QP Certification for the EU and Rest of the World.

It’s almost seven years since the new revision of Annex 16 of the EU GMP Guide: Certification by a Qualified Person and Batch Release, came into effect on 15th April 2016. It was introduced due to the increased complexity of global supply chains as it was felt that the previous guidelines, relating to batches manufactured either partly or fully outside the EU/EEA had become open to interpretation.  The revision of Annex 16 in 2016 sought to address this..

Behind the Scenes: Exploring the Crucial Role of Importation Sites in Medicinal Supply Chains

October 23rd, 2023|Categories: Featured|

The Physical Site of Importation (SOI) plays a pivotal role in the pharmaceutical industry. It ensures Regulatory Compliance, upholding stringent EU/EEA standards.

Supplier Qualification Audit; so you have completed your pre-qualification assessment and you are wondering what the next step is?

By |July 24th, 2023|Categories: Featured|

The answer lies in a qualification audit. While a pre-qualification assessment can help identify surface deficiencies in the way a company operates, a qualification audit

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