ISPE COMMISSIONING AND QUALIFICATION GUIDE PDF

Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning and Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2 nd Edition Guide, ICH documents Q8 R2 , Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E Guidance is provided how to transition an organization's approach quality systems and establishing the appropriate of level of quality oversight for Commissioning and Qualification that incorporates a science and risk-based approach. NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course. This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event. Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach.

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By Steve Wisniewski , July 16, The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment. This guide defined a better understanding of baseline cGMP requirements through coordination with ISPE, industry, and global regulatory bodies. The guide defined a flexible and innovative lifecycle approach to facility, systems and equipment design, construction, commissioning, and qualification supported by the definition of key terms for consistent interpretation and application.

Beginning in industry began recognizing the importance of a science and risk-based qualification approach with a focus on Quality by Design that was built around risks to product quality and patient safety.

This move was primarily influenced by the following guidance documents:. The Guide defines the focus for the qualification effort as Critical Design Elements CDEs — Design function or feature of an engineered system that is necessary to manufacture products with the desired quality attributes consistently.

It is important to note that several concepts associated with the original guide have been retired with the application of the QRM approach. These include:. The URS document describes the intended purpose of the system but does not describe how the requirements are met.

The guide establishes an updated approach for system classification, with a defined focus on product quality and expanded scope on the product manufacturing lifecycle, and provides criteria to classify systems into two categories:. The guide approach presents a System Risk-Assessment approach to establish and document the Critical Design Elements CDEs of the system design and operation that can impact product quality and identifies the controls design and procedural that mitigate the risks to product quality.

CDE identification replaces the former Component Criticality Assessment that lacked the means to rank the risk of the identified components to impact process control or CPP failure.

The approach recognizes that systems used in pharmaceutical manufacturing are generally well accepted for use in manufacturing and incorporate standard design control elements. The SRA is used to:. The importance of DR and subsequent DQ is described as a continuous process throughout the design process of the manufacturing facility.

Guidance is provided for executing and documenting DR and DQ. It is noted that the DR assures that the deliverables of the design meet the URS requirements and the mitigation control strategies developed during the RA.

DQ is formal documentation to show that critical aspects and CDEs have been included and addressed in the design.

DQ is not intended to be a separate activity from DR but rather is a document focused on critical aspects and is approved by quality. The guide introduces the planning process, an overview of the plan content, identifies what should be included in the plan an what is not in scope, describes how to organize and write the plan.

It outlines the scope and the purpose of the approach to testing, and the roles and responsibilities involved. For manufacturing systems, all planned testing activities, including the integration of mechanical, electrical, and automation control systems components are tested to provide evidence that all acceptance criteria related to user requirements are achieved. Documentation verification and testing demonstrate that a manufacturing system is fit for its intended use and leads to acceptance and release of the system.

The chapter uses Qualification to refer to document verification and testing for quality requirements as determined by the system risk assessment. Commissioning refers to documentation verification and testing for all design requirements as listed within the URS, which may include Qualification testing. Applying GEP leads to a high degree of assurance that the system meets operational requirements while being cost-effective, compliant with regulations, and well documented.

Another key area addressed is discrepancy management. Guidance is given on determining whether these out of specification OOS results are critical or not critical; those being critical require quality approval.

A discrepancy matrix is provided, indicating where quality input is and is not required. Acceptance and Release is where all previously completed testing is formally reviewed and accepted, and operational quality system elements are verified for systems that are qualified to be in place confirming that the equipment is ready to be released for GMP use.

Release may be documented within a Qualification Summary Report, Acceptance and Release Report or through a change control system. After release, site change control replaces engineering change management and the project team transitions system ownership to operations. The acceptance and release process is described along with the organizing and writing of summary reports. Content included in the additional chapters covers:. Visit our page for more info and to access the link to download the full Guide!

Steve Wisniewski. As a principal consultant, he has been involved with the management and direction of several compliance-driven projects and consulting assignments.

Nathan Temple. Nathan Temple is a project manager and license d Professional Engineer with twenty consecutive years of experience in the fields of start-up, maintenance, commissioning, and qualification. He is a certified Project Management Professional. Search this site on Google Search Google. By Category. Systems classified as direct impact provide the focus for the System Risk Assessments. Not direct impact — those systems not having a direct product quality impact.

These systems are commissioned only. System Risk Assessment The guide approach presents a System Risk-Assessment approach to establish and document the Critical Design Elements CDEs of the system design and operation that can impact product quality and identifies the controls design and procedural that mitigate the risks to product quality.

The following details the type of documentation used in the above execution strategy: Documentation Review — Documents, such as vendor testing documents and MOC certificates, that confirm vendor testing has been completed and recorded per previously agreed to GDP practices. Factory and Site Acceptance tests — Vendor testing, with technical oversight to demonstrate that conformance to design and contractual requirements. Test and Balance Reports — Testing conducted with technical oversight to demonstrate that conformance to design and contractual requirements.

Acceptance and Release Acceptance and Release is where all previously completed testing is formally reviewed and accepted, and operational quality system elements are verified for systems that are qualified to be in place confirming that the equipment is ready to be released for GMP use.

Nathan Temple Nathan Temple is a project manager and license d Professional Engineer with twenty consecutive years of experience in the fields of start-up, maintenance, commissioning, and qualification.

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ISPE’s Commissioning and Qualification Guide Second Edition

Recent developments, e. Adjustments to the state of the art were made in the past by means of " bridges ". The new document is very extensive with a total of pages. The Baseline itself contains "only" pages, though.

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ISPE publishes revised Guideline on Commissioning and Qualification

Hello good people of the world! This is volume 5 of the baseline guides. The first edition was first released way back in March , so we should expect this to be a significant revision. Please note this guide is not available for free. It is often the case however that best practices documented in guides become industry standard, and then set expectations for regulators. Hello, waiting to read the new document I find your article interesting. I think the difficult thing is to understand how to perform risk analysis correctly and how to identify the correct frequency of qualification tests.

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Baseline Guide Volume 5: Commissioning and Qualification (Second Edition)

By Steve Wisniewski , July 16, The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment. This guide defined a better understanding of baseline cGMP requirements through coordination with ISPE, industry, and global regulatory bodies. The guide defined a flexible and innovative lifecycle approach to facility, systems and equipment design, construction, commissioning, and qualification supported by the definition of key terms for consistent interpretation and application. Beginning in industry began recognizing the importance of a science and risk-based qualification approach with a focus on Quality by Design that was built around risks to product quality and patient safety.

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