Quality Systems

Courtney Soulsby is sector director, Healthcare & Life Sciences, BSI.

Articles

A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines. 


A New Route to Pharma GDP Compliance and Standardization 

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

Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.

The Importance of Batch Record Reviews During Audits

Michael Moedler, PhD, is head of Training at Lonza Biologics Operations Visp.

Helene Pora, PhD, is vice-president of Technical Communication and Regulatory Strategy at Pall Corporation.

Training is crucial for supporting GMP operations in commercial-scale bioprocessing.

Accelerating Workforce Training on Single-Use Technologies

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

Susan J. Schniepp, distinguished fellow at Regulatory Compliance 
Associates, details regulatory requirements for developing a quality manual.

What’s in Your Quality Manual?

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

The Data Relationship

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

Mylan Recalls Semglee Prefilled Pens

The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination. 

Lohxa Recalls Senna Syrup

Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.

Without a Particle of Doubt

Feliza Mirasol is the science editor for 

Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.

Automation Helps Streamline Glycosylation Monitoring Workflow

Hari Narayanan, PhD, is product marketing manager at Thermo Fisher Scientific.

Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.

Quality Assurance/Quality Control