India to hold pharma companies responsible for drug quality after reforms
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
List view / Grid view
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimise costs. Here, Peter DeYoung shares his thoughts on the key trends he expects to see in the contract…
Enhancing the production of pharmaceutical tablets is extremely important in modern manufacturing processes and companies will go to great lengths to ensure production runs efficiently in order to stay competitive. As time and capital implications become drivers within the production of solid dosage forms, investigation into improving production methods is…
Glidants and lubricants are important additives in the production of solid dosage formulations. This article compares the results of various methods to characterise the flowability of blends, demonstrating the importance of considering the impacts that glidants may have, not only on the flowability of blends, but the physical attributes of…
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
Any envisioning of ‘the future’ of testing contains elements extrapolated from the past.
19 February 2020 | By SUEZ
Watch our on-demand webinar which will guide you through efficiency gains with TOC for cleaning validation. We call it a ‘beginner’s guide’, but this webinar will benefit long-time TOC users as well as those new to using TOC for cleaning validation.
Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
European Pharmaceutical Review explores how plants can be used for large-scale, glycosylated protein bioproduction for the pharma industry.
Dr Finn Bauer discusses how Merck KGaA and its SAFC® portfolio brand is addressing drug formulator challenges.
In the light of recent media coverage about product recalls – particularly resulting from the detection and presence of NDMA – this article outlines ways to avoid the wide-ranging negative impacts on patients, pharmacies, manufacturers, pharmaceutical companies and health authorities and offers ways to mitigate the risk of future recalls.
In this in-depth focus are articles discussing how to optimise production by using the correct tablet tooling and why logistics can be affected by developments in the pharmaceutical industry.
Scientists have divised a way to manufacture protein drugs using lettuce leaves, which has presented a potential drug for pulmonary arterial hypertension.
A facility has opened in Ireland which will allow the biopharma industry to trial and simulate the latest bioprocessing and quality control technologies in a GMP environment.
Within this issue are articles which investigate polyelectrolyte multilayers as drug carriers, discuss how developments in pharma impact logistics and examine how the industry can regulate heavy metals in medicinal cannabis. Other features include how to use the correct tablet tooling and trends for the CDMO sector this year.