Change control in the pharmaceutical industry is a systematic approach to managing product, process, or system changes. It is a critical part of quality management in the pharmaceutical industry, as it helps to ensure that changes are introduced in a controlled manner...
Nonconformance means that there was an event with a process, service, or product, and the result does not match the requirements. The cost of nonconformance can be significant, making it crucial for all companies to actively reduce such events. Minimizing...
QMS documentation discussed in this article are documents and records related to compliance and quality assurance. These documents define the company’s Quality Management System (QMS). The QMS documentation is defined by each company based on regulatory and...
Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every...
FDA 21 CFR Part 11 and EU GMP Annex 11 address similar concerns and aim to achieve the same goals, namely data integrity, comprehensive audit trails, limited system access, trained users, and more. However, there are notable differences between these regulations....
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok
