Download this new Application Note: "Matching Environmental Monitoring & Mapping to FDA/ICH Guidance for Better Stability Studies" and learn how to minimize the risk of data gaps. If your data is incomplete as a result of infrastructure failures during environmental mapping or monitoring applications, your testing may not comply with FDA/ICH guidelines. Learn how redundant monitoring devices reduce the risk of incomplete records. Get this PDF…
This peer-reviewed paper (published in the Journal of Validation Technology) focuses on two sensors used in thermal mapping: thermocouples and thermistors, and describes advantages and disadvantages of both, concluding that thermistor-equipped data loggers can be used in regulated environments.
Learn how to evaluate your environmental monitoring applications to find the ideal connectivity to your network. There are times that wireless is a panacea, and times when a hybridized “wired-plus-wireless” system is a better solution. Read more…
In the ever competitive marketplace companies need to take advantage of the technologies that are available to them. Replacing dated technologies like the paper chart recorder with better more advanced technologies seems like a logical choice but many companies have been reluctant to change or simply not be aware of the cost savings involved. By using a modern humidity and temperature data logger users have the advantage of better accuracy, more functionality, less maintenance and an overall cost savings.
This free white paper, 5 Must Have Strategies for Enterprise Quality, shows how quality can take a more prominent, enterprise-scale role.
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.
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:
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 new Airchip3000 technology from ROTRONIC reduces humidity and temperature calibration time and cost. Learn how ROTRONIC has eliminated one full step from the calibration process, thus eliminating the cost of the additional calibration cycle.
This article features several excerpts from Form 483s involving environmental. Observations range from failure to properly validate containers to a lack of temperature records in an aseptic processing area.
Ajinomoto's Corynex™; Recombinant Protein Expression System is a novel protein expression system able to produce complex proteins using a specially-developed gram-positive bacterium, Corynebacterium glutamicum.
The Executive Guide to Contract and Chargeback Management: How Pharmaceutical Manufacturers Smartly Automate to Strengthen ProfitabilityAugust 24, 2011 11:54 am
Small and mid-sized pharmaceutical manufacturers are struggling to manage large group purchase organization (GPO) contracts, process heavy volumes of chargeback submissions and ensure pricing policies are fully compliant with regulatory requirements
As more pharmaceutical, bio-sciences and R&D-centric firms move to electronic lab environments, your digital scientific research, formulas and clinical findings are your Intellectual Property.
This white paper identifies many of the challenges faced by environment administrators on a daily basis and how a wireless environmental monitoring system can help to maintain data integrity and meet all compliance requirements.
Protecting & Legally Defending the Authenticity and Ownership of Your Scientific Intellectual Property for the Long TermJanuary 28, 2011 6:59 am
As a pharmaceutical or bio-sciences firm, your research, formulas and clinical findings are the "lifeblood" of your business. But if you aren’t protecting the integrity of your scientific research data in your lab management workflows, you risk losing patent ownership, revenue and consequently your business if you can't prove time of creation (“first-to-invent”) and authenticity.
With more than 50 percent of Form 483 observations and warning letters citing Corrective Action/Preventative Action (CAPA) deficiencies, today’s manufacturers must begin to shift their focus and address current processes, practices and systems