Dynamic DRUMBEAT® for Pharmaceuticals
Drumbeat
Dimensions, Inc. Announces Release of
Dynamic Drumbeat® for Pharmaceuticals V2.2
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 V2.2
The following new Regulations were added to Dynamic DRUMBEAT® for Pharmaceuticals 2.2:
-
Latin American GMPs (Ministry of Health, National
Sanitary Surveillance Agency Resolution RDC No. 210 August 4, 2003)
-
Updated version of the EU GMPs
-
Updated version of the Japanese GMPs
-
Enhanced navigation features have been added
The following new Regulations were added to Dynamic DRUMBEAT® for Pharmaceuticals 2.1:
-
EU Guide Annex 8 (1992) – Sampling of Starting and Packaging
Materials
-
EU Guide Annex 16 (2001) - Certification by a Qualified Person and Batch Release
The following Regulations were updated in
Dynamic DRUMBEAT® for Pharmaceuticals 2.0:
-
The Japanese GMP Regulations
-
Rules Governing Medicinal Products In The European Community
Volume IV
Lists of regulatory guidance documents were added to the specific DRUMBEAT® Concepts as Additional References. Menus were revised to accommodate added regulations. The
User Guide was revised to address changes to the product. New DRUMBEAT® Concepts were added based on analyses of the added new regulations.
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® 95 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)
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