In highly regulated environments, Change Control is vital for ensuring product quality and compliance with stringent regulations. Regulatory Rquirements FDA: EMA: ICH Q10: Types of Changes: Classification of Changes: Key Components of Change Control: Roles and Responsibilities: Best Practices: Read also: Resource Person: Alaaeldin Rashad
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,…
Problem Statement: The hydraulic pressing machine’s malfunction disrupted the assembly line. Root Causes: The pump failed because its filter was clogged and wasn’t cleaned regularly Evidence/Data/Fact: Solution Idea Corrective Action Preventive Measures Read also: Resource Person: Poonath Sekar
Errors are not a reflection of individual incompetence but a result of complex interactions between human factors, system design, & environmental influences. We must abandon the naïve belief that BETTER TRAINING will MAGICALLY ERASE ERRORS and instead embrace a holistic approach. The CAPA framework focuses on both PREVENTION and REACTION to errors: PREVENTION: BUILDING A…
Risk assessment plays a crucial role in the pharmaceutical industry due to its impact on public health, regulatory compliance, and business success. Here are some key points highlighting its importance and impact: Patient Safety: Risk assessment ensures that pharmaceutical products are safe for consumption by identifying and mitigating potential risks associated with their development,…
Managing deviations and investigations efficiently is critical to ensuring product quality, compliance with regulations, and continuous improvement. An effective quality management system (QMS) must include procedures to identify, document, segregate, evaluate, and disposition production and post-production issues. You need to report and document the deviation as soon as it is identified. This includes…
Hazard and Risk are two important concepts in the pharmaceutical industry, but they have distinct meanings and implications. Here is a comparison between hazard and risk in the context of the pharmaceutical industry: 1. Definition Hazard: A hazard refers to any potential source of harm or danger that can cause adverse effects on human…
There are several quality risk management trends in the pharmaceutical industry that have emerged in recent years. These trends aim to improve the overall quality and safety of pharmaceutical products and processes. Some of the key trends include: 1. Implementation of Quality by Design (QbD): QbD is an approach that focuses on building quality…
