Ispe commissioning and qualification guide pdf free download

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For direct impact systems, GEP is supplemented by enhanced documentation and qualification practices with the active participation of Quality Assurance personnel. The guide also attempts to clarify some misconceptions about how activities are defined, which activities are the subject of regulatory oversight and the sequence, if any, of these activities.

For example, the guide discusses Enhanced Design Review and the components and criteria of this activity. The intent is to identify design aspects that are key to manufacturing facilities regulated by the FDA or other health authorities. How this enhanced design review is accomplished, either with a formal or informal process, is at the discretion of the individual company. The intent is not to establish new administrative requirements, especially for those activities not regulated by FDA or other regulatory authorities.

There are two primary goals of the Commissioning and Qualification Baseline Guide. The first is to bring a common terminology and methodology to the commissioning and qualification process that can be used by manufacturers, facility designers, contractors and equipment suppliers. The second is to provide a system impact assessment process to bring structure and consistency to determining a direct and indirect impact system. An important secondary goal is to foster an interdisciplinary team approach to commissioning and qualification.

Such an approach will help establish an effective basis for master planning and execution of facility projects. Specifically, the Guide is focused upon value added approaches that will eliminate duplication of effort and the costly practices of:.

This Chapter describes the purpose and philosophy of the Commissioning and Qualification Baseline Guide, and the differences between the commissioning and qualification processes in the context of this Guide. It is important to understand and apply the approaches outlined in this Baseline Guide in a sound and well-reasoned manner, since every facility and project is different. V-models are provided for both Direct Impact systems and Indirect Impact systems and the role of Quality Assurance is discussed.

Impact Assessment assists in defining the Commissioning and Qualification scope of a project. This Chapter considers the Impact Assessment process.

Terms specific to Impact Assessment are defined. A method is suggested for defining the steps of a system assessment process, including a discussion of the benefits, and a list of the criteria for determining system impact and component criticality. This Chapter provides an overview of the various project phases and sequence, from inception through commissioning, qualification, and operation.

Overviews are provided of both effective project controls, and project team concepts and organization. Stages in the design process are described with specific consideration of Piping and Instrumentation Diagrams, Specifications, and Construction drawings.

Construction involves several elements, which are crucial to every project, including project site logistics and project quality control. This Chapter details typical requirements and elements of construction.

The information given in the Chapter aims to demonstrate how GEP, as applied throughout the project lifecycle, provides a basis for effective qualification. This Chapter defines the term commissioning in the context of the Guide and describes the organization and content of the Commissioning Plan document. Commissioning is positioned within the context of the Qualification effort and guidance is provided in the management and execution of the commissioning activities.

Typical commissioning deliverables and the associated commissioning team responsibilities are considered. Direct impact systems are subject to qualification practices that incorporate the enhanced review, control and testing against specifications and requirements necessary for compliance with current Good Manufacturing Practice.

The purpose of this chapter is to introduce a high level overview of qualification practices that are required for direct impact systems. This Chapter contains detailed consideration of Enhanced Documentation.

Enhanced Design Review EDR is the term adopted by this guide to describe the process by which engineering designs for pharmaceutical facilities, systems and equipment are evaluated. This process compliments Good Engineering Practice. The EDR process is detailed.

A structured design review method and a failure modes analysis method are suggested for evaluating designs. Installation Qualification IQ is an activity that is regulated by the FDA, and is a part of final qualification activities before process validation begins.

Describe the types of activities that occur and documentation that is needed for the Installation Qualification Process. Describe the types of activities that occur and documentation that is needed for the Operational Qualification Process. Performance Qualification PQ is an activity that is regulated by the FDA, and is the final qualification activity before the remainder of Process Validation begins.

For pharmaceutical grade utilities and certain support systems, PQ is the final qualification step. Describe the types of activities that occur and documentation that is needed for the Performance Qualification Process. This Chapter provides details of those programs that are undertaken to provide assistance and information in support of the qualification activities. Some of these programs can be applied to Direct, Indirect and No Impact systems and their components.

Where these programs are undertaken in support of qualification activities, the appropriate qualification practices must be followed to ensure that the compliance of the over-all qualification effort is not compromised. Related programs considered include:. Terms and concepts used throughout the Commissioning and Qualification Baseline Guide are defined and cross-referenced. The illustrative examples given in this Chapter provide one interpretation of how the key concepts of this guide. Depending upon company policies or the intended use of the equipment listed, there may be additions or deletions to the listed activities.

