A New Guide for Effective Customer-Supplier Partnerships

The ECA Good Practice Guide distills government guidance into a slim but comprehensive guide

Since the first "mother of all validation guidelines" in 1987, different methods for pharmaceutical equipment validation have come and gone, but the central goal of performing efficient qualification and validation activities remains. The European Compliance Academy (ECA) Good Practice Guide makes for an effective summary of how to perform qualification and verification in the modern (increasingly digital) landscape.

The ECA's guide was developed in part to respond to revisions to Annex 15 of the EU's Good Manufacturing Practices (GMP) guidelines which came into force in 2015. These revisions, along with the ASTM Guide 2500, were used in the development of a guide which promises to give pharmaceutical manufacturers a set of tools to use when developing their own qualification programs. Annex 15 is a critical part of the GMP guidelines as it includes sample documents and templates manufacturers can utilize in the development or refinement of their own equipment validation processes.

In addition to serving as an explanation of Annex 15, the ECA guide explains the way in which process validation integrates into the equipment qualification process. The integration of these concepts grew out of revisions to the FDA's Guidance on Process Validation, and result in an enhanced initial risk analysis covering both the technical qualification aspects and process validation aspect of a customer-supplier partnership. This streamlines the equipment purchasing process and provides support for equipment selection and integration.

The guidelines also discuss how to handle the increased digitization of equipment manuals, certifications and other documentation necessary for process auditing. In spite of the increased digitalization of important documents, many manufacturers still elect to keep printed copies on file, which makes keeping the documentation up to date even more important. On the reverse side of the coin, audits are also moving in an increasingly digital direction, meaning that manufacturers need to move to digitize their existing documentation. The ECA's guide provides insight on this topic too.

At 40 pages, the ECA guide presents its information both from the perspective of a pharmaceutical company and an equipment supplier, making it an invaluable tool for all involved in the equipment qualification and validation process. Using the guide, pharmaceutical manufacturers and equipment suppliers can easily come together to set expectations and ensure a strong partnership.

A deeper dive into the guide's contents can be found here https://www.gmp-journal.com/current-articles/details/final-version-ecas-good-practice-guide-integrated-qualification-and-validation.html