, frequently results in equipment that meets specified requirements, but may not be suitable for the intended use.

Streamlining results from involving all parties in an up-front user requirements process, emphasizing on QbD (Quality by Design) to develop the Facilities, Utilities, Software and Equipment (FUSE), through focus on intended use.

The organization can then realize greater success from a shortened lifecycle for equipment qualification, process development, process validation and, ultimately, product launch. By anticipating operator and process needs, use of the ASTM E2500 standard reduces validation testing, while at the same time averting undesired last-minute delays.

Compliance Team can help you integrate ASTM E2500 in your technology transfer program.   Get started by downloading this free ASTM E2500 example documentation or contact us to find out more about our technology transfer and validation services.