Search results for " change notification"
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
Article
Supplier-Change Management for Drug-Product Manufacturers
This article provides an overview of the pharmaceutical SIC process, including a discussion on the need for control of SICs, a review of change notification scope and content, and a summary of how SIC…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Securing the Single-Use Supply Chain
Many of the industry-wide initiatives already underway to provide standardization and guidance on change notification, leachable/extractable testing, and other end-user needs for increased adoption of…
Article
Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
Article
The New World of Biopharmaceutical Manufacturing
…product lifecycle management aspects (from user requirement specifications to management of supplier change notifications post-implementation). The establishment of industry standards such as ASTM E3…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
…
Article
Advancing Single-Use Technology Through Collaboration
Efforts toward standardizing the supplier change control and change notification processes, as well as standardizing user requirements, have also been initiated as joint efforts between end users with…