It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Digitalization of QbD Risk Assessments

Topic

Ania Szymanska is site head of Quality at Scorpius Biomanufacturing.

Articles

What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem? 

How to Evaluate a CDMO’s Commitment to Quality

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

EMA Issues Reminder Over Paxlovid Risks

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

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

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

AbbVie Gains Nod from NICE for Tepkinly

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.

Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

Compounding Overview: Primary Considerations for the Workplace

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

EMA Given Grant to Support Establishment of African Medicines Agency

Cheryl Barton is director of PharmaVision, 

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

MHRA’s New International Recognition Procedure

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

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments