Change control is the process of implementing changes to cGMP-related operations and other business systems in a manner that ensures effectiveness and continued compliance.
Change control can be applied to any business system, but in a cGMP context it can be applied to:
Products (formulas, labels, etc.)
Processes (manufacturing processes, test methods, etc.)
Equipment and facilities (rooms, utility systems, process equipment, test equipment, instruments, utensils)
Some changes are routine, such as training new personnel, updating a document, or replacing a simple test instrument such as a thermometer; these changes can be controlled through the establishment of an SOP for each circumstance.
Other changes are not routine, such as installing new major manufacturing equipment or significantly changing a manufacturing process, and need to be evaluated on a case-by-case basis.
During this two-hour teleseminar, which includes a dedicated Q&A session, learn from experts about how to implement and manage change control in compliance with 21 CFR 111.