Quality Assurance/Quality Control

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

Companies can benefit from developing a single programmatic approach to a GxP training matrix.

Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.

All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.

Data integrity is crucial in unlocking novel data-based insights.

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

Advanced analytical tools generate more data in today’s labs than ever before.

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

A structured cleaning procedure is essential to ensure the effective cleaning of equipment.

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

The industry is taking steps to automate the final product inspection process for complex therapeutics.

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Environmental monitoring data can help keep sterile environments sterile.

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Data from environmental monitoring can assist in keeping sterile environments sterile.