Validation, Commissioning & Design Featured Articles
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Streamline Early-Stage Development To Reach The Clinic Faster
7/17/2023
Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.
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Avoid These 29 API Manufacturing Deficiencies
7/17/2023
Most API manufacturers are constantly improving their processes, but mistakes still happen. This list of deficiencies from the GMP Compliance Adviser explains what to watch out for.
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Combination Product QMS Requirements For The EU Market
6/30/2023
Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.
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ICH Q12 Post-Approval Change Management Protocol
6/27/2023
The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.
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Annex 1 Compliance Guidelines For Biological Indicator Users
6/26/2023
Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.
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5 Ways Pharmaceutical Manufacturers Can Improve Productivity And Quality
6/22/2023
With expectations that drugs will be produced faster and more inexpensively, how can a pharmaceutical manufacturer be prepared for what’s on the horizon?
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Slide Down The Funnel To Stand Out
6/21/2023
Explore the tremendous value of understanding brand position in the biopharmaceutical market and how research into strategic placement, target audience, and more can help companies stand out.
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An Agile Approach To Regulatory Information Management System Transformation
6/20/2023
Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically.
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Lost CMC Data In An ALCOA+ World
6/19/2023
As technologies advance, the drug/therapy products we make are becoming more complex, and so are their data fingerprints. This article takes a hard look at the way we currently capture and manage chemistry, manufacturing, and controls (CMC) development and manufacturing operations data, and sheds light on how the document-centric mindset of ALCOA+ is not suitable to support the transition to digital CMC and FAIR data management.
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The 3 Stages Of MES Analytics For Drug Manufacturing
6/14/2023
In order to access all of your organizations manufacturing data and insights, the most practical solution is a cost effective, modern MES for all lines and stages.