ISPE Good Practice Guides Under Development

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API Process Technology Roadmap – Facility of the Future

Following the comments received from the external review of the ISPE Good Practice Guide: API Process Technology Roadmap, the API Community of Practice Process Technology Subcommittee identified several potential areas for development which did not fit in with the structure of a single Guide on this topic. The content as it stands will be repurposed to create a series of ISPE Good Practice Guides

The first step in this development is now published as an article in Pharmaceutical Engineering ( 2 MB). This article provides the API COP’s perspective on what it thinks the Facility of the Future will look like and provides a link to a survey that is intended to allow members to provide their views of what the industry is thinking on this topic.

The purpose of this survey is to solicit feedback regarding key areas for industry to progress to enhance innovation, provide for sustainability, and meet the ever changing landscape of an API Small Molecule Plant of the future.

Applications in Single Use Technology – A Practical Guide for Quality, Regulatory, and Associated Implementation Strategies

Draft 1 of this Good Practice Guide is in development.

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.

Commissioning and Qualification of Pharmaceutical Water and Steam Systems Revision

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

This Guide is an update of the original publication, to include both traditional and science- and risk-based C&Q of water and steam systems.

Controlled Temperature Chambers

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

A Controlled Temperature Chamber is defined as a unit, equipment, or room in which temperature of an interior chamber is controlled/maintained/regulated to specific user requirements. The ISPE Good Practice Guide: Controlled Temperature Chambers provides guidance on good practices for the mapping of controlled temperature chambers, warehouses, and refrigerated storage areas used to store raw material, work in progress, or finished product and which operate under current Good Manufacturing Practice. The Good Practice Guide is based on the ISPE Concept Paper on Controlled Temperature Chamber Mapping and expands on the concept paper to include topics such as commissioning, testing strategies, acceptance criteria, qualification approaches, system monitoring, operational issues and periodic review.

Decommissioning of Pharmaceutical Equipment and Facilities

The Document Plan has been approved and the Team is working on Draft 1.

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.

If you are interested in participating with the development of this Guide, please email your contact details, a brief description of your experience, and how you would like to volunteer to GPG Leader Nick Haycocks at haycocks@amgen.com

Manual Sampling

Draft 1 of this Good Practice Guide is close to completion and external industry review is planned for second quarter 2014.

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.

Pharmaceutical Operations Management

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

The primary objectives of this Guide are to:

  • Provide guidance and support to pharmaceutical operations managers to be able to select the most appropriate solutions for the identification and completion of the objectives of their manufacturing operations within the framework of the entire organization. This includes stakeholders and regulatory bodies.
  • Provide operations management personnel with sound support in understanding how compliance and operational excellence can be achieved through a mutually beneficial approach between industry and regulatory, considering the extent of such tight regulation that currently exists in the pharmaceutical industry.
  • Define a common language and provide a guideline for performance measurement and improvement.
  • Identify new performance improvement tools, while clarifying what is and is not applicable in pharmaceutical operations.
  • Provide a reference or benchmark for pharmaceutical operations.

The scope of the document will range from global operations strategy to plant shop-floor execution and it will specifically address Operations Strategies, Supply Chain Management, Performance Measurement, and Performance Improvement Tools.

Sustainability

Draft 1 of this Good Practice Guide will be undergoing industry review during first quarter 2014.

This ISPE Guidance Document is unique; it is written to provide a reference manual on sustainability and energy efficiency; it provides background and guidance on what sustainability is and how processes and facilities may respond; including design and engineering influences and options, sustainable regulations, and assessment schemes as well as information on current best practices, and discussions on future opportunities.

It’s a must have for management looking at international expansion through to engineers and designers workingon a project.

ISPE 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.

Outline: Made available online for the benefit of ISPE members to view the direction that a Task Team is taking in regard to a topic area. This also allows Members to indicate their willingness to participate in the development of a Guidance Document (where appropriate).

Executive Summary: Drafts of the introductory chapter(s), the regulatory chapter(s), descriptive outlines of other chapters, and titles of proposed appendices; developed to facilitate discussion of regulatory issues between task teams and regulatory agencies, as well as, to further illustrate the direction of the guidance document to Members.

Draft 1: First draft which includes main body of the document and drafts of all chapters and appendices (circa 80% to 90% complete). This draft is issued for industry review giving Members the opportunity to provide comment.

Draft 2: Final draft which includes all industry comments incorporated, as appropriate, and final technical edits completed. Proceeds to GDEC for review/approval, then fed into the ISPE Publication Process. If a Baseline® Guide, this draft is issued to the FDA for technical review prior to ISPE Publication Process.

Last Update: 03 April 2014

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