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Validation

Verification vs. Validation: Using a Transdermal Patch to Explain the Difference

The terms validation and verification are used in many industries. In this post, we are referring to them in the context of the converting industry,…

Validation Essentials: Three Must-Dos to Achieve Compliance Validation Essentials: Three Must-Dos to Achieve Compliance

Good Automated Manufacturing Practices (GAMP) are the guidelines for manufacturers and users of automated systems in the pharmaceutical industry. Because of the regulatory nature of…

FDA Mandate on UDIs to Impact Medical Device Manufacturing How FDA Mandate on UDIs Will Impact Medical Device Manufacturing

All devices as defined by 21 USC 321 (h), i.e., a “medical device,” are subject to the requirements of the UDI rule unless an exception…