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

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

Plan
Draft 1
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Draft 2
Approval
Production
 

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

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: Water and Steam Systems (Third Edition)

Plan
Draft 1
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Draft 2
Approval
Production
 

Draft 1 of this Guide is in development.

The Guide aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet cGMPs and comply with existing regulations and related guidance. This third edition will provide updates to address recent changes within the industry, changes in compendia, and changes in technology. This includes, but is not limited to, the acceptance of non-distillation-based methods for production of WFI as well guidance for elemental impurities (ICH Q3D). The content will also be reorganized, streamlined, and will refer to relevant ISPE Good Practice Guides.

Good Practice Guide: Asset Management

Plan
Draft 1
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Draft 2
Approval
Production
 

Draft 1 of this Guide is almost complete and due to be released for for industry review and comment. 

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: Cleaning Validation [working title]

Plan
Draft 1
Review
Draft 2
Approval
Production
 

Draft 1 of this Guide is in 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: Critical Utilities Inspection

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Draft 1
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Draft 2
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Production
 

Draft 1 of this Guide is in development.

This guide aims to provide guidance and examples of best practices to prepare for and (participate/host) a regulatory inspection as it relates to critical utilities.

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 almost complete and due to be released for industry review and comment.

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)

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Draft 1
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Approval
Production
 

Draft 1 of this Guide is in development. 

Description to come.

Good Practice Guide: Process Validation

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Draft 1
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Approval
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Draft 2 of this Guide is undergoing revision in preparation for final GDC review

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: Technology Transfer (Third Edition)

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

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. “Technology transfers” may utilize either the outputs of process and method development activities, and/or documentation of established processes and methods.

The knowledge of the product and the manufacturing process is the basis for transfer to a different location, which could be a different site or country or a different facility on the same site, where a process or analytical procedure will be operated. This third edition will focus on how technology transfer can be achieved and will be updated to ensure alignment with relevant guidance publications, terminology used by industry and regulators, and reference to practical case study examples.

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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