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…
Insightful Thought Leadership
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…
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…
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 for a firm is often a challenging task. Sustaining it can often prove to be even more challenging for upper management.…
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…
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…
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…
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…
In this interview, Dr. James Blackwell, Founder and Principal Consultant of The Windshire Group discusses cell therapy technology transfer "Communication and taking the time to develop…
One of the most dreaded problems in large scale biomanufacturing is contamination events. These events negatively impact an organization in many ways: lost batches and…