Guidance Documents in Development

Print this page         

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

Plan
Draft 1
Review
Draft 2
Approval
Production

The Team is working on the first Draft of this revision.

The purpose of this Guide is to provide a detailed description of a science and risk-based approach for the Commissioning and Qualification of Facilities and Equipment, providing an update to the Baseline® Guide on C&Q that is adequate to allow the development and implementation of an efficient effective program.

The Guide will address a number of the areas that traditionally cause concern if engineering documents are to be used to support Qualification – e.g. Good Documentation Practice, Definition of test record document format and signature requirements, and effective use of vendor assessments.

The goal of the Team is to produce a document that describes a lean effective program that may be used to provide confirmation that facilities and equipment are fit for purpose.

Baseline Guide: Sterile Product Manufacturing Facilities (Third Edition)

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 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.

[Return to top]

Baseline Guides   |  GAMP Good Practice Guides  |  Good Practice Guides

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 in production for publication.

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

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.

[Return to top]

Baseline Guides   |  GAMP Good Practice Guides  |  Good Practice Guides

Good Practice Guide: Asset Management

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 1 of this Guide is in development.

Asset Management provides the overarching framework for all other initiatives and processes required to enable the alignment of business processes and quality management systems. This Guide will provide a roadmap for aligning best practices as they relate to the way physical assets are managed in the pharmaceutical/biotechnology industry.

Driving overall costs down in a unified fashion, vs. a siloed approach, drives value creation that supports the organizations objectives without hurting the overall operations. At the heart of asset management is the alignment of all aspects of an organization to ensure the activities of the organization create value.

This Guide will provide a “how to” framework for applying asset management best practices, based on the ISO 55000 standards, in the Pharma/Biotech industry.

Good Practice Guide: Control of cGMP Cleaning and Cleaning Validation

Plan
Draft 1
Review
Draft 2
Approval
Production

Guide Team is being formed to begin on Draft 1 development.

The purpose of this Guide is to provide up to date information and knowledge concerning cleaning and the validation of cleaning activities within the Pharmaceutical Industry. The Guide will be applicable to not only small molecule manufacturing activities but also biological materials as well as the many secondary dosage forms manufactured within the global Pharmaceutical Industry and is equally applicable to Active Pharmaceutical Ingredients (APIs).

The scope will cover the wide range of cleaning activities within the pharmaceutical Industry and their validation. It will detail the types of industry practices related to controlling cross contamination by effective cleaning and by the suitable selection of cleaning processes, materials, sample locations, type of samples and acceptance criteria which are required to meet the different global regulatory standards including the latest guidance from the EU regarding Permitted Daily Exposure (PDE) limits.

Critical areas of cross contamination and resulting Maximum Allowable Carryover (MACO) calculations will be discussed in detail and guidance on appropriate acceptance criteria will be provided. While related to product contact equipment the Guide will also reference the cleaning of non-product equipment and facilities so as to clarify the differences in respect of cleaning validation for product contact and no-product contact equipment.

Good Practice Guide: Equipment Reliability

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 1 of this Guide is in development.

This Guide aims to provide professionals with guidance on the application of equipment reliability concepts in the context of the pharmaceutical, medical device, biologics, and/or blood industries and will be applicable to facilities, utilities, systems, and equipment assets. The Guide is intended to be flexible enough to allow organizations to develop and apply solutions for asset management and maintenance strategies that optimize equipment performance and the total cost of asset ownership. This new guidance document applies an equipment lifecycle approach to asset management, and it will provide connectivity to other ISPE Good Practice Guides to show how the various aspects of asset management, reliability, and maintenance relate.

Good Practice Guide: HVAC and Process Equipment Filters

Plan
Draft 1
Review
Draft 2
Approval
Production

Draft 1 of this Guide is in development.

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

Draft 1 of this Guide revision is in development.

Description to come.

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: Single Use Technologies

Plan
Draft 1
Review
Draft 2
Approval
Production

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

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.

[Return to top]

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.

[Return to top]

My ISPE

  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile