|
|
|
Pharmaceutical Manufacturing and Packing Sourcer
|
A pharmaceutical product’s ability to perform its purpose depends on its quality; the user expects the product to be safe, therapeutic and completely fit for function. To meet these criteria, it needs to be intrinsically stable, free of contamination and must reproducibly deliver the therapeutic benefit claimed on the label or in the product information leaflet to the consumer over the period of its shelf life. Such a product is said to deliver its quality through its design, hence the phrase ‘Quality by Design’ (QbD). QbD focuses on integrated product development, commencing at the concept stage (1). These principles have been adopted by the FDA for the discovery, development and manufacturing of drugs and have been developed further for biopharmaceutical products (2,3).
When a product is developed with raw material selection in mind, designing quality and removing formulationassociated risks are key considerations. To this end, using the best materials available is crucial to help manage these aspects of chemistry. Depending on how the drug is to be administered (topically, orally or parenterally), raw material choices and their attributes need to be deliberated, especially where key ‘natural’ materials are to be used. A control strategy needs to be developed for the entire process, including tight supervision on the excipients’ specifications, to ensure consistent quality and product stability over its shelf life.
As such, excipient selection plays a key role in determining the performance of a drug – not only in delivering the efficacy required, but also maintaining this over the product’s lifetime.
|
Read full article from PDF >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
News and Press Releases |
 |
Exploristics present the Welcome Organisation with Christmas Shoeboxes
More info >> |
|
 |
White Papers |
 |
|
Is Your Biobank Ready for the Challenge of Biomarker-based Research?
BioFortis
Targeted and personalized studies with well-defined patient segmentation biomarkers are becoming the norm in clinical trials. This increased interest in molecular biomarker studies necessitates a rigor and sophistication in sample management within the clinical trial context that is often not supported either by traditional clinical trial management software (CTMS), or biobanking systems. Download our Next Generation Biobanking whitepaper and learn about how to overcome the key challenges in clinical trial sample management from working in a distributed network of partners and stakeholder to managing consents and generating scientific insights.
More info >> |
|
 |
Industry Events |
 |
BioProduction Congress 2017
17-18 October 2017, Convention Centre Dublin, Ireland
Save the date to attend the 16thAnnual BioProduction Congress; Europe’s leading and largest event
for a comprehensive update on all aspects of large scale mammalian and
microbial biological manufacturing.
More info >> |
|
|
