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

APQ Guide Series: Change Management

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide is in development.

This Guide is part of the Advancing Pharmaceutical Quality (APQ) Guide Series. APQ is an industry-led benchmarking program that is focused on quality management maturity and aligned with ICH Q10 Pharmaceutical Quality System. This Guide focuses on the application of the APQ framework to the change element system. 

Guide is in production for final publication. 

This Guide is part of the Advancing Pharmaceutical Quality (APQ) Guide Series. APQ is an industry-led benchmarking program that is focused on quality management maturity and aligned with ICH Q10 Pharmaceutical Quality System. This Guide focuses on the application of the APQ framework to management responsibilities and management review.

GAMP Good Practice Guide: Tech Innovation [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 and making updates to the Draft.

This Guide will align the concepts and terminology of recent regulatory and industry developments and cover the following: application of “critical thinking”, recognition of current FDA activity on Computer Software Assurance (CSA) approaches, importance of service providers including cloud service providers, and the evolution of approaches to software development including incremental and iterative models and methods, and increased use of software tools and automation to achieve greater control, higher quality, and lower risks throughout the life cycle.

Good Practice Guide: Controlled Temperature Chamber Mapping & Monitoring (2nd 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 will be revised to reflect current best practice and align content to the C&Q Baseline® Guide 2nd Edition.

Good Practice Guide: Good Engineering Practice 2nd 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 and making updates to the Draft.

This Guide is being updated to reflect current industry practice, particularly with respect to Baseline Guide Vol 5 C&Q 2nd Edition, development of an Engineering Quality Process (EQP), and the application of GEP as an enabler for QRM-based integrated C&Q. Additionally, the current revision of the GEP GPG extensively references risk management. Since the publication of the current revision, the industry has further defined the concepts and application of Quality Risk Management. In the absence of industry standards this revision will define acceptable practices but not to the extent that the Guide content becomes misaligned with current industry practices

Good Practice Guide: IP Reverse Logistics

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 2 of this Guide is undergoing revision in preparation for final GDC review.

Supporting drug reconciliation, returns and destruction is an often-overlooked final stage of clinical trial process that has been collecting more and more attention from regulators and inspectors. This Guide is a collection of best practices in the planning and execution of Reverse Logistics that will begin to help provide standards that in turn will build confidence within health authorities that it is a well-controlled process across the industry.

Good Practice Guide: Non-Distillation Based Water for Injection (WFI)

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide is in development.

This Guide will reflect current industry practice and provide additional details not covered in the Baseline Guide Vol 4 Water & Steam Systems 3rd Edition with regards to the specific topic of Non-Distillation based Water for Injection. The focus of the Guide will be on the generation as well as the impact it has on the systems upstream and downstream. The Baseline Guide Vol 4 does not go into details regarding the pros and cons of the technology and what companies should look for and what risks they may have when implementing this technology. This guide is required as global pharmacopeias (with exception of China) now are fairly harmonized in allowing non-distillation-based technologies to produce WFI. European Pharmacopeia (Ph. Eur.) being one of the last major pharmacopeias to allow this technology (01APR2017). There is currently an absence of unbiased industry guidelines regarding this topic and this document will define acceptable practices.

Guide: Adv Therapeutic Medicinal Products (ATMPs) – Autologous Cell Therapy

Plan
Draft 1
Review
Draft 2
Approval
Production
 

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

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.

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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