Baseline Guides® Under Development
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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.
Now available: Baseline Guide: Sterile Revision Outline
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.
Now available: Baseline Guide: W&S Revision Outline
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.
Now available: Baseline Guide: Bioprocess Outline
ISPE Good Practice Guides Under Development
Good Engineering Practice
The ISPE Good Practice Guide: Good Engineering Practice has undergone review by specified reviewers and the Task Team is incorporating comments and enhancing the Appendices. In addition to comparing the current draft with existing international documents, a European sub-team has been integrated to provide input. The Guide describes the fundamental elements of GEP as they should exist in pharmaceutical and related industries. It provides a benchmark tool for assessment of GEP within any organization and a model as a means of identifying possible improvements to practices.
Heating, Ventilation, and Air Conditioning (HVAC)
The Task Team is preparing the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) for external review. The Guide aims to provide a common understanding of critical HVAC issues and a set of common practices to address these issues, gathering together information which is currently included in appendices of the various Baseline Guides into a single resource. The Guide will provide supporting information and HVAC practices and will explore critical and non-critical HVAC issues for the production of pharmaceuticals, biopharmaceuticals, and medical devices.
Now available: ISPE Good Practice Guide: HVAC Outline
Science and Risk-Based Cleaning Process Development and Validation
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 Good Practice Guide: Science and Risk-Based Cleaning Process Development and Validation Outline
Cold Chain Management
The industry needs specific guidance on how to attain consistency in the transport of the products requiring specific parameters to maintain safety, efficacy and quality of the medicinal product during transportation from the manufacturer to the consumer. This new Guide is in the early stages of development. Areas to be covered are:
- Equipment
- Regulatory Requirements
- Qualification of Packaging
- Anti-counterfeiting systems
Goal is to provide practical guidance in the area of cold chain management, with examples of typical documents.
Now available: ISPE Good Practice Guide: Cold Chain Management Outline
Direct Impact Process Gas Systems
This new Guide is in the early stages of development. Sections to be included are:
- global direct impact gas standards used in the pharmaceutical and biotechnology industry and regulatory considerations
- gas options and facility system conceptual planning – raw gas through high purity gases
- gas generation system design options and processes
- gas distribution system options and processes
- major direct impact gas system issues – microbial control strategies, materials of construction options, instrumentation, construction issues and related issues including selection of gas filters
- commissioning and qualification of direct impact gas systems including determination of system boundaries (no, indirect and direct impact systems), non-critical and critical components, critical quality attributes, sampling programs, etc.
- gas system operation and maintenance considerations
Pharmaceutical Testing Laboratories
The Task Team is preparing the ISPE Good Practice Guide: Pharmaceutical Testing Laboratories for external review. The Guide focuses on key elements necessary to maintain a high level of cGMP compliance and produce accurate, precise, and consistent test results. The two main objectives for the Guides are to provide guidelines for the compliant operation of a Quality Control Laboratory designed to meet the regulatory requirements, and to provide guidance for any laboratory performing analysis for the pharmaceutical industry, by assisting cGMP laboratories in designing and maintaining compliant systems.
