spacer
home > pmps > summer 2018 > evaluating the impact
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Evaluating the Impact

What was the strategic driver behind your research?

Julie Suman: Several complex challenges are facing injectables component partners, from increased safety and quality requirements to development of sensitive drug formulations, which necessitate the creation of more inert solutions with greater regulatory standards. Drug product manufacturers need flexibility to select components that meet their sterilisation requirements.

What is the regulatory case for extractables and leachables?

Injections and injectable suspensions have the highest degree of concern associated with the various routes of administration, as far back as the guidance document issued by the FDA in May 1999. Current expectations have increased with new methodology defined in the US Pharmacopeia and Product Quality Research Institute (PQRI) parenteral and ophthalmic guidelines. There is also a high likelihood of packaging component/dosage form interaction, hence the intense scrutiny in this area.

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
Julie Suman, RPh, PhD, is the Founder of Next Breath, an Aptar Pharma business, and serves as its President. Julie holds a BS in pharmacy from Duquesne University, US, and a PhD in pharmaceutical sciences from the University of Maryland, Baltimore, US. She is co-editor of the Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, US. Julie is also a member of the Parental Drug Association Visible Particulate Taskforce.
Print this page
Send to a friend
Privacy statement
News and Press Releases

c-LEcta signs Europe sales and distribution agreement with VWR for c-LEcta’s DENARASE®

• DENARASE® is now available through VWR’s sales channels in Europe • VWR, part of Avantor, is a leading global provider of product and service solutions to laboratory and production customers • Cooperation harbors the potential for c-LEcta’s product to gain additional share in a highly dynamic market
More info >>

White Papers

Mouse Models for Evaluation of Vaccines and Therapeutics Against Staphylococcal Infections

IBT Bioservices

Introduction Staphylococcus aureus (SA) is a ubiquitous, formidable Gram-positive pathogen associated with skin and soft tissue, as well as lifethreatening systemic infections. SA is a leading cause of hospital- and community-associated infections worldwide, affecting humans and animals. The wide range of pathologies reflects the diverse abilities of this microbe to escape the innate and adaptive immune response using virulence factors. Since its first emergence in the 1960s methicillin-resistant SA (MRSA) has become endemic in hospitals and healthcare settings worldwide. In the 1990s, community associated MRSA strains (CA-MRSA) emerged, and are spreading worldwide posing a major global challenge.
More info >>

 
Industry Events

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement