Tag Archives: Qualification

Design Qualification (DQ)

Design

Hello, good people of the world! How to define DQ? One way: DQ = documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose Continue reading Design Qualification (DQ)

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