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Blog

Achieving Capital Project Success Through Organizational Maturity

By John Hughes, April 16, 2020

Every organization has some “big problem” that they need to address. New software, sensors, equipment, or analytics can sometimes be the solution to that problem. But sometimes there is a nagging thought that the real issue is more institutional than asset-based. Almost universally, companies that successfully leap into the Internet of Things (IoT) are already mature, efficient, and agile. They don’t need to solve nagging performance issues. They aren’t looking at software as a solution or performing maintenance by capital project. They’re making a step change to maximize already satisfactory performance metrics.

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Quick Glance: ICH Q10 Question Solved?

By John Henchion, February 13, 2020

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Quick Glance: Regulatory and Inspection Harmonization

By John Henchion, February 6, 2020

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EU & US MRA Fully Operational - What You Need to Know!

By John Henchion, July 25, 2019

Background

In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.

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FDA Approves Emergency IND in Less Than Three Hours

By Cheryl Bondurant, June 27, 2019

How a CAI agent helped make a difference

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How to Measure PQS Effectiveness Using the CAPA System

By John Henchion, June 25, 2019

A ICH Q10 Challenge

 

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5 Factors in Choosing a Partner Firm to Accelerate Speed to Market

By David Shenberger, January 24, 2019

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they get a drug into trials, and eventually to the marketplace, as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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Visit us at Table 9 at PDA EU Annual Meeting

By John Henchion, June 22, 2018

 

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E-Pub: The Importance of Annex 1

By John Henchion, May 21, 2018

Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this revision will have impact way beyond the EU borders.

World Health Organisation (WHO-all United Nations are members) and Pharmaceutical Inspection Co-operation Scheme (PICs) are actively involved in the update of Annex 1. The guidance is being developed with global harmonization of standards in mind.

Click below to view the full brochure on our understanding and capabilities surrounding the changes to come with this update:

Click Here to Read our E-Pub on our Understanding of Annex 1

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Moving the Goalposts?

By John Henchion, April 5, 2018

Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?

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How to Understand ASTM E2500