Guest Columns
-
Understanding The Importance Of Real-Time Monitoring For Protein Aggregation
10/30/2023
This article breaks down the advantages of real-time monitoring for protein therapeutics, including how it can accelerate timelines, produce better data, and smooth regulatory compliance.
-
Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2
10/27/2023
This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.
-
The 6 Types of Bio/Pharmaceutical Consultants
10/26/2023
In today’s consulting marketplace, there are numerous firms and individuals who consider themselves “consultants,” but, in fact, there are different types of consulting services. Determining which will serve you best is an important decision before you seek support.
-
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.
-
FDA Warning Letters Dipped, But Don’t Get Cozy
10/19/2023
Between October last year and March this year, FDA inspectors showed a heightened level of discretion for OAI inspections, choosing to withhold enforcement action. This isn't an invitation to breathe easy; there's a reasonable explanation for less enforcement action.
-
Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses
10/18/2023
Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.
-
Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations
10/12/2023
Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.
-
Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1
10/6/2023
All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.
-
Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations?
10/6/2023
Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.
-
Here’s Why Outsourcing To CDMOs Doubled In 13 Years
10/4/2023
It might surprise no one that BioPlan Associates' 20th annual survey on manufacturing found an increased dependence on contract manufacturing. The sheer rate at which demand has grown, however, is stunning, and the survey found CDMO capacity is only now starting to catch up with supply.