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..

UK Requirements for a RP to be on a Wholesale Distribution Authorisation (WDA)

September 27th, 2023|Categories: Featured|

The Responsible Person (RP) on a UK Wholesale Distribution Authorisation (WDA) for pharmaceuticals has specific responsibilities to ensure that imported pharmaceutical products

ATMPs and why you should use MIAS Pharma as your Batch Certification partner of choice

August 30th, 2023|Categories: Featured|

Advanced therapy medicinal products ( (ATMPs) are medicines that are based on genes, tissues or cells which offer groundbreaking new opportunities for the

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

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners

By |July 5th, 2023|Categories: General News|

New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, the

Disposition of Medicinal Product to the UK market following EU QP Release

By |June 27th, 2023|Categories: Featured, Technical Article|

The Qualified Person (QP) Role is well established for certification of medicinal products in the European Union (EU) and European Economic Area (EEA). It

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