Dynamic DRUMBEAT^® for Pharmaceutical Clinical Trial Supplies

Dynamic DRUMBEAT^® for Pharmaceutical Clinical Trial Supplies is designed primarily for those who produce pharmaceutical Clinical Trial Supplies, and secondarily for those who use Clinical Trial Supplies in the execution of human clinical trials.

Clinical Trial Supplies producers are subject to explicit GMP regulations, most of which match those applicable to commercial products; however, some require special interpretation, especially for Clinical Trial Supplies intended for Phases I and II.

Clinical Trial Supplies producers, who make, test, and release materials, often include some combination of Pharmacists, Chemists and/or Engineers, Analytical Scientists, and QA/QC experts. Clinical Trial Supplies producers usually report to the Sponsor.

Dynamic DRUMBEAT^® for Pharmaceutical Clinical Trial Supplies is an electronic set of DRUMBEAT^® tools that enables you to:

• Rapidly identify risks of regulatory non-compliance
• Search and compare SOPs across multiple plant sites, and against worldwide regulatory requirements
• Organize, optimize, and manage SOPs
• Facilitate strategic audit planning and reporting
• Simplify development of comprehensive Training Programs in Good Manufacturing Practices relevant to the manufacture and control of Clinical Trial Supplies
• Expedite development of a Quality Management System

Dynamic DRUMBEAT® for Pharmaceutical Clinical Trial Supplies includes the following regulatory references linked to DRUMBEAT^® Concepts:

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• 21CFR Part 11 – Electronic Records; Electronic Signatures
• 21CFR Part 312 - Investigational New Drug Application
• 21CFR Part 314 - Applications For FDA Approval To Market A New Drug
• 21CFR Part 320 - Bioavailability And Bioequivalence Requirements
• FDA Guideline On The Preparation Of Investigational New Drug Products
• EU Guide to Good Manufacturing Practice for Medicinal Products
• EU Guide Annex 1 – Manufacture of Sterile Medicinal Products
• EU Guide Annex 2 – Manufacture of Biological Medicinal Products
• EU Annex 8 – Sampling of Starting and Packaging Materials
• EU Guide Annex 11 – Computerized Systems
• EU Annex 13 - Manufacture Of Investigational Medicinal Products
• EU Annex 15 - Qualification and Validation
• EU Annex 16 – Certification by a Qualified Person and Batch Release
• Brazilian GMPs (Ministry of Health, National Sanitary Surveillance Agency Resolution RDC No. 210 August 4, 2003)
• Canadian Good Manufacturing Guidelines
• Japanese Regulations for Manufacturing Control and Quality Control of Drugs
• Japanese Regulations for Buildings and Facilities for Pharmacies etc.
• ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
• ICH Good Clinical Practice: Consolidated Guideline

New in Version 1.1:

The following new Regulations were added:

• EU Annex 8 – Sampling of Starting and Packaging Materials
• EU Annex 16 – Certification by a Qualified Person and Batch Release
• Brazilian GMPs (Ministry of Health, National Sanitary Surveillance Agency Resolution RDC No. 210 August 4, 2003)

The following Regulations were updated:

• The Japanese GMP Regulations
• Rules Governing Medicinal Products In The European Community Volume IV

Navigation buttons were added to each DRUMBEAT^® Concept page to simplify navigation including:

• Go to Next Concept
• Return to Previous Concept
• Go To DBC Concept List
• Return to Main Menu

EU Annex Menu was added to accommodate added regulations

User Guide was revised to address changes to product

The following new DRUMBEAT^® Concepts were added based on analyses of the added new regulations:

• 6.08.02 Quality Manual
• 6.28.01 Management Review
• 6.28.02 Continuous Improvement
• 6.30 Corrective and Preventive Action
• 6.31 Statistical Techniques
• 6.32 Risk Management
• 6.32.01 Risk Management Plan
• 6.32.03 Hazard Identification
• 6.32.04 Risk Analysis
• 6.32.05 Risk Evaluation
• 6.32.06 Risk Control
• 6.32.07 Risk Management Communication
• 6.32.08 Risk Review
• 7.01.02 Shipping
• 8.01.03 Confidentiality
• 8.01.04 Record Security
• 8.02.03 Reporting Adverse Events
• 8.07 Customer Feedback

ICH Good Clinical Practice: Consolidated Guideline was renamed ICH Q6 by ICH and the name change is reflected in the Dynamic Drumbeat for Pharmaceutical CTS.

Dynamic DRUMBEAT^® for Pharmaceutical Clinical Trial Supplies is revised as regulations change, to reflect the latest regulatory environment.

System Requirements for Dynamic DRUMBEAT^® for Pharmaceutical Clinical Trial Supplies include:

Operating Systems

• Microsoft^® Windows^® 95 or newer

Drumbeat Dimensions, Inc. recommends Windows^® 2000 or Windows^® XP

Hardware Requirements

• Dynamic DRUMBEAT^® for Pharmaceutical Clinical Trial Supplies uses the minimum requirements for your computers' operating system.

Additional Software

• Adobe^® Acrobat^® Reader™ 6.0 or newer*
• Microsoft^® Word^® 2000 or newer
• Microsoft^® Excel^® 2000 or newer

*Free download available from the Adobe website (Version 6.0 included on CD-ROM)

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