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Change Management, especially related to a medical device’s design, is one of the most commonly cited issues in FDA 483s...
Disinfectants must be qualified on the surfaces in a pharmacopeial-manufacturing environment prior to their use in the facility. Building a...
The Universe of Extractables (and potential leachables) is extremely diverse. The reason for this is that there are many different...
With the implementation of ISO 19227:2018 Implants for surgery – Cleanliness of orthopedic implants – General requirements, evaluation of residual...
When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), one of the obvious questions is How far...
