Search results for " documentation"
Article
CoAs Help Secure the Supply Chain
European Commission, EudraLex Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part I, Basic Requirements for Medicinal Products, Chapter 4: Documentation (EC, 2…
Article
Supplier-Change Management for Drug-Product Manufacturers
…rformance of a material used in manufacturing or testing, or which will impact manufacturing-related documentation. These changes need to be known prior to implementation so that manufacturers can fu…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Challenges on numerous fronts
Challenges to rapid changeover come from many sources, including the equipment, room configuration, documentation, people, and environmental monitoring, according t…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
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
Regulatory Challenges in the QbD Paradigm
REGULATORY IMPLICATIONS OF QBD
QbD cannot exist without an effective quality system that oversees and manages process variability and product quality through appropriate control strategies, docume…
Article
The Importance of Partnering for Bioanalytical Studies
This requires companies having a quality system in place, regular audit of the facility, maintaining documentation, training records, instrument qualification, and so on, all of which often becomes to…
Article
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
…
Article
Understanding Validation and Technical Transfer, Part 3
No matter what type of product, the stage of development or manufacture, or the form the validation studies take, if there is documentation supporting answers to all of the questions about a process t…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
Roadmap Leads to Innovative Biomanufacturing Strategies
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
By Feli…