blog hero 7-1.png

Blog

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

Read More

Quick Glance: ICH Q10 Question Solved?

By John Henchion, February 13, 2020

Read More

Quick Glance: Regulatory and Inspection Harmonization

By John Henchion, February 6, 2020

Read More

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.

Read More

FDA Approves Emergency IND in Less Than Three Hours

By Cheryl Bondurant, June 27, 2019

How a CAI agent helped make a difference

Read More

How to Measure PQS Effectiveness Using the CAPA System

By John Henchion, June 25, 2019

A ICH Q10 Challenge

 

Read More

Visit us at Table 9 at PDA EU Annual Meeting

By John Henchion, June 22, 2018

 

Read More

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

Read More

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. 

Read More
How to Understand ASTM E2500