Quality - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

Investigational Product Expiry Management

September 12, 2014

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses the use of interactive response technologies in investigational product expiry management.

The Relevance of Industry Technical Associations

September 2, 2014

Pharmaceutical Technology

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

Healthcare Reform in China

September 2, 2014

Chinese healthcare reforms may be a double-edged sword for foreign companies.

A Case for an FDA Dean's List

September 1, 2014

Pharmaceutical Technology

FDA is moving in the right direction in terms of implementing stratification by levels of compliance across pharmaceutical manufacturing sites. However, quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.

Need for Supply Chain Transparency is Acute

September 1, 2014

Pharmaceutical Technology

Biopharma manufacturers must reduce risk in their complex supply chains and establish effective monitoring and control systems.

Baxter Recalls Peritoneal Dialysis Solution

August 15, 2014

Baxter voluntarily recalls two lots of peritoneal dialysis solution because of the presence of particulate matter.

USP Center in Ghana Receives International Lab Accreditation

August 15, 2014

The Center for Pharmaceutical Advancement and Training receives a top international laboratory accreditation for quality control testing.

Amgen Recalls Aranesp Prefilled Syringes

August 15, 2014

Amgen has issued a voluntary recall of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes in several countries because of the presence of visible particulates.

Cubist Pharmaceuticals Recalls CUBICIN

August 8, 2014

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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