Quality Systems

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

Articles

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.

Channeling Customer Complaints into Quality

Agnes Shanley is senior editor of Pharmaceutical Technology.

Rather than isolating the user in a virtual world, mixed reality allows contextualized data to be shared in real time, improving assays, standard
operating procedures, workflows, and overall tech transfer.

Mixed Reality Gains a Foothold in the Lab

Amy Thanavaro, PhD, is a group leader scientific-Analytical Services & Development at STERIS.

Chris Edlin, PhD, is currently director of drug development and head of Pharmaceutical Sciences in Respiratory R&D for Teva Pharmaceuticals Ireland.

Dijana Hadziselimovic is a technical services laboratory specialist for the Life Sciences Division at STERIS.

Adeyinka Aina, PhD, MRSC, is an innovation fellow at the Pharmaceutical Manufacturing Technology Centre, University of Limerick.

Paul Lopolito is a technical services senior manager for the Life Sciences Division at STERIS.

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Rethinking Cleaning Validation for API Manufacturing

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

Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.

Maintaining GMPs Requires Continued Vigilance

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

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

FDA Uses New Pilot Plan for the Development of Guidance on Neurological Treatments

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

Biosimilars Raise Analytical and Policy Challenges

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

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

Change Control for Standard Operating Procedures

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.


Making Decisions Based on Risk

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.