While the goal of pharmacovigilance remains constant, the methods, resources, and regulations that are designed to reach this goal are continuously being updated and optimized. Adding to this inherent complexity, pharmacovigilance also involves the coordinated interaction of multiple players, including patients, healthcare professionals, pharmaceutical companies, and multiple regulatory authorities across various regions.
A compelling read that at times is light hearted and funny, 7 Habits of Quality Obsessed Manufacturers is written for top performing quality professionals that want to give their company an edge. The ebook takes a closer look at: • How to brag about quality • What successful manufacturers have in common with Einstein • Who plays the starring role in your company • How to not make easy hard • Making the cloud your answer to supply chain visibility • How to choose between "do something" and "do nothing" • Giving data an afterlife
This free white paper, 5 Must Have Strategies for Enterprise Quality, shows how quality can take a more prominent, enterprise-scale role. Learn more today about • The trend towards centralizing quality data • Best practices for collecting and integrating multiple data sources • How to monitor and analyze quality real-time • Workflow management to ensure data integrity • Reporting needs of users at all levels
Total Organic Carbon (TOC) analyzers are utilized across a wide range of industries for such measures as process and water quality control, experimental research, and EPA compliance. Within the pharmaceutical industry, they serve vital roles in the manufacturing process. From inspections of the water used in drug manufacture (ultrapure water) to evaluation of cleaning effectiveness (cleaning validation), TOC analyzers are essential instruments in the pharmaceutical laboratory to ensure compliance with applicable regulations. This paper examines their use and presents some application data.
This article shows excerpts from recent 483s issued for deviations in tracking and recording environmental parameters in various applications, then outlines ten best practices of a 483 response, providing a checklist to make the 15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.
Too often the coating of parts is an afterthought for design engineers. Rather than being a part of the discussion in the early stages of design, designers try to solve problems with coatings at the point of manufacturing – or even after manufacturing. While each type of surface treatment (anodizing, electroplating, thermal spray etc.) provides its own unique set of properties and benefits, each of these processes also has limitations that should be addressed early on in the design process to ensure optimal performance
Pharmaceutical and Biotechnology companies are under a great deal of pressure to comply with regulatory requirements from the inception of a product to its final destination. One such aspect of the regulatory process is stability testing. Stability testing allows drug manufactures to expose the product to conditions that might occur in the supply chain, as well as provide for stress testing for determination of shelf life. Stability testing relies on three important parameters: 1) Control Constancy 2) Uniformity 3) Sensor accuracy Clay Hile of Parameter Generation and Control and Greg Gowaski of ROTRONIC discuss the important points of stability testing.
Most companies outsource prototyping because they have resource constraints. In some cases this is a strategic decision, but in many cases, it is simply the only way to meet the latest product development deadline. While many prototype houses can accommodate a “throw it over the transom” approach, taking a more strategic approach can save time, money and most importantly, help your team develop a higher quality product.
A Newson Gale White Paper, “You Don’t Have To Be a Rocket Scientist” is a concise engineering guide for the person responsible for protecting plant equipment and personnel from the hazards associated with the potential for static discharge. It provides a step-by-step audit procedure to evaluate the potential for a manufacturing or handling process to produce a static electric charge, how best to deal with it when flammable or combustible atmospheres also occur, and the content and scope of applicable engineering standards and guidelines.
The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors. The information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development.
The Vaisala CCL100 Cold Chain temperature logger might be simple and easy, but the regulations governing cold chain monitoring are complex. Read this new Application Note, "FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains" for help demystifying these regulations. This paper discusses a scientific approach to cold chain management, overview of ICH guidance, three key FDA regulations, and examples of cold chain 483 observations.
Engineers are continuously challenged to meet plant productivity and operating objectives as well as ensure regulatory compliance. FCI's White Paper, “Advancing Thermal Mass Flow Meters for 21st Century Process and Plant Needs”, explains a future-ready approach to air/gas flow measurement using breakthrough FCI's ST100 Series Flow Meters.
Accurately measuring moisture levels in an environmental chamber is both a surprisingly difficult and frustrating exercise. Many times the chamber’s instrumentation refuses to agree with handheld instrumentation. And there are instances when moisture generation inside the chamber gets so out of control, it can be literally “raining” inside. This white paper summarizes the various sensor designs, their typical problems, and some operational challenges of environmental chambers to be aware of.
Lighting Solutions for Lean Manufacturing: Increase Efficiency, Reduce Costs & Improve Quality
The biggest challenge for design teams is meeting tight timelines with smaller internal teams. This paper looks at ways to leverage readily available industry resources to reduce design, prototyping and debug time.