Design Qualification (DQ) The DQ phase involves verifying that the HVAC system is designed according to the requirements of the facility, production process, and regulatory guidelines (e.g., WHO, EU GMP, FDA). It should ensure that: Room classification: Cleanrooms and controlled environments are designed to meet the required cleanliness level, such as ISO 7 or ISO…
Analytical Laboratory KPIs: Turnaround Time (TAT) Test Completion Rate: Accuracy and Precision: Instrument Uptime: Sample Rejection Rate: Quality Control KPIs: Out-of-Specification (OOS) Rate: Out-of-Trend (OOT) Rate: Deviation Rate: Corrective Action/Preventive Action (CAPA) Effectiveness: Read also: Resource Person: Rajesh Jain
A fishbone diagram, also known as Ishikawa diagram or cause-and-effect diagram, is a visualization tool used to identify and organize potential causes of a specific problem or effect. It’s called a fishbone diagram because of its shape resembling the skeleton of a fish. Here’s how it works: It’s widely used in problem-solving processes, quality management,…
Freeze drying, or lyophilization, is a critical process in the pharmaceutical industry, primarily used to enhance the stability and shelf life of delicate drugs and biological products. This advanced dehydration method allows for the preservation of pharmaceuticals without compromising their efficacy, making it indispensable for high-quality drug production. Understanding the Lyophilization Process Freezing Phase: Initially…
The Deming PDCA (Plan-Do-Check-Act) cycle is a continuous improvement process that helps organizations systematically solve problems and enhance processes. Let’s break down each phase with the provided format: Plan (P) Problem Analysis Goal (Measurable) Do (D) Check (C) Responsibility Act (A) The PDCA cycle is iterative, and after the “Act” phase, the cycle begins again…
“Operational excellence” refers to a philosophy of continuous improvement in an organization’s processes, systems, and culture to achieve sustainable competitive advantage and superior performance. Here are some strategies commonly associated with achieving operational excellence: Continuous Improvement (Kaizen): Encouraging a culture of constant improvement by empowering employees at all levels to identify and implement small, incremental…
Regulators encourage the use of restricted access barrier system (RABS) or isolator technologies. Such settings minimize direct human intervention in a process, reducing the risk of microbial ingress from operators. Transition from a classic design based on grade-A or grade-B cleanrooms to an upgraded facility is not to be taken lightly. Such a project would…
Kaizen is a Japanese term meaning change for the better or continuous improvement Kaizen fosters an environment where employees at all levels are continually involved in suggesting and implementing improvements to their workflows. This approach not only increases efficiency and productivity but also instills a sense of ownership and teamwork among employees, encouraging them to…
