Quality Systems

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

Articles

FDA inspections can create uncertainty. Supervision of the contract manufacturer 
is crucial in ensuring compliance. 


Bioprocessing Facilities and FDA Inspection Problems

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

New agency leadership is pressed to promote innovation while addressing safety and quality issues.

FDA Faces Challenges After Gottlieb

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.


The Auditor Vs. Inspector Issue

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

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

Avoiding Excipient Variability

Agnes Shanley is senior editor of Pharmaceutical Technology.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

Using the Multiple Attribute Method for Process Development and Quality Control

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

Getting a Handle on Biopharm’s Most Critical Quality Attributes

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

Sagent Pharmaceuticals, Inc. Recalls Ketorolac Tromethamine Injection, USP, 60mg/2mL

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

Managing Biologic Equipment Cleaning

The company is voluntarily recalling the product due to difficulties with the delivery system.

AmEx Pharmacy Recalls Bevacizumab 1.25mg/0.05mL 31G Injectable

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.


Quality Assurance/Quality Control