Featured Pharma Online Editorial

1. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

   Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

2. Using Relational Risk Analysis To Control Procedure Failures 2/15/2024

   In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).

3. Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity 2/8/2024

   It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.

4. Need To Improve Your Change Management? Regulators Can Help With That 1/12/2024

   The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.

5. Your 6 Priority Areas For A Successful 2024 11/27/2023

   As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.

6. Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems 11/16/2023

   With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.

7. 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.

8. 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.

9. 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.

10. 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.