Quality & Compliance

4 April 2013

The Research Pharmacy: Quality Management System Approach for Common Noncompliance Issues

By Jim Moran, Erika Stevens and Christina Eberhart

Consider the following hypothetical situation: During a routine inspection, FDA requests and inspects investigational pharmacy policies and procedures as well as product accountability and handling. Were investigational products accounted for and stored appropriately? Does the investigational pharmacy have a quality management system or risk management policy? How are corrective and preventive actions tracked? Will the investigational pharmacy be cited with a Form 483? Read More...

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24 July 2012

The Problem with Audit Reports

By Joseph McMillian, MA

When an audit is conducted, company management expectations are simple: They want to know whether there is a problem, how big it is and whether or not it is being fixed. All too often, audits, and their reflection in follow-up communications, fail to live up to that role because most audit processes and reports fail to take full advantage of, and communicate, the information they gather. However, without a denominator, the auditor and the audit report recipients will have difficulty determining an overall compliance profile for the site or the processes being audited. Read More...

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