An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.
CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.
The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.
The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.
This article presents the requirements regarding documentation of QMS procedures and work instructions and then introduces methods that can be used to effectively document compliant procedures.
Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization.
For a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation.
Properly identifying outliers can assist companies with the proper establishment of trending and excursion limits for complaint and nonconformance management and other aspects, which can trigger investigations or initiate the formal CAPA process.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking.