Baseline Guides® Under Development

For more information, contact ISPE at 1-813-960-2105, or Ask@ispe.org

Volume 2: Oral Solid Dosage Forms Revision

The Rev C draft of the Oral Solid Dosage Forms Baseline® Guide revision is undergoing final edit and preparation for FDA technical review.

The OSD Task Team has coordinated with the Task Teams of the RISK-MaPP Baseline® Guide and the Sterile Baseline® Guide revision to align areas of commonality. The revised document is expected to provide additional detail, consider new technologies, and further globalize the scope of the content.

Volume 3: Sterile Manufacturing Facilities Revision

The Rev C draft of the Sterile Manufacturing Facilities Baseline® Guide revision is undergoing final edit and preparation for FDA technical review.

The Task Team has already received a high level of input from the FDA throughout the Guide’s development. The Task Team is coordinating with the Task Teams of the Oral Solid Dosage Forms Baseline® Guide revision and RISK-MaPP Baseline® Guide to align areas of commonality. The revised document will maintain the Guide’s alignment with current regulations. Several authors of the original Guide are contributing to this revision.

Now available: Baseline Guide: Sterile Revision Outline

Volume 4: Water and Steam Systems Baseline Guide Revision

The draft Water and Steam Systems Baseline® Guide revision is close to Rev B and will be available for external review by SME’s later this year.

The existing Guide and Appendix will be updated to incorporate current trends and recent developments related to pharmaceutical water and steam systems. Information will be added where appropriate, including guidance on laboratory water systems, rouge monitoring and control, and continuous monitoring. Existing information will be updated to bring this guide into agreement with other published documents, such as the ISPE Good Practice Guide for the Commissioning and Qualification of Pharmaceutical Water and Steam Systems.

The original Guide is widely recognized as an industry-standard guide for pharmaceutical water and steam systems design, construction, and qualification. The Team plans to incorporate the necessary updated information, and maintain the format and outline (with some adjustments to the contents where needed) of the existing Guide.

This revised Guide is not intended to address any aspect of water and steam system validation. This is a subject that has been well defined by the FDA and other authorities, and for which substantial guidance documentation exists.

Now available: Baseline Guide: Water and Steam Revision Outline

Volume 5: Commissioning and Qualification Revision

The Commissioning and Qualification Baseline® Guide will undergo revision in conjunction with the development of the Volume 12 Baseline® Guide on Specification, Design, and Verification. The structure and general approach of this revision will remain the same and will be led by Team members that also worked on Volume 12. The C&Q revision will clarify change management and change control, describe enhanced documentation, include impact assessment, and focus on good industry practice.

A document will be developed to explain the relationship between the Volume 5 C&Q Baseline® Guide and the Volume 12 Specification, Design, and Verification Baseline® Guide.

Volume 7: Packaging, Labeling, and Warehousing Facilities (PACLAW)

The Packaging, Labeling, and Warehouse Facilities Baseline® Guide Rev C draft is undergoing final review with the FDA.

This is a “horizontal” Guide and addresses support systems and functions common to all pharmaceutical manufacturing facilities. As with other Baseline Guides, the development team has worked closely with the FDA throughout development of the Guide.

Volume 8: Maintenance

The Maintenance Baseline® Guide Rev C draft is undergoing final technical review at the FDA.

The Guide is a tool for the development, implementation, and execution of a maintenance program in a pharmaceutical environment. It focuses on maintenance in critical and non-critical GxP areas. Whereas differences between GMPs, GLPs, GCPs, and other regulatory areas may exist, the Guide defaults to a common standard to help ensure compliance in all such areas.

Volume 9: Quality Laboratory Facilities

The Quality Laboratory Facilities Baseline® Guide Rev B draft has undergone review by specified reviewers. The Task Team is incorporating comments where appropriate before final edit and preparation for FDA review.

