Newsletter | January 11, 2025

01.11.25 -- Pharmaceutical Online Best Of December

DECEMBER'S BEST FEATURED EDITORIAL

Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies

The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

Count On Data Integrity Auditors Making These 10 Requests

Every audit, however unique, requires confirmation that effective data integrity governance exists, supported by strong SOPs, proper validation, and regulatory adherence.

Are We Witnessing A New "Age Of The CDMO"?

In recent years, the industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective on what to expect in 2025 and beyond.

DECEMBER'S BEST INDUSTRY INSIGHTS

What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?

The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the industry to strategize to achieve the best compliance method.

Best Practices In The Design Of A Pharmaceutical Manufacturing Facility

A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.

Step-By-Step Guide To Tech Transfer Preparation And Execution

How does a sponsor accurately transfer detailed knowledge about its product composition, development, and current manufacturing processes to its CDMO?

DECEMBER'S BEST SOLUTIONS

A Digital Solution For Validation Management

Capacity Update October 2024: Small Molecule

A Standardized Gloveless Robotic Isolator

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