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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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Understanding cGMPs for Phase 1 Investigational Drugs

By Dan Carpentio, July 18, 2019

Everyone in the pharmaceutical manufacturing industry understands or has at least heard of current Good Manufacturing Practices (cGMP).  The requirements of the cGMPs are prescribed in Title 21 of the Code of Federal Regulations parts 210 and 211 (better known as 21 CFR part 210 and 211).  But there is a unique situation in which the requirements of 21 CFR 211 in the manufacture of a drug are exempt.  That is for the manufacture of Phase 1 investigational drugs.

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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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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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Implementing USP Visual Inspection Requirements

By Eamonn Vize, November 21, 2017

The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified. 

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GEP In Projects – To Practice, Or Not To Practice?

By Bob Perry, October 17, 2017

As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following good engineering practice (GEP).  While GEP is an expectation in the life sciences industries, the basic GEP elements required as a basis for GxP (good “anything” practice) quality guidelines and regulations compliance can, and should be, applied to all projects.

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Are You Ready? Major Changes Coming to Europe MDR and IVDR

By John Henchion, September 28, 2017

Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.

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