Match case Limit results 1 per page. Author: lgerardorendon Post on Nov 2. Category: Documents download. Editors Disclaimer: This guide is meant to assist pharmaceutical manufacturers in the design and construction of new facilities that comply with the requirements of the Food and Drug Administration FDA. This Guide was prepared by the ISPE, and has incorporated comments from: Industry representatives from all areas and disciplines FDA Field Investigators and personnel from The Center for Drug Evaluation and Research It is recognized that industry standards evolve and this document reflects the understanding of these standards, as of publication date.

Direct Impact systems are expected to have an impact on product quality Indirect Impact systems are not expected to have an impact on product quality Both types of systems will require commissioning, however, the Direct Impact systems will be subject to supplementary qualification practices to meet the additional regulatory requirements of the FDA and other regulatory authorities. An overview of the Chapter structure is given in Figure The primary objectives of this chapter are to: Provide an overview of the Installation Qualification process Describe the types of activities that occur and documentation that is needed for the Installation Qualification Process Describe how Installation Qualification fits in with the overall qualification process Describe how Commissioning integrates within the Installation Qualification process 9.

The primary objectives of this chapter are to: Provide an overview of the Operational Qualification process Describe the types of activities that occur and documentation that is needed for the Operational Qualification Process Describe how Operational Qualification fits in with the overall qualification process Describe how the commissioning process integrates within Operational Qualification The primary objectives of this chapter are to: Provide an overview of the Performance Qualification process Describe the types of activities that occur and documentation that is needed for the Performance Qualification Process Describe how Performance Qualification fits in with the overall qualification process Describe how the commissioning process integrates within Performance Qualification Prezentare ispe.

All rights reserved. It also gives a brief overview. ISPE Volume 3. ISPE updated. Commissioning and Qualification Verification in The key elements of a validation program should be clearly defined and documented in a validation master plan or equivalent documents.

After completion of a satisfactory qualification, a formal release for the next step in qualification should be made as a written authorization. The first element of the validation of new facilities, systems or equipment could be Design Qualification DQ. The compliance of the design with GMP should be demonstrated and documented.

Installation qualification, operational qualification, and performance qualification are specified and defined as to typical content focus. Other approaches are also possible. Again, it is important to note that to be in conformance with the standard, one does not have the option of picking and choosing which aspects of E to implement on a particular project. A rose, by any other name, is still a rose.

Activities, and the associated documents, should be structured in a manner that constitutes the most effective approach to inspecting and testing each piece of equipment, each system, and associated automation - based on sound engineering practices. If the purpose of qualification was to demonstrate that equipment and systems were fit for their intended use, then one would need to show that the equipment and systems can support manufacture of a particular product using a particular process.

Annex 11 Computerized Systems Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality or quality assurance. Persons should be appropriately trained and have appropriate expertise as applicable to a computerized system.

The extent of validation necessary will depend on the intended use, whether validation is to be prospective or retrospective, and whether or not novel elements are incorporated. ICH Q9 Quality Risk Management [Quality Risk Management can be used] to determine the scope and extent of qualification of facilities, buildings, and production equipment Focus on that which affects product quality.

User requirements, based on the process and not on equipment or systems , are the key to acceptability. Risk assessments, process development, and experimental design are used to identify critical features, functions, and critical process parameters.

All activities must contribute value to the start-up and delivery of manufacturing capacity. Risk-based asset delivery. Different types of equipment and systems custom, off-the-shelf, simple, and complex, etc. Value-added documents.

Documents serve a useful purpose of controlling activities, they ensure completeness, and they serve as a record of what occurred. Only data which serves a useful purpose should be collected. Use of supplier documentation. Test planning. Defined tests should only be carried out once, unless there is a clear justification for undertaking further tests at a later stage of commissioning.

Fostering innovation. Any program must remain flexible enough to apply sound and qualified scientific and engineering judgment based on the situation at hand. Sidebar 2. How can one qualify it? But qualification is not about meeting engineering specifications, it is about being fit for purpose.

Hence, qualification should be tied directly to a particular product manufactured via a particular process. However, project teams must implement a workable system of change management using good engineering practice to ensure changes are noted, appropriate documents updated, and appropriate groups, including QA when warranted, are notified of the change.

There is no requirement for an enhanced turnover package in order to qualify a system. There is an expectation that firms will have accurate drawings and sufficient information to operate, maintain, and change their equipment and systems. A signature by the operations and maintenance managers should be sufficient to signify an acceptable documentation package for these purposes. Other common turnover package contents include records of pre-start-up activities and pre-commissioning inspections and checks.

Having these on hand to support start-up and commissioning is a good engineering practice. Common elements. First, both advocate a life cycle that is based on requirements definition, design and design reviews, inspection and testing, and acceptance. In the case of GAMP, there are categories of automation systems.

