Quality by Design

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

When it comes to getting the best out of quality by design, timing is everything.

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.

A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.

In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.

The agency now allows production of water for injection by non-distillation technologies.

The directorate is looking for experts to join the European Pharmacopoeia network.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.

Hedley Rees, managing director at PharmaFlow Ltd and a member of the CPhI expert panel, shares his views on pharmaceutical supply chain issues.

CPhI expert, Girish Malhotra, warns that without urgent regulatory reform, the industry would remain reluctant to make process changes that will improve manufacturing efficiency due to the financial and time constraints of re-approval.

Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.

EDQM clarifies elemental impurities guidelines for veterinary and other products.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.