Guidance Documents in Development

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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

Baseline Guide: Active Pharmaceutical Ingredients (Third Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production

This Guide is in the proposal stage.

Description to come.

Baseline Guide: Commissioning and Qualification (Second Edition) [working title]

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on the Document Plan for this revision.

Description to come.

Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 2 of this Guide is undergoing revision based on further regulatory input.

The purpose and objective of the revision is to align the document with the recent EMA GMP updates and to better align topics to the ICH Q9 model. This will provide industry a model to meet the EMA’s new requirement for risk assessments to determine if shared facilities can be safely used. It also continues to provide a model to meet the FDA’s GMP requirement for “such other control systems” to prevent mix-ups or contamination during production.

Baseline Guide: Sterile Product Manufacturing Facilities (Third Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production

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

The Sterile Product 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.

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Baseline Guides   |  GAMP Good Practice Guides  |  Good Practice Guides

GAMP Good Practice Guide: Electronic Records and Data Integrity

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 1 of this Guide is out for industry review and comment.

This Guide will provide practical guidance on meeting current regulatory expectations for the management of electronic records and the data underlying them, which includes the need for integrity, security, and availability throughout the required retention period. It will describe how a risk management approach may be used to ensure the compliance of regulated electronic records and signatures, including managing risks to integrity of underlying data, through the application of appropriate controls commensurate with the identified risks.

GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 2 of this Guide is undergoing revision based on industry feedback.

This Guide provides an understanding of the issues faced by teams that are tasked with completing a global deployment of an IT system, in particular, to provide some insight into addressing issues of control and regulatory compliance efficiently and effectively. The Guide encompasses a wide range of regulations and guidelines, including US FDA, EU GMPs, PIC/S Guidance, Health Canada GMP and ICH.

GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 2 of this Guide is undergoing revision based on industry feedback.

This Guide provide comprehensive guidance on meeting current regulatory expectations for compliant IT infrastructure platforms, including the need to identify, qualify and control those aspects impacted by GxP.

GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data: Good eClinical Practice

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 1 of this Guide completed industry review and the team is working through comments.

Clinical trials provide a unique challenge to technology suppliers and quality functions because every trial is its own project that investigates different aspects regarding the use of an investigational medicinal product, endpoint and/or indication. To address this challenge the framework must aim to safeguard patient safety and data integrity within clinical trials, while allowing for individual trial needs to be addressed. The purpose of this Guide is to provide a cost-effective framework of good practice to ensure that computerized systems used in clinical trials are fit for intended use, compliant with applicable regulations, current guidelines (incl. ICH), and aligned with the risk-based principles of GAMP 5.

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Baseline Guides   |  GAMP Good Practice Guides  |  Good Practice Guides

Good Practice Guide: Asset Management

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on the Document Plan for this new Good Practice Guide.

Description to come.

Good Practice Guide: Control of cGMP Cleaning and Cleaning Validation

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on the Document Plan for this new Good Practice Guide.

Description to come.

Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

Plan
Draft 1
Review
Draft 2
Approval
Production

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

The purpose of this guidance document will be to provide basic information required for the decommissioning of equipment and facilities and will provide templates, flowcharts, and example documents currently in use in the US and Europe. Topics to include are common practices, closure planning, GxP decommissioning, GEP decommissioning, asset disposal, and demolition/remediation.

Good Practice Guide: HVAC and Process Equipment Filters

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 1 of this Guide is due to be issued for industry review and comment in September.

This Good Practice Guide is intended to be a reference on the selection, specification, testing and operation of filters in pharmaceutical applications. It explains the principles and objectives of filter testing during manufacturing and on site.

Good Practice Guide: Maintenance (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on the Document Plan for this new Good Practice Guide.

Description to come.

Good Practice Guide: Manual Sampling

Plan
Draft 1
Review
Draft 2
Approval
Production

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

Sampling means collecting a small portion of a larger stream that accurately reflects the content of the larger stream. Sampling is one of the largest sources of variability and inconsistency in the industry. Regardless of whether sampling closed systems such as pharmaceutical water, steam, or process gas streams, the extraction of truly representative samples poses unique challenges in the industry. ISPE’s Critical Utilities (CU) Community of Practice is tackling this complicated issue of sampling and has formed a team of experts to develop and publish a Good Practice Guide on Sampling focused on best practices and covering all aspects of sampling.

Good Practice Guide: Packaging, Labeling, and Warehousing Facilities (Second Edition)

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on the Document Plan for this new Good Practice Guide.

Description to come.

Good Practice Guide: Process Validation

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on Draft 1 of this new Good Practice Guide.

The quality and supply of drug products has been a concern of regulatory agencies for many years, resulting in tightened expectations of suppliers to ensure patient safety based on sound scientific proof. All drug companies have expended efforts to comply with regulatory expectations resulting in various approaches to achieving compliance. Each of the various approaches have value but none have provided a holistic approach to process validation. This Guide will provide step by step implementation approaches, standardized platforms and fundamental PQLI process understanding to establish accepted process validation standards. Additionally this Guide will provide clear and concise process validation terminology for a compliant stepwise drug substance/drug product process validation.

Good Practice Guide: Reliability

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on the Document Plan for this new Good Practice Guide.

Description to come.

Good Practice Guide: Single Use Technologies

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 1 of this Guide has completed industry review and the team is working through comments.

This Guide is intended to provide a background in disposable technology while proposing implementation strategies with sound testing criteria. The Guide highlights methods applied or considered for handling single use components from an overview of feasibility of using the products to disposing of used products. Guidance for proposed model solvent extractable and leachable families with respect to vendor testing are outlined and proposed for new industry standardization. Topics presented in the Guide include pre-clinical stage, tech transfer from clinical to commercial operations, and project management strategies for commercial change control for single use applications. Quality and regulatory considerations are the focus of this Guide with respect to single use technologies.

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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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