GxP Lifeline September 2008 - Your Resource for Life Science Intelligence

September 2008


Benefits of MasterControl to Senior Management

Feature Article:

Creating Value Solutions Through Assessment and Risk Reduction

For Pharmaceuticals:

Analytical Method Validation: What is Expected?

For Medical Device:

The Sentinel Initiative

For Blood & Biologics:

Writing and Enforcing Effective SOPs

At the Heart of Clinical Research

The Protocol

Did You Know?

SAS Datasets in Version 5 Transport File

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Creating Solutions Through Assessment

Whether we are assessing vendors like software developers whose products are used in the automated processes for manufacturing of pharmaceuticals or medical devices, or the less technologically driven processes like pharmaceutical distribution channels for supply chain integrity, the process of inspection can help create useful data to support development of technology for specific uses.

One common thread throughout different audit processes is the maintenance of sound audit practices, standards and guidelines. This has been illustrated through regulatory action and oversight. Regulations, Standards and Guidelines, as published by the Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), state regulatory bodies like Boards of Pharmacy, the Healthcare Distribution Management Association (HDMA), National Association of Boards of Pharmacy (NABP) and other associations and regulatory agencies affect the way audits are conducted and what standards or guidelines are used to measure compliance or performance.

For Pharmaceuticals: Analytical Method Validation: What is Expected?

Improper analytical method testing can yield dire consequences for companies whose laboratories neglect proper validation procedures. FDA warning letters, poor reproducibility and production disruptions are results of organizations that fail to provide assurance that their test methods have been appropriately validated or verified. Industry expert Michele Piepoli discusses requirements and expectations of regulatory bodies regarding the performance and documentation of an analytical method validation.

For Medical Device: The Sentinel Initiative: Will it Finally Result in Postmarket Protection and Premarket Improvement?

Like any other organization, CDRH understands that even the best of plans are of little use without the right technology and the Sentinel system would certainly be the far-reaching technology required for greater postmarket surveillance throughout the lifecycles of a medical device. It is hard to imagine such a large-scale system, however. What would the system do and how would it be created?

For Blood & Biologics: Writing and Enforcing Effective SOPs

There is no document more critical to a health care company's compliance and business success than standard operating procedures (SOPs). SOPs define how an employee performs a process or even her own job. Failure to have well-written and clearly defined SOPs is a compliance risk and a business risk. Yet many companies chance a regulatory rumble because they fail to write accurate SOPs.

At the Heart of Clinical Research: The Protocol

The protocol is core to every clinical research study; it is the plan. The protocol is used in designing the study, selecting investigative sites, developing the data collection tools, describing the study procedures and the analysis plan. Institutional Review Boards (IRBs) or Ethics Committees use the protocol as the basis for approving whether a study can be initiated. A well-constructed protocol can ensure common understanding of the study objectives and procedures to be implemented, thereby improving quality and saving time and effort for those using it. Clearly, it is one of the most important documents used in clinical research.

Did You Know?

Did you know that if you are submitting your eCTD to the FDA, non-clinical and clinical data should be provided as SAS datasets in version 5 transport file (XPT) format?

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