Validation, Commissioning & Design Featured Articles
-
Nitrosamine Impurities Deadline: Are Your Products Compliant?
11/6/2023
The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.
-
Human Performance Theories And SOPs: Human Error Prevention In Manufacturing
11/3/2023
Standard operating procedures (SOPs) are often viewed as mere documents to be followed, rather than as dynamic tools. Drawing on human performance theories, this article explores how to create, review, and train on SOPs, as well as how manufacturing and quality teams can collaborate to improve oversight, all with human error prevention in mind.
-
FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance
11/2/2023
As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.
-
Three Ways Manufacturing Excellence Drives Value For Life Sciences
11/1/2023
Check out three ways Honeywell’s Manufacturing Excellence Platform delivers value in terms of costs, revenue, and risk.
-
Digitalizing Biopharma Manufacturing Step-By-Step: Part II
11/1/2023
Explore a modular approach to digitalization involving the development of electronic logbooks and procedural guides, weigh and dispense processes, and Master Batch Records/Electronic Batch Records.
-
Digitalizing Biopharma Manufacturing Step-By-Step: Part I
11/1/2023
Digital transformation offers tangible advantages in terms of time, cost, and efficiency. Learn about a popular way to digitalize high-risk environments that can be achieved easily in biopharma manufacturing.
-
How Automation Can Help Fast Track Vaccines
11/1/2023
The urgency of the coronavirus pandemic has demonstrated the need for expedited vaccine development. Discover how digital tools can help speed up the vaccine manufacturing process.
-
Remote Work Success Is Built On Pre-Site And Site Initiation Visits
10/31/2023
The unique demands of remote work can require institutions to fundamentally change their organizational structure to empower the use of remote work tools and strategies.
-
FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
10/25/2023
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
-
The Future Of Automation For Container Closure Integrity Testing
10/19/2023
New regulatory guidance documents continue to tighten the narrative on what is expected of container closure integrity.