News

Cleaning Validation from the FDA's Point of View

The requirements for cleaning validation are not very clearly defined in the US GMP regulations 21 CFR 210/211. Even a Guide to Inspection on this topic dating back to the 1990s does not represent the FDA's current interpretation. Current Warning Letters on the subject of cleaning validation are helpful here.

More
ECA Foundation's Validation Interest Group announces Change in its Leadership

The ECA Foundation Validation Group's goal is to initiate and facilitate active discussions of current and new regulatory requirements regarding Process Validation and Equipment Qualification. Now the group announced a change in its leadership team.

More
Results Survey Remote Factory Acceptance Tests (Remote FATs)

Due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So “remote-FATs” came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up. Find out what the survey results were.

More
FDA´s former Senior Policy Officer Grace McNally speak at ECA´s Launch Conference

At ECA´s Online Launch Conference on 16/17 November 2021 an EU Inspector and FDA´s former Senior Policy Officer, Grace McNally, will share their views on ECA´s Good Practice Guide Integrated Qualification and Validation in the new version 2.0. Grace McNally chaired the workgoup, which has developed FDA´s General Principles and Process Validation Guidance.

More
Aide-Memoire from the PIC/S regarding the Inspection of Quality Risk Management

The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation.

More
Ongoing/Continued Process Verification with SPC

The author of the article "Practical SPC Rules in the Real World of an Ongoing Process Verification Plan" in the October 2021 issue of the Pharmaceutical Technololgy Journal lectures about this topic at ECA online course.

More
Current FDA Requirements for Cleaning Validation

Since the GMP regulations are sometimes not very specific, concrete regulatory guidance on implementation is very helpful. In a current Warning Letter, the FDA specifies their requirements for cleaning validation. What does the FDA require?

More
What is the FDA's Position on Concurrent Validation?

In the FDA Guidance for Industry on process validation, there is also a short section on concurrent validation. Concurrent validation should be used rarely, but may be possible if, for example, products are manufactured infrequently or medically necessary products are needed for short-term market supply. A recent Warning Letter underlines the guideline's statement that concurrent validation should be used rarely.

More
ICH Q9 Risk Management to be Revised

Since 2005, the ICH Guideline Q9 has been the state of the art when it comes to quality risk management (QRM) in the GMP environment. Now it is to be revised. What is planned?

More
The Influence of Process Changes on Process Validation

What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.

More
x
Search