Tag Archives: Validation

10 Easy Steps – Deleting a Point from a Qualified Building Management System (BMS)

Siemens APOGEE

Hello, good people of the world! This post covers the procedure for deleting a point from a qualified Building Management System (BMS), specifically the Siemens APOGEE® BMS. A template for your use is here: Deleting a BMS Point TEMPLATE.

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Qualifying cGMP Warehouse Space

Warehouse

Hello, good people of the world! So you have a cGMP warehouse you need to qualify? Well, this post will provide plenty of information to get you started.

First, how do you know your warehouse is a “cGMP” warehouse. Well, it is if:

  • The warehouse will house any raw material, excipient, intermediate, or finished product
  • The warehouse will house equipment or process consumables, such as filters, bags, disposable tubing, etc.
  • Any cGMP operations will occur in the warehouse, such as sampling, dispensing, kitting, track and trace, etc.

Any examples of common or even possible non-cGMP warehouse space in the Biopharma industry? Please leave a comment below.

Continue reading Qualifying cGMP Warehouse Space