Quality Standards Development

In October 2006, the FDA finalized the Guidance Document, “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations” describing ways to implement quality systems and reduce risk analysis in the pharmaceutical industry. One of the major areas addressed by this new guidance document and other quality system references is management responsibilities.

The new guidance document states,

“management is responsible for establishing the quality systems structure appropriate for the specific organization”.

Drumbeat Dimensions, Inc. can help you to structure a management system by working with you to develop Quality Policy and Procedure Guidelines (QPPGs) that define the quality standards for production and control of pharmaceutical drug products. These standards are based on international regulatory requirements and are aimed at helping to reduce systemic quality issues by ensuring that all plant sites operate under one set of quality standards.

Drumbeat Dimensions Inc.'s experienced professionals, working in partnership with the client, create quality standards by weaving client practices with worldwide regulatory requirements and current regulatory expectations in an easy to follow format. Quality Standards can be used to develop local plant site procedures that are

• consistent with company management philosophy
• establish a consistent basis for internal audits
• serve as a foundation for training programs

Working with Drumbeat Dimensions Inc. allows the client to focus on running their business while Drumbeat Dimensions Inc. focuses on developing the Quality Standards.

For more information about Drumbeat Dimensions, Inc. Quality Standards Program, use our Contact Form or call 860.448.4923.