Quality Systems

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.

Anticounterfeiting: In Search of the Unhackable

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

QbD and API Process Development: A Marriage of Chemistry and Engineering

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation. 

Annex 1 Misses the Mark

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

Modular Automated Technology Allows Multiple Bioreactor Sterile Sampling

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

Baxter Extends Recall of Nexterone

In a roundtable Q&A with biopharma executives, the vulnerability and challenges of dealing with extractables and leachables in single-use bioreactor bags are explored.

The Challenge of Dealing with E&L in Single-Use Bioreactors

The company is voluntarily recalling product because of glass particles found in vials.

AuroMedics Pharma Recalls Ampicillin and Sulbactam for Injection

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

Compounded Sterile Products Recalled

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

Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.

Meeting Data Integrity Requirements

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

Process validation is an extension of biologics development processes. 

Quality Assurance/Quality Control