FEATURED TECHNICAL ARTICLE
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.
QP Certification for the EU and Rest of the World
How times flies! It’s almost seven years since the new revision of Annex 16 of the EU GMP Guide: Certification by a
UK retains acceptance of batch testing and EU certification
Last year, the UK Department of Health & Social Care issued a statement emphasizing their continued support for the acceptance of batch
QP Audits to ensure GxP Standards
Introduction For any organisation that plays a role in the supply of pharmaceutical products such as manufacturing, QC testing, packaging, storage and
WDA and its importance
A wholesaler distribution license is a permit issued by regulatory agencies that allows a company or individual to distribute pharmaceutical products, medical devices, or
What is an RP (Responsible Person) in pharmaceutical industry?
An RP, or Responsible Person, is an individual who holds a key role within a pharmaceutical company that
Importance of matching the correct QP to your product
Introduction: MIA for Marketed Products: Importance of matching the correct QP to your product As science advances the
MIAS Pharma TO ATTEND BIO-EUROPE SPRING® 2023
MIAS will attend BIO Europe spring 2023 MIAS Pharma will be attending 17th annual BIO-Europe Spring
QP declaration for Investigational Medicinal Products
When submitting a trial application for a clinical trial in the EU/EEA using an Investigational Medicinal Product (IMP) manufactured in a 3rd country (a
Sponsor Responsibilities: IMP Shipping & Handling
In accordance with the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs for human use in accordance with
What should be taken into consideration when assessing suppliers?
Wholesalers must ensure that their suppliers are permitted to supply pharmaceuticals. Legal History The following is applicable in accordance with chapter 5.2 of the EU