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GAMP® Good Practice Guides Under Development
For more information, contact ISPE at Ask@ispe.org
Testing of GxP Systems Revision
In 2005, ISPE released the GAMP Good Practice Guide on Testing of GxP Systems. This guide was provided electronically as a download available free of charge to ISPE members. It was made available in this format in recognition of the provisional status of the document, which captured the initial thoughts and concepts around testing GxP systems.
During the years since the document was written, there has been an increased focus on the use of risk-based approaches in industry, accompanied by a significant regulatory and industry activity affecting computerized systems, and much evolution in testing good practice, including:
- GAMP 5
- ICH Q8, Q9, Q10
- ASTM E2500
- Adoption and implementation of Process Analytical Technology and Quality by Design
- Increased industry focus on risk-based approaches
- Increased use of non-linear development lifecycles
- Increased use of computerized test tools
- Revised EU GMP Annex 11
ISPE is pleased to announce that an expert Task Team is in the process of revising the document to provide definitive guidance around effective, risk-based testing of GxP systems. This guide will be available for purchase in either printed (bound) or electronic format, in keeping with the existing range of ISPE GAMP Good Practice Guides.
The new guide will contain pragmatic guidance on defining the scope of testing, the strategy, the test plan, recording the results, dealing with deviations and reporting the outcome. The central premise of the guide is that the aim of testing is to discover defects in order to mitigate risk. It will cover conventional linear sequential development methodologies as well as the iterative and incremental approaches. Practical guidance will be included on the selection, benchmarking, assessment, control and use of automated testing tools. Appendices will provide worked examples for different types of systems, focussing on the risks associated with any unique features of the system type along with suggestions on how to mitigate the risks. The examples cover systems applying Process Analytical Technology, cloud computing, packaged systems, analytical instruments, infrastructure, process control systems, configurable IT systems and end user developed applications.
The guide has completed its industry review; the quantity and complexity of comments received will determine exactly when this guide will be released. Visit this space for updates!
Validation of Laboratory Computerized Systems Revision
This Guide revision is undergoing preparation for publication.
The ISPE GAMP® Good Practice Guide: Risk-Based Approach to Compliant Laboratory Computerized Systems Document (working title) will address laboratory computerized systems used within the regulated life science industries. This Guide is a revision of the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems. It is intended as a supplement to GAMP 5.
This Guide will provide an approach to risk assessment processes which can be used to determine a rational, scalable approach to compliance and demonstrating fitness for intended use, by building upon GAMP 5.
Patient safety is affected by the integrity of critical records, data, and decisions, as well as those aspects affecting physical attributes of the product. This Guide will seek to develop a rational approach to the implementation of compliant laboratory computerized systems and to provide guidance to address strategic and tactical computer system compliance issues of current interest, including:
- Identify characteristics that distinguish various laboratory computerized systems.
- Develop a rationale for scaling the effort associated with the implementation of compliant laboratory computerized systems.
- Develop a strategy for supplier assessment to supplement company specific implementation activities.
- Describe the GAMP 5 risk assessment approach as it applies to laboratory computerized systems.
- Define necessary controls to maintain laboratory computerized systems in a state of compliance.
- Examine the traditional System Development Life Cycle (SDLC) and its applicability for most Laboratory Computerized Systems and the System Implementation Life Cycle (SILC).
- Recommend activities to be performed when a laboratory computerized system is no longer suitable for its intended use.
ISPE Technical 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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