spacer
home > pmps > spring 2017 > manufacturing a renaissance
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Manufacturing a Renaissance

The pharmaceutical industry is proud of its technical innovations in the discovery and development of new medicines, and rightly so – for example, the discovery of penicillin and its development as a drug product revolutionised the treatment of infectious diseases. But the pharma industry has sadly fallen far behind in product manufacturing efficiency and innovation. The polymer and foods sectors especially are constantly driving continuous improvement in manufacturing efficiencies, whereas pharma manufacturing practices have not changed significantly in fifty years.

This inertia has been attributed to constraints by regulatory agencies in what are deemed acceptable manufacturing and quality control practices. Batch processing continues to be the normal practice for medicinal products, due to the visibility and control over quality critical factors such as ingredient lots used and processing parameters. However, things are changing.

Implementation of Quality by Design (QbD) principles in product development is resulting in greater emphasis being placed on demonstrating process control through the monitoring of critical process parameters to confirm satisfactory product quality, instead of relying on the traditional approach of the testing of stratified samples. This approach is now considered as ‘best practice’ by regulatory agencies.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

spacer
Robert Harris
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

ERT Enables Clinical Trial Continuity through At-Home Respiratory Solutions

April 1, 2020 – ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, today announced multiple options that enable trained healthcare professionals to advance respiratory clinical trials by collecting high-quality spirometry data during patient home visits. ERT’s At-Home Respiratory Solutions enable clinical trial sponsors to continue developing new respiratory treatments while patient access to investigative sites is limited due to COVID19 stay-at-home mandates.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

 
Industry Events

Formulation and Drug Delivery Series UK

8-9 July 2020, Oxford Global

This event brings together leading formulation, drug delivery and biologics manufacturing experts from around the world across two days. The panel of prominent industry leaders and world-leading scientists will share the latest case studies, innovative developments for novel therapeutic products and strategies for drug development.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement