Change Control: General Points to Consider
The following is an excerpt taken from The Windshire Group's webcast "Implementing a Change Control Quality System Successfully Expert Panel Discussion - Live FREE Webcast"…
Cell Therapy Process Manufacturing and Quality
The following is an excerpt taken from The Windshire Group’s webcast “Cell Therapy Expert Panel Discussion”: Dr. James Blackwell: It will not be business as usual. Sloppy…
Is there a requirement what needs to be included the batch record?
The following answer to the question “Is there a requirement what needs to be included the batch record? I am asking from a standpoint, if…
What if I have a component that is a critical piece of the process, but there is only one supplier that can provide it, and they recently failed their supplier audit?
The following answer to the question “What if I have a component that is a critical piece of the process, but there is only one…
What are the areas of greatest risk for data integrity issues?
The following answer to the question "What are the areas of greatest risk for data integrity issues?" is taken from The Windshire Group’s webcast “GMP Data…
Building a Quality Culture: Management Understanding QMS “State of the Union”
Building a quality culture for a firm is often a challenging task. Sustaining it can often prove to be even more challenging for upper management…
Computer System Validation- How Early in Product Development?
We are sometimes asked how early in development companies need to start worrying about computer system validation? While predicate rules do not directly answer this…
Critical Considerations in the Design, Fabrication, and Integration of a Clean-in-Place System
This discussion features the design, fabrication and integration of Clean-In-Place (CIP) systems. CIP is used in the food, beverage, biotech and pharmaceutical industries. CIP is…
Correction, Corrective Action and Preventive Action Defined
Corrective and preventive action are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set…
Always Follow Your SOPS! Upholding Gowning Requirements When Challenged by Inspectors
Regulatory inspections can be a stressful time for all involved. You may encounter some situations in which you are challenged by an investigator that goes…