cGMP is in the DNA of BBG
Adrienne Mendoza, Vice President of Global Quality and Compliance, helps BioBridge Global and its subsidiaries ensure cGMP (current Good Manufacturing Practices) throughout every process. She answers the basic question – “What is cGMP?” – and then adds some background in a video:
What is cGMP?
cGMP standards specify how to train personnel and qualify equipment, how to document procedures and facilities within our organization and how to carry out critical functions within every process performed at BioBridge Global. The “current” part of cGMP is an important piece because the standards and regulations around manufacturing processes are constantly changing.
GMPs specify what actions must be taken to ensure products, and their manufacturing processes, are designed and controlled to prevent sources of contamination that could lead to impure, ineffective or unsafe products.
In Quality and Compliance, part of our focus is on continual quality improvement. One example is the redesign of standard operating procedures. Our department includes a Technical Documentation Team, and one of the tasks for technical writers Ryan Connor and Anthony Feole is helping the organization improve the layout and readability of procedures, work instructions and job aids.
Good manufacturing practices were the foundation for the organization in the 1970s, long before cGMP standards were established. Simply put, cGMP is in our DNA.
We process everything through change control. We qualify everything we perform here. We train everybody effectively on every critical process. And we’re constantly looking for ways to improve and enhance our ability to meet the needs of our ultimate customers - patients.
Find out more about Good Manufacturing Practices with Adrienne Mendoza in her video:
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