Downloads
-
Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
8/29/2022
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
-
How To Avoid Form 483s For Biopharma Software Validation Failures
8/17/2022
The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.
-
Impurity Control Strategies For Therapeutic Peptides
8/12/2022
Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate from raw materials, manufacturing processes, degradation, and other causes. This article shares perspectives and recommendations discussed at USP's recent 2022 workshop on the topic.
-
FDA Seeks Comment On Conducting Remote Regulatory Assessments
8/11/2022
The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.
-
Tools & Techniques For Biopharma Root Cause Analysis
8/10/2022
In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.
-
Data: The Near Future Of Regulatory Info Management In Europe
7/29/2022
Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.
-
TSI Life Sciences Brochure
7/19/2022
Pharmaceutical companies, medical device manufacturers, biotech companies, healthcare facilities and other regulated organizations are subject to a variety of laws and regulations regarding the production, storage and testing of their products.
-
The Booming Merger Of Biopharma Separation Techniques & Mass Spectrometry
7/6/2022
The evolution of modern mass spectrometry (MS) as well the hyphenation of MS to a broad range of analytical separation techniques used in biopharma development has fueled a strong development in analytical tools for physicochemical characterization.
-
Solving Bioassay Challenges For Cell And Gene Therapies
7/1/2022
A recap of USP's bioassay training workshop that included regulatory considerations, analytical validation, and case studies related to bioassays for cell and gene therapy products.
-
Mold Investigations Using Biofluorescent Particle Counting Systems
6/27/2022
In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime.