Dynamic DRUMBEAT^® for Pharmaceuticals

Drumbeat Dimensions, Inc. Announces Release of
Dynamic Drumbeat^® for Pharmaceuticals V2.3

Dynamic DRUMBEAT^® for Pharmaceuticals is designed for those who produce pharmaceutical products primarily for U.S., Canadian, European, Japanese, and Latin American markets.

Producers of commercial pharmaceutical products are expected to comply with explicit GMPs regulations. A major element of most regulatory requirements involves the formal use of hundreds of specific Standard Operating Procedures (SOPs). Analyses of these SOPs can provide an accurate indication of the level of regulatory compliance.

What’s New in V2.3

The following new document was added to Version 2.3 of Dynamic Drumbeat for Pharmaceuticals:

• ICH Q9: Quality Risk Management (2005)

The following Regulations were updated in Version 2.3 of Dynamic Drumbeat for Pharmaceuticals:

• 21CFR 211 including changes to the following sections:

• 211.67(a)

• 211.68 (added new section (c))

• 211.72

• 211.84(d)(6)

• 211.94(c)

• 211.101(c), (d)

• 211.103

• 211.110(a)

• 211.113(b)

• 211.182

• 211.188(b)(11)

Rules Governing Medicinal Products In The European Community Volume IV including changes to the following sections:
Added new sections in Chapter 1 to address Quality Risk Management
EU GMPs Annex 1: Manufacture of Sterile Medicinal Products

Menus were revised to accommodate added regulations.

User Guide was revised to address changes to product.

The following new Drumbeat Concepts were added:

• 6.28.01 Management Review

• 6.28.02 Continuous Improvement

• 6.28.03 Management Commitment

• 6.28.04 Resource Management

• 6.28.05 Product Realization

• 6.28.06 Process Performance and Quality Monitoring

• 6.28.07 Knowledge Management

• 6.30 Corrective and Preventive Action

• 6.32 Risk Management

• 6.32.01 Risk Management Plan

• 6.32.02 Risk Management File

• 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

Modified wording for the following DBCs due to regulatory changes:

• 1.05 Major Equipment Use, Cleaning, and Maintenance Log

• 5.11 Dual Witnessing (Verification)

• 5.11.01 Weighing Components

• 5.11.02 Charging-In of Components

• 5.11.05 Verifying Yield Calculations

• 5.30 Filters for Liquid Filtration

Dynamic DRUMBEAT^® for Pharmaceuticals is an electronic set of DRUMBEAT^® tools that enables you to:

• Rapidly identify Quality System deficiencies
• Organize, optimize, and manage SOPs
• Facilitate strategic audit planning and reporting
• Simplify development of comprehensive CGMP Training Programs
• Reduce the risk of non-compliance

Dynamic DRUMBEAT^® for Pharmaceuticals includes the following regulatory references linked to DRUMBEAT^® Concepts:

• 21 CFR Part 211 (2006)– Current Good Manufacturing Practice for Finished Pharmaceuticals
• 21CFR Part 11 (2006) – Electronic Records; Electronic Signatures
• EU Guide to GMPs for Medicinal Products (2005)
• EU Guide Annex 1 (2003) – Manufacture of Sterile Medicinal Products
• EU Guide Annex 2 (1992) – Manufacture of Biological Medicinal Products
• EU Guide Annex 8 (1992) - Sampling of Starting and Packaging Materials
• EU Guide Annex 11 (1992) – Computerized Systems
• EU Guide Annex 15 (2001) - Qualification and Validation
• EU Guide Annex 16 (2001) - Certification by a Qualified Person and Batch Release
• Canadian Good Manufacturing Guidelines (2002 v2)
• ICH Q7A GMP Guidance for Active Pharmaceutical Ingredients (2001)
• Japanese Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-drugs (2005)
• Latin American Regulations RDC 210 (2003)
• FDA System Based Inspection Compliance Policy Guide (2002)

Dynamic DRUMBEAT^® for Pharmaceuticals is revised as regulations change, to reflect the latest regulatory environment.

System Requirements for Dynamic DRUMBEAT^® for Pharmaceuticals include:

Operating Systems

• Microsoft^® Windows^® 2000 or newer

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

Hardware Requirements

• Dynamic DRUMBEAT^® for Pharmaceuticals uses the minimum requirements for your computers' operating system.

Additional Software

• Adobe^® Acrobat^® Reader™ 7.0 or newer*
• Microsoft^® Word^® 2000 or newer
• Microsoft^® Excel^® 2000 or newer

*Free download available from the Adobe website (Version 8.0 Included on CD-ROM)