Quality - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

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

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.

Baxter Recalls Peritoneal Dialysis Solution

August 15, 2014

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

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.

Quality by Design in Contract Service Relationships

August 1, 2014
Pharmaceutical Technology

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction

July 2, 2014

Pharmaceutical Technology

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

Securing the Supply Chain

July 2, 2014

Pharmaceutical Technology

Regulators and industry leaders take on the task of securing the drug supply chain.

FDA Issues Guidance on Identifying Suspect Drugs

June 17, 2014
PTSM: Pharmaceutical Technology Sourcing and Management

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

Wockhardt Cited by FDA for Quality Control Failures

June 4, 2014

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

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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 LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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