Search results for " ISO"
Article
Evaluating Design Margin, Edge of Failure and Process
The ISO definition is “Process Capability: Ability of a process to produce a product that will fulfill the requirements of that product. The concept of process capability can also be defined in statis…
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Using Quality by Design to Develop Robust Chromatographic Methods
ISO, ISO 21748:2010, Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation (Geneva, 2010).
10. ISO, ISO/IEC 17025:2005, General requir…
Article
Modular Manufacturing Platforms for Biologics
… have a cleanliness class assigned to the space and are not monitored like grade-classified rooms or ISO areas (4). Although the goal of a cleanliness classification through a Federal Standard 209 is…
Article
Gowning Practices Provide Clues to cGMP Compliance
For centralization, functions of the same cleanliness grade must be grouped together and not dispersed into individualized or isolated islands of production. Centralized gowning is also indicative of …
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
ISO, ISO 16269-6:2014, Statistical Interpretation of Data, Part 6 - Determination of Statistical Tolerance Intervals (Geneva, Switzerland, Jan. 23, 2014).
12. PDA, Technical Report 59: Utilization…
Article
Robust Business Continuity Program Helps to Maintain Operations in the Face of Crisis
As we began 2020, no one could have foreseen that just a few weeks into the year, we would be facing a pandemic threatening unprecedented damage to human health and the world economy. Businesses are…
Article
Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
Article
Securing the Single-Use Supply Chain
“Cytiva sought to satisfy the industry’s need to mitigate this risk through a strong focus on business continuity planning (in accordance with ISO 22301 and achieving conformance to this standard), in…
Article
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…