| PEER-REVIEWED RESEARCH |
Mohamad J. Altamimi, Kim Wolff, Gary P. Martin, Paul G. Royall
This study investigated the stability of solid lactose stored under high temperature and humidity conditions.
read more
| QUALITY: RISK-BASED PREDICTIVE STABILITY |
Helen Williams, Dennis Stephens, Megan McMahon, Elke Debie, Fenghe Qiu, Cherokee Hoaglund Hyzer, Lois Sechler, Rachel Orr, Debra Webb, Yan Wu, David Hahn
A survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
read more
| QUALITY AGREEMENTS |
Susan J. Schniepp
A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.
read more
Susan Haigney
Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.
read more
| FACILITY MODERNIZATION |
David M. Marks
The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
read more
| PROCESS CONTROL AND AUTOMATION |
Caroline Hroncich
Industry experts discuss IIoT and its impact on pharmaceutical manufacturing.
read more
| DATA INTEGRITY |
Darren Barrington-Light
Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.
read more
| FORMULATION |
Matthew Greene, Joanne Ratcliff, PhD
The authors discuss the challenges of capsule filling in preclinical and clinical studies.
read more
Adeline Siew, PhD
Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.
read more
| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.
read more
| TRACK AND TRACE |
Agnes Shanley
As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
read more
Agnes Shanley
Johnson & Johnson Supply Chain (JJSC) and the distributor AmerisourceBergen launched a four-week pilot program to test GS1’s EPCIS standards and to see how effectively data could be transferred between the two partners.
read more
Agnes Shanley
The author discusses the results from TraceLink and Actionable Research's Global Drug Supply, Safety, and Traceability Report.
read more
| TROUBLESHOOTING |
Richard Denk
The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.
read more
| REGULATORY WATCH |
Jill Wechsler
Manufacturers face uncertainty over imports, regulatory policies, and field inspections.
read more
| OUTSOURCING OUTLOOK |
Jim Miller
Moving global manufacturing operations may be more complicated than it appears.
read more
| ASK THE EXPERT |
Siegfried Schmitt
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
read more
| FROM THE EDITOR |
Rita C. Peters
Drug type, potential sales, and ownership factor in the race to get drugs to market.
read more
| PRODUCT SPOTLIGHT |
The OCEASOFT Loading Bench is an innovation for cold-chain monitoring management for transportation and high-volume shipment.
read more
The Pharmafill TC4 Tabletop electronic tablet counter from Deitz Co. automatically counts pills, tablets, capsules, softgels, caplets, lozenges, and other solid oral-dose products and fills them into bottles.
read more
Ross, Charles & Son offers a variety of mixers for mixing and blending applications.
read more
The Rainin SmartStand from Mettler Toledo includes four pipette holders.
read more
|
