Quality Systems

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Select Suppliers with Demonstrated Expertise to Avoid Sourcing “Bad” APIs

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Locking Fraudulent Materials Out of the Supply Chain

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer. 

Successful Technology Transfer

Sanjay Konagurthu is senior director, Pharma Services Group at Thermo Fisher Scientific, Bend, Oregon. 

Derek Gallo is director, global technology transfer at Thermo Fisher Scientific, Greenville, SC. 

Successful technology transfer depends on the ability to anticipate risks and plan ahead.

Technology Transfer: Best Practices in Operational Development

Michael Jovanis is vice-president of Vault Quality, Veeva Systems, jovanis@veeva.com.

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.

Digitizing to Modernize Manufacturing

Beverly Nickerson, PhD, is an associate research fellow in analytical research and development at Pfizer Inc., Eastern Point Road, Mail Stop 4086, Groton, CT 06340, tel. 860.441.0668, fax 860.715.8004, beverly_nickerson@groton.pfizer.com.

Anster Charles was a graduate student at the University of Missouri’s Chemistry Department, Columbia, MO.

Carlos Lee works for Lyndra Therapeutics, Watertown, MA.

Gail Johnson works for Pfizer Worldwide Research and Development in Groton, CT.

John Warzeka works for Pfizer Worldwide Research and Development in Groton, CT.

Laboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.

Speeding Sample Preparation and API Extraction from Solid Oral Dosage Formulations

Microsaic Systems showcased its new MiD ProteinID point-of-need mass spectrometer at Pittcon in Philadelphia, PA, from March 18–21, 2019.

New Protein Characterization Technique Unveiled at Pittcon 2019

The company is recalling Levoleucovorin Injection, 250 mg/25 mL because of copper salts found during stability testing.

Mylan Institutional LLC Recalls Levoleucovorin Injection

The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.

Hospira Issues Recall Due to Particulate Matter

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.

Quality Assurance/Quality Control