Quality Assurance/Quality Control

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.

Automation can be balanced with operator oversight.

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Aseptic techniques must be practiced throughout all stages of biologics production.

Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors.