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Articles

A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.

Ensuring Quality Control in Vendor Relationships

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has made two significant changes to its new 2019 Code of Practice with the aim of boosting business integrity on a global scale.

New Code of Practice in Place to Boost Global Business Integrity

Matthew Weinberg is chief executive officer of The Weinberg Group.

Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.

Simulating Reality in Mock Inspections

James O’Brien is global MES business unit lead, Zenith Technologies.

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.

Planning a Successful MES Deployment

Martin O’Rourke, PhD, is senior director, Oncology In-Vitro Biosciences, Integrated Drug Discovery at Charles River Laboratories.

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

The Power of In Vitro Assays in Immuno-Oncology

Thomas Ruebekeil is vice-president of Project Management at Vetter Pharma-Fertigung GmbH & Co. KG and is responsible for investment projects and technical project management at Vetter in Ravensburg, Germany. 

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations. 

Modular Facility Design Maximizes Space Flexibly

Jonathan Martinez is Director of Operations at PK Technology, which provides mechanical integrity consulting and inspection services and has developed and licenses intelliSPEC, a digital data management system and mobile platform.

Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.

Complying with Good Engineering Practices for Mechanical Integrity of Process Equipment

Dave Williams, vice president of software development, Westfalia

How warehouse execution systems can help in case of a drug recall. 

Managing Pharmaceutical Recalls with Automation

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the  United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

How to Achieve Pharmaceutical Dust Control

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.

Best Practices