Depending on the category, one engages a set of activities designed to assure the robust operation of the system. This categorization and the quality assurance activities associated with each category is, in and of itself, a form of risk management. Less risky off-the-shelf software is subjected to a reduced set of these activities. These and other risk analysis methods have been a part of GAMP for some time.

GAMP categories are one dimension of risk. Other risks assessment dimensions can include: a. The intended use Is the system, feature, or function impacting to product quality? What is the nature and stage of the process? The genesis of the function, feature, or system c. The ability to detect a defect or Out of Specification condition, e. Role of Quality. Documentation practices. Software delivery project controls. GAMP should provide practical guidance that aligns with practices from other industries relative to the control of software projects, such as configuration change management, software test reporting discrepancy management , preliminary and critical design reviews traceability of requirements to design, and the robustness of the logic design , etc.

Software verification. GAMP guidance has been, and should continue to be, invaluable in how to approach verification of these various systems from both a structural and functional perspective. A critical analysis of the most efficient means to verify these systems may challenge the perhaps overly simplistic V-model; especially as complex PAT systems are developed and deployed which adapt a process based on a multitude of input variables. Sidebar 3. The GMPs require nothing more than this.

If we have a more flexible test program, a more robust test program will result. This is especially important when dealing with PAT or other complex, novel technologies. A rose, stripped of its thorns, is still just as beautiful and fragrant.

These documents have been widely accepted and used by industry. This is inefficient, costly, and time-consuming. See Sidebar 3 for a discussion of how these guidance documents might be harmonized. It was desired to both leverage commissioning to streamline qualification, and also to use a risk-based approach to focus qualification. Risk assessments were used to identify the risks to the patient that could result from the manufacturing process. Risk control mechanisms were identified for each risk.

These risk control mechanisms took the form of automation controls, detection mechanisms, design features, procedures, and other means.

The protocols were developed as a checklist of these mechanisms пїЅ the protocol for a bioreactor ran all of 12 pages, with the first six being front matter. A thorough, documented commissioning of the mechanical and automation systems took place as part of start-up. Commissioning included inspections, tests, start-up procedures, setting to work activities, and anything else deemed necessary to bring the system to a fully operational state, verified to be installed and operational per engineering specifications.

Manufacturers and consumers should both win as a result of this standard. ASTM E55 committee is currently working on a number of other standards relating to pharmaceutical manufacturing. The future looks promising! In similar vein, process validation is the confirmation that the overall manufacturing process has been properly designed, monitored, and controlled so that the resulting drug product is of consistently high quality and meets all of its specifications.

About the Authors Robert E. He initiated the effort to develop this standard, and was involved in the ASTM E writing effort throughout its three year process.

Girls School Rd. David E. He is a licensed professional engineer and holds a BS in engineering from Drexel University in Philadelphia, Pennsylvania. Auxilium Pharmaceuticals, Inc. Pre Qualification 2 61 4 4MB Read more. Your name.

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During the production of this guide, regulatory authorities have expressed concern that designating a system Indirect Impact might be a means of doing less than full testing on a system that may actually require it. This is not the intention.

The objective is that through a comprehensive impact assessment process, those systems presenting a risk to product quality are identified and given the attention appropriate to this level of risk, and by the right people e. QA Departments. This places a responsibility upon engineers to communicate clearly the nature of operation of engineering systems, and their potential impact on product quality.

It will also be seen that throughout the Guide, the application of Good Engineering Practice is essential to the commissioning and qualification activities. Good Engineering Practice, commonly referred to as GEP, is proven and accepted, cost-effective, engineering methods and practices that ensure the effective satisfaction of stakeholder requirements. As such, GEP ensures that an engineering project meets the requirements of the user while being cost effective, compliant with regulations and well documented.

Guidance and standards that have been defined by engineering institutes and other learned bodies support GEP. For direct impact systems, GEP is supplemented by enhanced documentation and qualification practices with the active participation of Quality Assurance personnel. The guide also attempts to clarify some misconceptions about how activities are defined, which activities are the subject of regulatory oversight and the sequence, if any, of these activities.

For example, the guide discusses Enhanced Design Review and the components and criteria of this activity. The intent is to identify design aspects that are key to manufacturing facilities regulated by the FDA or other health authorities. How this enhanced design review is accomplished, either with a formal or informal process, is at the discretion of the individual company. The intent is not to establish new administrative requirements, especially for those activities not regulated by FDA or other regulatory authorities.

There are two primary goals of the Commissioning and Qualification Baseline Guide. The first is to bring a common terminology and methodology to the commissioning and qualification process that can be used by manufacturers, facility designers, contractors and equipment suppliers. The second is to provide a system impact assessment process to bring structure and consistency to determining a direct and indirect impact system.

