Standard Operating Procedures (SOPs)

Best Practices in the QC Micro Laboratory

August 01, 2019

BioPharm International

Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.

Channeling Customer Complaints into Quality

April 01, 2019

BioPharm International

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Where Automation Meets Skill Set

April 01, 2019

BioPharm International

A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.

Taking Stock of Biologic Fill/Finish Best Practices

February 01, 2019

BioPharm International

To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.

Change Control for Standard Operating Procedures

November 01, 2017

BioPharm International

The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.

First USP Workshop of its Kind Focuses on Particulates in Biologics

September 14, 2017

Along with particulate control and determination, speakers at the June conference in Rockville, Maryland, examined the role of protein aggregation and immunogenicity

Bioburden Control in the Biopharmaceutical Industry

September 01, 2017

BioPharm International

Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.

Troubleshooting Lab Operations: Be Proactive, Not Reactive

June 01, 2017

BioPharm International

This article reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way, while also taking a proactive, preventive approach to managing atypical laboratory scenarios.

Staffing and Preparation for Audits

January 01, 2017

BioPharm International

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to handle audits and inspections during business expansion.

Nurturing the Relationship Between Industry and Regulators

December 01, 2016

BioPharm International

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.