The scope of this Guide is intended to encompass GMP/GLP-regulated laboratory facilities (QA/QC laboratories, CT laboratories) and to apply to quality control, stability, clinical, and basic research laboratories for products in development or marketed for human consumption.

Volume 10: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

The Risk-MaPP Baseline® Guide Rev C draft is undergoing review by the Technical Documents Executive Committee in preparation for the FDA.

The Task Team has representation from the US, Europe, and Japan. The Guide provides a mechanism that allows manufacturers to ensure that multiple products of varying risk can be safely produced in the same facility. The Guide outlines a risk management approach to ensure that cross contamination is at or below acceptable limits for multiple product facilities.

Learn More: Complimentary Webinar available Introduction and Update on ISPE’s New Risk-MaPP Baseline® Guide

Volume 11: Biopharmaceutical Process Development and Manufacturing

The Task Team of this new “Process and Technology” Baseline® Guide is in the process of developing its first draft.

This Guide will focus on the scope of work involved in product and process development and manufacturing for biopharmaceuticals. Areas to be covered will include Quality by Design, general biopharmaceutical processes, upstream and downstream processing, process support and utilities, scale-up, and tech transfer. Appendices will cover tools used in process and product development, process automation and control, and a discussion on disposables. ISPE is seeking volunteers to be part of this Baseline® Guide’s Task Team. E-mail CVs to Guides@ispe.org.

Now available: Bioprocess Outline

Volume 12: Science and Risk-Based Approach for the Specification, Design, and Verification of Facilities, Utilities, and Equipment Systems

“An ICH-Based [Alternative] Approach to Commissioning and Qualification”
The Draft of this new Guide has undergone external review and the Task Team is currently working on incorporating the comments. This document will become the twelfth in the ISPE Baseline Guide Series and is a result of the FDA’s risk-based initiatives and the new ASTM standard.

This document will describe a risk and science-based approach to be used by the pharmaceutical industry for the design, construction, commissioning, and qualification of new or renovated facilities and equipment that have the potential to affect product quality and public health. It will incorporate and be based on the principles described in the ASTM Standard E55.03 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.” The approach described within this Guide also supports continuous process capability improvements and enables innovation such as the implementation of Process Analytical Technology (PAT).

A document will be developed to explain the relationship between the Volume 5 C&Q Baseline® Guide and the Volume 12 Specification, Design, and Verification Baseline® Guide.

Science and Risk-Based Cleaning Process Development and Validation

This new Guide is in the early stages of Rev A draft development.

This Guide will cover development of cleaning processes, cleaning validation, and use of statistics in cleaning validation and PAT. Key components are:

• Cleaning Process Development
• Cleanability Studies
• Health Based Safety Thresholds
• Cleaning Failure Modes and Effects Analysis
• Cleaning Process Performance Capability.

These activities develop scientific knowledge of cleaning processes and are ultimately linked to the protection of the patient.

Now available: ISPE Baseline Guide: Science and Risk-Based Cleaning Process Development and Validation Outline

ISPE Technical Document Draft KEY

Outline: (Taken from the DQPP) Made available on-line for the benefit of ISPE members to view the direction that a Task Team is taking in regard to a topic area. This also allows members to indicate their willingness to participate in the development of a Technical Document (where appropriate).

Rev A: First draft which includes drafts of the introductory chapter(s) and the regulatory chapter(s), plus executive summaries and descriptive outlines of other chapters; developed to facilitate discussion of regulatory issues between task teams and regulatory agencies.

Rev B: Second draft which includes main body of the document, complete drafts of all chapters, and appendices approximately 95% complete. Rev B is issued to specified reviewers (SME’s from appropriate ISPE’s Communities of Practice) for opportunity to provide comment.

Rev C: Final draft which includes all industry comment incorporated, as appropriate, and final technical edits completed. If a Baseline® Guide, Rev C is issued to the FDA for technical review. Completed document is then fed into the ISPE Publication Process.

 Indicates content available to ISPE members only.