 |
|
 |
||||||||||||||||||
|
Baseline Guides |
||||||||||||||||||
Baseline® Pharmaceutical Engineering Guides for New and Renovated FacilitiesCreated in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline® Guides offer practical answers to the complex, dynamic challenges facing facility designers today. In addition to providing an understanding of products and processes, they also offer an outline of architectural and utility systems needed to meet government requirements. Additionally, they address GMP and non-GMP regulations and detail facility commissioning and qualification. Baseline® Pharmaceutical Engineering Guides
|
||||||||||||||||||
 |
Published: June 2004 Pages: 196 Table of Contents The Biopharmaceutical Manufacturing Facilities Baseline® Guide explores products and facilities that house biotechnological processes. More specifically, it applies to process design ties to facility design, controlled processing, preventing contamination, and segregation and flow. |
Order the bound version from the ISPE On-line Store
Coming Soon: secure PDF* for immediate download
The Biopharmaceuticals Baseline Guide is used in association with ISPE training course Biopharmaceutical Manufacturing Facilities. Attendees of the training course receive a complimentary copy of this publication.
Volume 6: Biopharmaceuticals Bound / Electronic Set
 |
The electronic version of the Baseline® Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document* of the Guide. |
Order the bound / electronic set from the ISPE On-line Store
* System requirements and user information for the electronic document.
Baseline® Pharmaceutical Engineering Guides
for New and Renovated Facilities
Volume 5: Commissioning and Qualification
The Commissioning and Qualification Baseline® Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER).
Published: March 2001
Pages: 142
Table of Contents
Order the bound version from the ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
The Commissioning and Qualification Baseline Guide is used in association with ISPE training courses Basic Principles of Commissioning and Qualification and Application of Commissioning and Qualification. Attendees of the training course receive a complimentary copy of this publication.
Volume 5: Commissioning and Qualification Bound / Electronic Set
|
The electronic version of the Baseline® Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document* of the Guide. |
Order the bound / electronic set from the ISPE On-line Store
* System requirements and user information for the electronic document.
Baseline® Pharmaceutical Engineering Guides
for New and Renovated Facilities
Volume 4: Water and Steam Systems
The Water and Steam Systems Baseline® Guide is intended for the design, construction, and operation of new water and steam systems. The purpose of this Guide is to focus upon engineering issues and provide cost-effective water and steam systems. The Guide is intended primarily for regulatory compliance for the domestic US market, and follows US standards and references. Issues relating to Europe are discussed in the Guide's appendix.
Published: January 2001
Pages: 228
Table of Contents
Order the bound version from the ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
The Water and Steam Systems Baseline Guide is used in association with ISPE training courses Pharmaceutical Water Generation and Pharmaceutical Water Operation. Attendees of the training course receive a complimentary copy of this publication.
Volume 4: Water and Steam Systems Bound / Electronic Set
|
The electronic version of the Baseline® Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document* of the Guide. |
Order the bound / electronic set from the ISPE On-line Store
* System requirements and user information for the electronic document.
Baseline® Pharmaceutical Engineering Guides
for New and Renovated Facilities
Volume 3: Sterile Manufacturing Facilities
 |
Published: January 1999 Pages: 166 Table of Contents The Sterile Manufacturing Facilities Baseline® Guide addresses the design, construction, commissioning, and qualification of facilities designed for aseptic processing of formulated products. The Guide is designed for use by industry for the design, construction, commissioning, and qualification of new or renovated aseptic/sterile manufacturing facilities. |
Order the bound version from the ISPE On-line Store
Available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
Sterile Manufacturing Facilities Revision
The Sterile Manufacturing Facilities Baseline Guide is used in association with ISPE training course Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation. Attendees of the training course receive a complimentary copy of this publication.
Baseline® Pharmaceutical Engineering Guides
for New and Renovated Facilities
Volume 2: Oral Solid Dosage
 |
Published: February 1998 Many Oral Solid Dosage (OSD) facilities run multiple products in processing areas designed for quick turnaround without unacceptable risk of product exposure (i.e., dust and cross-contamination). Additionally, potent or toxic active ingredients are becoming increasingly common and present their own design challenges. The Oral Solid Dosage Baseline® Guide assists professionals by establishing consistent and minimum parameters for facility design, which address these concerns and meet GMP requirements. |
Order the bound version from the ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
Baseline® Pharmaceutical Engineering Guides
for New and Renovated Facilities
Vol. 1, 2nd Edition: Active Pharmaceutical Ingredients
Revision to Bulk Pharmaceutical Chemicals
ISPE Members only: Download Chapter One now!
 |
Published: June 2007 This revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, (originally entitled Bulk Pharmaceutical Chemicals). The ISPE API Baseline Guide also incorporates and builds on new regulations and guidance, such as:
|
Key features of the Guide include:
- Active Pharmaceutical Ingredient characterization
- Critical process steps
- Potential contamination
- Good Engineering Practice
- Levels of protection
- Critical process parameter
- Critical instruments
- Critical unit operation (new)
- Contamination review (new)
- Design qualification (new)
- Intended patient use (new)
- Direct, indirect, and no impact systems (new)
- Critical and non-critical components (new)
- Facility designation (new)
- Process Analytical Technologies (new)
- Process review (new)
- Risk to patient (new)
- Understanding of process (new)
In addition, the revision of this Guide has provided the opportunity to incorporate specific current Good Manufacturing Practices (cGMP) considerations for pharmaceutical manufacturing regions outside the U.S., and has recognized and adopted harmonization work, such as the ICH (International Conference on Harmonisation) Q7 Good Manufacturing Practices for Pharmaceutical Ingredients.
Order the bound version from the ISPE On-line Store
Also available as a secure PDF* for immediate download
from Techstreet/Thompson Scientific
Baseline Guides® Under Development
For more information, contact ISPE Customer Service at customerservice@ispe.org
Indicates content available to ISPE members only.
Oral Solid Dosage Forms Revision
The first draft of the Oral Solid Dosage Forms Baseline® Guide revision is undergoing further development. The OSD Task Team is coordinating 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.
Sterile Manufacturing Facilities Revision
The Sterile Manufacturing Facilities Baseline® Guide revision Task Team is developing a complete draft to provide to the FDA for detailed review and comment. 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.
Commissioning and Qualification Revision
The draft Commissioning and Qualification Baseline® Guide revision is undergoing development and preparation for external review. This revision 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).
Water and Steam Systems Baseline Guide Revision
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.
Packaging, Labeling, and Warehousing Operations
The Packaging, Labeling, and Warehousing Operations Baseline® Guide has completed FDA review and is undergoing final edit for publication. 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.
Maintenance
The Maintenance Baseline® Guide is undergoing final edit and preparation for FDA technical review. 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.
Laboratories
The Laboratories Baseline® Guide has undergone review by specified reviewers. The Task Team will incorporate 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.
Risk-MaPP
The Risk-MaPP Baseline® Guide Task Team is assembling drafts of the introductory and regulatory chapters, executive summaries, and descriptive outlines of other chapters to facilitate discussion of regulatory issues between the Task Team and regulatory agencies. 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.
Download the Complimentary Webinar: Introduction and Update on ISPE’s New Risk-MaPP Baseline® Guide
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.
|
 |
|
