Case Studies and White Papers

Case Studies

Establishing a Virtual EU Quality Assurance Function

PharmaLex Ireland established and acted as an EU virtual Quality Assurance function for a US-based biopharmaceutical company seeking to launch their first product into the EU and Switzerland using a self-commercialisation model. With significant regulatory strategy and Quality Management Systems expertise, PharmaLex Ireland defined and implemented the target operations model for the EU and Swiss markets. Upon successful product launch, PharmaLex Ireland international assumed responsibility for product complaints, defects and recalls in the EU.

New Product Development and Commercialisation Roadmap

PharmaLex Ireland was engaged to work with stakeholders at the company to improve the existing roadmap of the New Product Development and Commercialisation (NPDC) process. The client’s current roadmap did not enable them to identify the dependencies between the various activities involved in developing a new product and preparing for commercialisation to the level of detail required. The client need to manage the process in a streamlined manner, across functions, defining milestone reviews ad stage gated decision points in a multi-functional manner.

Process Control Strategy

PharmaLex Ireland was approached by an established global biopharmaceutical company for assistance in developing an integrated Process Control Strategy framework to replace the firm’s fragmented risk assessment programmes. This was with a view to facilitating streamlined and compliant Technology Transfer and Process Validation within the organisation.

White Papers

Aseptic Processing: Key differences between the EU and US FDA

This Whitepaper dissects and discusses in detail a number of key differences between EU and US aseptic processing requirements, based on the authors’ collective experience. Each key area is then supplemented by a summary of the differences in tabulated format which provides a highly useful reference for any aseptic manufacturer.

The interface between Good Clinical Practice and Good Manufacturing Practice

A key part of planning for a clinical trial is ensuring that the Investigational Medicinal Product (IMP) is of sufficient quality and quantity for the full duration of the study. It is not unusual for a study to be delayed because sufficient IMP is not available. This article addresses some of the challenges associated with the preparation of an IMP for a clinical trial.

Human Error in Pharmaceutical Manufacturing

In this article we look at the common causes of Human Error in pharmaceutical manufacturing and outline an approach to reducing these errors with an objective to offer you: an insight into the common causes of Human Error in the area of pharmaceutical manufacturing; to provide you with a defined approach to investigating risk influencing factors and root cause; reducing Human Error; and sustaining error reduction within your own company.

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