How to save Time and Money in International Equipment Qualification Projects?
The regulations with regard to Qualification and Validation are different in the US, in Europe in China and other countries. But, the core thinking is similar, though.
What these activities have in common is that they cost a lot of time and money. In many companies, pharmaceutical projects entail internal requirements - including numerous activities and documents. However, many of these are unnecessary - and possibly delay projects.
What's more, with the increasing globalisation equipment qualification also becomes global. Equipment, for instance, is purchased from suppliers around the world. However, sometimes they don't know the local or the specific customer requirements. And these customer requirements are very different, although the regulations are similar or even the same. Some of the big questions to be answered are:
What regulations are expected to fulfill (national vs international)?
Do all parties have the same "GMP philosophy", (e.g. what does qualification mean?, what are the differences between qualification and Good Engineering Practice (GEP)?), etc.?
ECA´s version 1.0 Good Practice Guide Integrated Qualification and Validation focuses on how to work with suppliers in cost-effective projects. This ECA Good Practice Guide was developed by a team of pharma, supplier and engineering companies and launched in autumn 2020.
Many companies "qualify everything" to satisfy regulators, and qualification tests are repeated again and again during the qualification tests. The partners working together on ECA´s Good Practice Guide therefore shared templates, examples and best practices for many typical project documents: User Requirements Specifications (URS), Requirement Traceability Matrix (RTM), Design Qualification (DQ), Test Matrix (TM), Critical Aspects Risk Assessment (CARA) and others. These templates are useful tools for a science- and riskbased approach to qualification and validation.
12/13 October 2021
Advanced Level Live Online Training: Trending of Process Data for OPV/CPV
In summary this means: In the global world of pharmaceuticals, global standards are needed to meet local requirements. The Integrated Qualification and Validation Guide thus is a guide to effective qualification based on a customer-supplier partnership, providing hands-on templates to help customers and suppliers work together towards a "lean qualification" in an integrated way. It explains also the connection between qualification and validation as it is also described in FDA´s Process Validation Guidance.
How to use this Good Practice Guide in daily qualification activities? How is the influence of qualification into process validation?
Heidelberg, Germany26/27 January 2022
Process Understanding - Statistical Process Control (SPC) as a tool to get there
These questions will be explained in an one-day online course: Effective Equipment Qualification according to Annex 15 - by cooperation between pharmaceutical companies and suppliers on 8 June 2021 9.00 - 17.15 h. The online course covers:
- ECA´s GPG Integrated Qualification and Validation
- How suppliers work: Good Engineering Practice in Qualification,
- Cooperation between customers and suppliers on Integrated Qualification and Validation
- ECA Q&V Guide and tools: Risk-based qualification from from URS to PQ
- ECA Q&V Case Study: Fast and effective project execution with suppliers
Of course, all participants will receive the Good Practice Guide with the templates, project documents etc.
... is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy in the area validation.