spacer
home > pmps > winter 2019 > supply forecast
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Supply Forecast

Packaging any pharmaceutical product can be a complex process. Ensuring a drug is packaged in compliance with the marketing authorisation and in a manner appropriate to environmental conditions requires detailed knowledge and experience, as well as having sufficiently trained staff and suitable facilities. This challenge is even greater if multiple drugs are being packaged for multiple markets at a single manufacturing site.

However, packaging products for clinical trials is arguably the most complicated and high-risk type of packaging work carried out in the pharma industry. The additional complexity introduced when there are numerous clinical sites means a detailed understanding of the regulations covering trials, as well as comprehensive knowledge of the study design and clinical protocol, is absolutely essential.

Various considerations in relation to packaging clinical supply will be discussed in this article, including the challenges associated with blinding supply and the impact that looming deadlines, such as that of serialisation, could have on the timescales and the overall cost of clinical trials. Overcoming these complexities through the introduction of new practices, such as just-in-time labelling, will also be outlined.

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
Colin Newbould is Director of Regulatory Affairs and QP Services at Wasdell Group. He is also one of Wasdell’s QPs for certification to the European market. Colin has over 20 years’ experience in the pharma industry, and, having previously held management positions at PCI Pharma Services, Penn Pharmaceutical Services, and Catalent, Colin also has expertise in facility design and start-up, high potent manufacturing, managing supply chain quality, risk management, and continuous improvement. He holds a BSc in chemistry with analytical chemistry and toxicology, is a current management committee member of the Pharmaceutical and Healthcare Sciences Society, and has previous terms with the Pharmaceutical Quality Group.
spacer
Colin Newbould
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Merck Launches ADC ExpressTM Services to Accelerate Pre-clinical Conjugation Candidate Selection

• Provides rapid production of antibody drug conjugates (ADCs) for best candidate selection • Established platform technology to reliably scale target molecules • Reduces time to clinic through comprehensive ADC services from pre-clinical to commercial from a single source
More info >>

White Papers

Characterisation of Biopharmaceutical Proteins

Reading Scientific Services Ltd (RSSL)

Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the protein�s primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.
More info >>

 
Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement