Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
EPR’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry.
In this Q&A, Recipharm’s Torkel Gren discusses developments in capsule formulation, including the shift away from gelatine and the potential for growth in the inhalation capsule market.
In the first clinical trial of its kind, faecal microbiota transplants (FMT) were shown to improve immunotherapy response in advanced melanoma.
The PAT-based approach is the first of its kind to prevent membrane fouling when using a robust single-pass tangential flow filtration (SP-TFF) operation in bioprocessing, according to a paper.
Solutions for technology and government policy to address current challenges and drive economic growth in biopharma and Medtech have been recommended in new reports.
UK researchers have developed two of the world’s most common painkillers from a pine-derived compound, meaning new sustainable turpentine-based pharmaceuticals could be on their way.
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
According to a report, growing demand for cost-effective and efficient drug development processes is propelling the global clinical research organisation (CRO) market.
Parenteral Drug Association (PDA)'s 2023 technical report on nonconformities in glass containers during pharmaceutical manufacturing represents best practices for identification and classification.
For the first time, a medicine to treat the most common form of cystic fibrosis has been approved in paediatric patients aged one to under two years old.
Welcome to EPR's Guide to Data Integrity. In this edition, Charles River explores the significance of data integrity in pharmaceutical manufacturing, Graeme Bones of ICON considers how to complete database transfer with data integrity considerations at the forefront and Rapid Micro Biosystems® discusses the practical implications of the ‘four-eyes principle’ for pharma…
"Development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm” in moderate-to-severe plaque psoriasis (PsO), stated a Janssen R&D VP.
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
This in-depth focus features articles on trends in capsule formulation and the evolving role of titanium dioxide in formulation.