Quality Systems

Ke Wang, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Fangfang Liu, PhD, is manager of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Fasheng Li, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Aili Cheng, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Brad Evans, PhD, is associate director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Jingnan Zhang, PhD, is manager of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Articles

A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation. 

Removing Subjectivity from the Assessment of Critical Process Parameters and Their Impact

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Auromedics Pharma Recalls Linezolid Injection Due to Mold Contamination

The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.

AuroMedics Pharma LLC Recalls Pantoprazole Sodium for Injection

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

Quality Issues Found at Canadian Facility

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

Contract Manufacturing Raises Regulatory Concerns

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

What’s in Your SOP?

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Evaluating Surface Cleanliness Using a Risk-Based Approach

The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.

Baxter Recalls NEXTERONE

Scott Barnard is market strategy director for UL Compliance to Performance.

Investing in a single source enterprise-wide LMS to fuel risk management and mitigation offers multi-dimensional return on investment.

The Value of LMS in Driving Effective Risk Mitigation Principles through QMS and QRM

FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.

Quality Assurance/Quality Control