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..
Behind the Scenes: Exploring the Crucial Role of Importation Sites in Medicinal Supply Chains
The Physical Site of Importation (SOI) plays a pivotal role in the pharmaceutical industry. It ensures Regulatory Compliance, upholding stringent EU/EEA standards.
Function of the RP (Responsible Person)
The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good Distribution Practice (GDP) guidelines,
The Role of GDP in preventing falsified Medicines
The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good Distribution Practice (GDP) plays
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 types of products on offer have
Function of the RP (Responsible Person)
The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good
The Role of GDP in preventing falsified Medicines
The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good
UK Requirements for a RP to be on a Wholesale Distribution Authorisation (WDA)
The Responsible Person (RP) on a UK Wholesale Distribution Authorisation (WDA) for pharmaceuticals has specific responsibilities to ensure
When is it ok to do a remote Pharmaceutical Audit vs an on-site Audit?
The decision to conduct a remote pharmaceutical audit or an on-site audit depends on various factors and should be made based on a risk-based approach,
What indicators would you look for to set Pharmaceutical Audit frequency?
Setting the pharmaceutical audit frequency involves considering various indicators and factors to ensure that the auditing process is effective and risk-based. The goal is to
Supplier Qualification Audit; so you have completed your pre-qualification assessment and you are wondering what the next step is?
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