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Quick Glance: Take an Extra 5 Minutes for Safety and Quality

By Brian Nieport, March 26, 2020

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UPDATE: Second Stakeholders' Consultation on the Revision of Annex 1

By John Henchion, February 21, 2020

The second targeted stakeholders' consultation on the revision of Annex 1, on the manufacturing of sterile medicinal products, of Eudralex Volume 4

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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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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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Release of 2nd Edition ISPE Baseline Guide 5 for C&Q

By Steve Wisniewski, July 16, 2019

Intro

ISPE has just released the second edition of Baseline Guide 5 for Commissioning and Qualification (C&Q) The objective of the 2019 C&Q Baseline Guide revision is to define and explain a simplified risk-based C&Q process in a single guide that meets present-day standards and provide focus to ensure a compliant, efficient, and cost-effective approach.  The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment.  It supersedes the 2001 publication and the two 2011 Guides covering Quality Risk Management/ASTM E2500 based approaches.

The new Guide provides an improved QRM C&Q process flow and recommended implementation practices with practical examples taken from the industry.

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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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How to Understand ASTM E2500