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.
Tubing used in pharmaceutical and biotech applications has particular requirements. Among them are the ability to withstand sterilization processes, the delivery of favorable test results regarding extractable substances, and the absence of animal-derived ingredients. These industries also have tubing needs involving flexibility, performance, and cost that are common to many applications.This white paper offers ten suggestions on what to look for and investigate when it comes to narrowing down your single use tubing selection.
GMP regulators in the United States, Canada, European Union, Japan, Australia, and China have sharpened their focus on warehouse storage and distribution practices and require “mapping” the temperature and relative humidity profile of warehouses for environmentally sensitive life science products. This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs—including many that have been published or revised recently. It draws on Vaisala’s extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries.
Testing for moisture in lyophilized materials has well documented benefits to ensuring quality and shelf life. It has been previously demonstrated that the Computrac® Vapor Pro® Rx is a perfect fit for testing for moisture in lyophilized samples. The samples can be tested in the lyophilization vials without ever being exposed to ambient air. The relative humidity sensor in the instrument is sensitive enough to allow for sample sizes as small as 5 mg.
About a decade ago, the debate about Single-Use Systems (SUS) vs. traditional stainless-steel was just a whisper: reusable steel was favored because it was the system that process designers and users had relied on for years. Then awareness of the cost savings and environmental benefits of SUS grew, and a shake up in the industry started.
Precise process control strategies have accelerated the use of on-line chemical composition analyzers in plant applications. Contaminants in plant samples are the most frequent cause of problems with on-line analyzers. Trace contaminants can rapidly build up and cause instrument failure - DOWNLOAD WHITE PAPER.