Understanding the degradation pathway of an API is essential during preformulation study, as it directly influences excipient selection and stability study planning. Forced degradation studies provide insights into how an API degrades under stress (e.g., heat, light, pH, oxidation), helping predict chemical stability and ensuring compatibility with excipients. Key Benefits of Forced Degradation Studies: Degradation…
Several reasons can lead to the rejection of a pharmaceutical batch: Microbial Contamination: Presence of harmful bacteria, fungi, or other microorganisms, especially in sterile products. Out-of-Specification (OOS) Results: Test results, such as potency, dissolution, or assay, falling outside the set quality parameters. Deviations in Manufacturing Process: Unplanned changes or errors during production, such as incorrect…
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…
