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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

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.

Clinical Supply Systems

This Guide is in Draft 1 development. The external review of the draft is planned for second quarter 2013.

Currently, there is no industry guideline or standards for clinical supply information systems. This can often make efficient information sharing, data exchange, and controls between internal and external systems difficult. These challenges are largely due to differences in system design including: data nomenclature; data formats and structures; and business, quality, and regulatory rules and controls.

This Good Practice Guide will assist companies when:

• Evaluating the purchase of a Commercial-Off-The-Shelf (COTS) system
• Designing a custom system or customizing a COTS system
• Interfacing with other internal or external systems

Commissioning and Qualification of Pharmaceutical Water and Steam Systems Revision

Draft 1 of this Good Practice Guide is in development. The external review of the draft is planned for second quarter 2013.

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.

Decommissioning of Pharmaceutical Equipment and Facilities

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

The Guide Team is in the process of developing its Document Plan.

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 1 of this Good Practice Guide will be undergoing industry review during the second quarter 2013.

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.

Technology Transfer Revision

Draft 1 of this Good Practice Guide is in development. The external review of the draft is planned for second quarter 2013.

This Guide revision will provide a generic framework and set of best practices to enable successful and efficient execution of a technology transfer project, i.e., the systematic transfer of product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization.

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.

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