The last few decades have seen incredible innovations in manufacturing technology. Everything from 3D printing to robotics to nanotechnology has been developed and refined at an astonishing rate. And yet, for all of this progress, there are still many aspects of manufacturing that are done in exactly the same way they were a hundred years […]
Climate Change, poverty, and mental illnesses depict that markets and governments cannot solve our key problems without community engagement. The first thing that a community professional needs to know are how to establish a meaningful relationship with the community s/he wants to serve. Professionals and communities possess two different types of knowledge: technical and social. […]
Pharmaceutical manufacturing is a highly regulated industry in which cGMPs (current Good Manufacturing Practices) must be followed in order to ensure the safety and efficacy of drugs. Writing an effective cGMP guide can be a daunting task, but there are a few key points to keep in mind that will help you create a document […]
Failure mode and effect analysis (FMEA) is a technique used to identify the risk of failure in a product or process during design, manufacture, and service. It’s also referred to as Failure Modes Analysis (FMA), Factor Failure Analysis, and Failure Cause Analysis. It’s an easy way to highlight potential issues with your product or process […]
A quality management system (QMS) is a collection of business processes and resources focused on achieving customer satisfaction by meeting customer requirements. It is a formalized system that documents and controls how your organization manages important processes to ensure quality. Implementing a QMS provides your business with a structured approach to quality management and continuous […]
The Corrective and Preventive Actions (CAPA) effectiveness review and acceptance process is an important part of an organization’s quality management system, and helps to ensure that CAPAs are designed and implemented effectively. This process can also help to identify potential improvements to an organization’s quality management system. Review and acceptance are crucial to the process […]
Risk-based inspection (RBI) is a methodology that is based upon the concept of rating manufacturing sites on the basis of an estimated risk that they may pose to patients and consumers of medicines. The idea is that by identifying and assessing the risks posed by different manufacturing sites, regulatory authorities can better focus their resources […]
Q1: What are some common issues that can arise with outdated equipment? Answer: One common issue that can arise with outdated equipment is that it may not meet current safety standards. This could pose a safety hazard to both workers and customers. Additionally, outdated equipment may be less energy efficient than newer models, costing more […]
Q1: What are the key elements of a successful quality review? Answer: There are four key elements of a successful quality review: 1) an accurate and up-to-date product specification; 2) a robust testing program that can identify potential quality issues; 3) a strong quality management system that can quickly address any identified quality issues; and […]
Q1: What is the process of pharmaceutical development? Answer: The process of pharmaceutical development is the process of designing, testing, and manufacturing drugs that are safe and effective for human use. The process of pharmaceutical development includes product development, technology transfer, commercialization and scale up. Read moreHow to Understand and Analyze the Root Cause? – […]
