Guidance Documents in Development

ISPE Guides and Concept and Discussion Papers go through a robust guidance document process involving pharmaceutical industry professionals. The Guides and Papers are authored by pharmaceutical industry representatives and subject matter experts (SMEs).  Once authored, Guides are reviewed and approved by pharmaceutical industry representatives in the same subject matter but not the group who authored the Guide.  As for the Papers, they're reviewed and approved by a designated focus group of industry SMEs.

Baseline® Guides  |  GAMP® Good Practice Guides  |  Good Practice Guides

Good Practice Guide: Advanced Therapeutic Medicinal Product Manufacturing

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide is in development.

The goal of this Guide is to provide a best practice for addressing the key design and operational challenges for manufacturing operations focused on personalized medicine product platforms.

Good Practice Guide: Advancing Pharmaceutical Quality – CAPA [working title]

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide has completed industry review and the Team is going through comments.

This Guide provides an introduction to the Advancing Pharmaceutical Quality (APQ) Program, an industry-led benchmarking program that is focused on quality management maturity and aligned with ICH Q10 Pharmaceutical Quality System. The focus of this Guide is the assessment and improvement of the CAPA (Corrective Action/Preventive Action) system using the APQ Assess, Aspire, Act & Advance Framework.

Good Practice Guide: Controlled Temperature Chamber Mapping & Monitoring (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Document Plan is under review and the team is being formed. 

This Guide will be revised to reflect current best practice and align content to the C&Q Baseline® Guide 2nd Edition.

Good Practice Guide: Equipment Reliability

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide has completed industry review and the Team is going through comments. 

This Good Practice Guide is being updated to reflect current technology and best practices. Planned updates include, for example: content related to improving efficient use of revised temperature utilities and fan drives; content on risk-based approaches; and content on area differential pressures, airlocks, and system settings/alarms.  

Good Practice Guide: HVAC (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide is in development.

This Good Practice Guide is being updated to reflect current technology and best practices. Planned updates include, for example: content related to improving efficient use of revised temperature utilities and fan drives; content on risk-based approaches; and content on area differential pressures, airlocks, and system settings/alarms.

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide is in development.

The publication of ICH Q10 in 2008 introduced the formal designation of Knowledge Management (KM) as a key enabler for an effective Pharmaceutical Quality System. Since then, the industry has acknowledged the importance of managing knowledge across the lifecycle to enhance process understanding, improve decision making and enable more robust risk management. ICH Q10 and Q12 discuss the expectations for firms to proactively manage product and process knowledge citing the potential of more efficient and effective regulatory oversight; however, there are currently few resources, and no industry guidance available, which address the role of Knowledge Management specifically for the pharmaceutical industry.

This Good Practice Guide will provide practical real-world guidance on Knowledge Management including what it is, why it is important, and the tools and processes that can be applied.  This is especially important for KM where awareness is increasing and emerging in regulatory guidance. The scope of this guide will primarily focus on pharmaceutical development, commercialization, and manufacturing and is intended for those who have a role in generating and curating product and process knowledge or have a role in QMS development (science and technology, manufacturing, quality, regulatory, etc.).

Good Practice Guide: Maintenance (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide has completed industry review and the Team is going through comments. 

This Guide is intended to be used as a tool for the development, implementation, and execution of a maintenance program in a pharmaceutical manufacturing environment. The Guide aims to be flexible to permit organizations to develop solutions to maximize performance and minimize the total cost of asset ownership. This second edition will provide updates to address new concepts and best practices within the industry, current regulatory requirements, and updates in technology and applications.

For more information, contact ISPE at Ask@ispe.org


Guidance Document Draft KEY

Proposal: First stage of the Document Development Process which provides the Guidance Documents Committee (GDC) with sufficient information to determine if the proposed topic justifies an industry need to create a guidance document.

Document Plan: Second stage of the Document Development Process which contains a proposed Purpose and Objectives, Scope and Key Concepts, Structure (may include Outline), Team Organization with Core Team identified, Stakeholders, and Project Planning.

Draft 1: First draft which includes main body of the document and drafts of all chapters and appendices (circa 80% complete). This draft is issued for industry review giving Members the opportunity to provide comment. Regulatory agencies may also provide feedback at this time.

Draft 2: Final draft which includes all industry comments incorporated, as appropriate, and final technical edits completed. Proceeds to GDC for review/approval, then into production for publication.

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