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.
Pharmaceutical companies are moving away from all-inclusive, in-house operations and partnering with Contract Development and Manufacturing Organizations (CDMOs) for solvent-based solid-dose manufacturing. When researching CDMOs, important considerations about the organization’s capabilities and processes should be assessed. Although the considerations reviewed in this white paper are not intended to replace the quality assurance standards that companies have in place, they provide a guide to increase the confidence you have in your manufacturing partner.
When moving into the commercialization phase, many basic business applications tend to quickly reach their limitations. Forward thinking manufacturers address these key business processes and requirements early on, in order to minimize growing pains while keeping up with exponential increases in production and federal regulations.
Considering replacing your existing ERP application or upgrading from spreadsheets? By understanding the key functions and architecture of a process-oriented, formula based ERP application, you will have a better foundation for choosing a solution that best suits your company and type of manufacturing.
In this collection four experts discuss several ways to reduce the risks of failed inspections, bad measurement practices, and poor product quality in controlled environments. Topics span from measurement accuracy, uncertainty, stability, and traceability, to a discussion of wired v. wireless connectivity for sensing instruments, to FDA inspection preparation and 483 responses. These articles offer a surfeit of tweaks, tips, and tricks for developing better quality management systems for GxP-compliant environmental monitoring applications.