An important secondary goal is to foster an interdisciplinary team approach to commissioning and qualification. Such an approach will help establish an effective basis for master planning and execution of facility projects.

Specifically, the Guide is focused upon value added approaches that will eliminate duplication of effort and the costly practices of:. This Chapter describes the purpose and philosophy of the Commissioning and Qualification Baseline Guide, and the differences between the commissioning and qualification processes in the context of this Guide. It is important to understand and apply the approaches outlined in this Baseline Guide in a sound and well-reasoned manner, since every facility and project is different.

V-models are provided for both Direct Impact systems and Indirect Impact systems and the role of Quality Assurance is discussed. Impact Assessment assists in defining the Commissioning and Qualification scope of a project. This Chapter considers the Impact Assessment process. Terms specific to Impact Assessment are defined.

A method is suggested for defining the steps of a system assessment process, including a discussion of the benefits, and a list of the criteria for determining system impact and component criticality.

This Chapter provides an overview of the various project phases and sequence, from inception through commissioning, qualification, and operation. Overviews are provided of both effective project controls, and project team concepts and organization. Stages in the design process are described with specific consideration of Piping and Instrumentation Diagrams, Specifications, and Construction drawings.

Construction involves several elements, which are crucial to every project, including project site logistics and project quality control. This Chapter details typical requirements and elements of construction. The information given in the Chapter aims to demonstrate how GEP, as applied throughout the project lifecycle, provides a basis for effective qualification. This Chapter defines the term commissioning in the context of the Guide and describes the organization and content of the Commissioning Plan document.

Commissioning is positioned within the context of the Qualification effort and guidance is provided in the management and execution of the commissioning activities.

Typical commissioning deliverables and the associated commissioning team responsibilities are considered. Direct impact systems are subject to qualification practices that incorporate the enhanced review, control and testing against specifications and requirements necessary for compliance with current Good Manufacturing Practice.

The purpose of this chapter is to introduce a high level overview of qualification practices that are required for direct impact systems.

This Chapter contains detailed consideration of Enhanced Documentation. Enhanced Design Review EDR is the term adopted by this guide to describe the process by which engineering designs for pharmaceutical facilities, systems and equipment are evaluated.

This process compliments Good Engineering Practice. The EDR process is detailed. A structured design review method and a failure modes analysis method are suggested for evaluating designs. Installation Qualification IQ is an activity that is regulated by the FDA, and is a part of final qualification activities before process validation begins. Describe the types of activities that occur and documentation that is needed for the Installation Qualification Process.

Describe the types of activities that occur and documentation that is needed for the Operational Qualification Process. Performance Qualification PQ is an activity that is regulated by the FDA, and is the final qualification activity before the remainder of Process Validation begins.

For pharmaceutical grade utilities and certain support systems, PQ is the final qualification step. Describe the types of activities that occur and documentation that is needed for the Performance Qualification Process. This Chapter provides details of those programs that are undertaken to provide assistance and information in support of the qualification activities.

Some of these programs can be applied to Direct, Indirect and No Impact systems and their components. Where these programs are undertaken in support of qualification activities, the appropriate qualification practices must be followed to ensure that the compliance of the over-all qualification effort is not compromised. Related programs considered include:. Terms and concepts used throughout the Commissioning and Qualification Baseline Guide are defined and cross-referenced.

The illustrative examples given in this Chapter provide one interpretation of how the key concepts of this guide. Depending upon company policies or the intended use of the equipment listed, there may be additions or deletions to the listed activities. Match case Limit results 1 per page. Author: lgerardorendon Post on Nov 2. Category: Documents download.

Editors Disclaimer: This guide is meant to assist pharmaceutical manufacturers in the design and construction of new facilities that comply with the requirements of the Food and Drug Administration FDA. This Guide was prepared by the ISPE, and has incorporated comments from: Industry representatives from all areas and disciplines FDA Field Investigators and personnel from The Center for Drug Evaluation and Research It is recognized that industry standards evolve and this document reflects the understanding of these standards, as of publication date.

Direct Impact systems are expected to have an impact on product quality Indirect Impact systems are not expected to have an impact on product quality Both types of systems will require commissioning, however, the Direct Impact systems will be subject to supplementary qualification practices to meet the additional regulatory requirements of the FDA and other regulatory authorities. An overview of the Chapter structure is given in Figure The primary objectives of this chapter are to: Provide an overview of the Installation Qualification process Describe the types of activities that occur and documentation that is needed for the Installation Qualification Process Describe how Installation Qualification fits in with the overall qualification process Describe how Commissioning integrates within the Installation Qualification process 9.

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