Mean Kinetic Temperature in GxP Environments
The history of the mean kinetic temperature calculation in pharmaceutical manufacturing and distribution. Also the regulatory guidance that describes where and when to use the...
Tagged: Vaisala
Understanding Test Accuracy Ratio,Test Uncertainty Ratio and the Practical Application of Total Uncertainty
A while back our application engineers received a question on uncertainty in probes used in stability chambers. Here we offer two good references and help...
50+ FDA Acronyms That Matter to Your Business
While not focused on cold chain, this resource from Vaisala defines 50+ FDA relevant acronyms grouped in 7 different topical sections, and also provides a...
VIDEO: Modern Rules for an Old Practice: Sensor Placement for GxP Environments
A 1-hour training in five best practices for performing temperature mapping studies The regulatory environment regarding controlled temperature storage of life science products is changing quickly....
AstraZeneca Increases Efficiency with Continuous Monitoring System in Leading Manufacturing Facility
To ensure the products are protected during manufacturing, packaging, and storage, AstraZeneca maintains strict controls over environmental parameters. The company adheres to cGMP (Current Good...
FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains
The following are the topics covered in this White Paper from Vaisala: A Scientific Approach to Cold Chain Management An overview of ICH Guidance 3...
Connecting the Dots: PIC/S, ICH and FDA regulations in Environmental Monitoring
The Vaisala team received the following question: “Is there any description of continuous monitoring systems for Quality Control labs and warehouses in FDA regulations? Can...
Worst case scenario simulation in validation/qualification of transport containers
Having said that, along with providing monitoring and validation systems, we enjoy delving a little deeper into some of the issues that come up in the validation applications of...
Using the ISPE’s GAMP Methodology to Validate Environmental Monitoring System Software
Continuous Monitoring Systems (CMS) are used in the pharmaceutical industry to detect out-of-speci cation (OOS) conditions in manufacturing, processing and distribution environments. These modern, Web-based...
Meeting Regulatory Requirements for Periodic Remapping… Where is the wiggle room?
This blog post from Vaisala discusses the following questions: When determining hot/cold spots, do you look at average or single temperature peaks? Do you assign a location as a...
