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GATHERING VALIDATION DOCUMENTATION FOR PHARMACEUTICAL WATER SYSTEMS By Donald R. Keer, P.E, Esq. Ionics Life Sciences, Inc.

Pure water is one of the most important and most commonly used reagents in the pharmaceutical and biotechnology research laboratories, operations, and production. Purified Water (PW) and Water for Injection (WFI) systems fit neither the traditional definition of a pharmaceutical process nor the traditional definition of a utility. The systems are usually located in mechanical areas, they are distributed throughout the facility, and they are available with all the other utilities, such as compressed air, nitrogen, and chilled water. These characteristics make the high-purity water system look like a utility. The water produced is to become part of a final pharmaceutical product; therefore, it must be validated to standards issued by the United States Pharmacopeial Convention Inc. (USP), and it is subject to Food and Drug Administration (FDA) review. These characteristics make the systems resemble a traditional pharmaceutical process. These combined characteristics can lead to problems that multiply and eventually affect validation. Validation of a water system means compiling documentation that shows that it is installed correctly and operates according to design. The objective of the validation process is to ensure that the system consistently produces water to a predetermined standard and, if it does not, that there are sufficient warnings and procedures so that the final product is not adulterated. Ultimately, validation determines the success of the project. Most operational problems can be addressed during design or at start-up. Thereafter the largest problem is the gathering of the documentation. The FDA inspectors want certain documentation that verifies the system's validation and assembly. Validation begins when the project starts. If the validation is conducted and integrated properly, the number of surprises during the execution of the protocols is reduced and all documentation is available when the process is complete. There are six steps to integrating validation into a water system project process: 1. Review of design parameters and alternatives 2. Design and engineering 3. Off-site assembly of components 4. On-site installation 5. Preparation and execution of validation documents and performance protocols 6. Ongoing support (1) Certain documents are produced at each step of the project and either be- come part of the final validation package, are integrated into other documents, or influence the production of the final documents. The more traditional labels used in the design process are "Basis of Design," "Conceptual Design," "Detailed Design," "Construction," and "Validation." These phases of the project can be discussed as separate entities but the lines between them can be left undefined. The overall project benefits when the team members are included in each phase. A typical water system project team should consist of the operators, design team, corporate m anagement, validation personnel, equipment and installation contractors, and the construction manager. Operators include the plant personnel (hereafter referred to as operations) who will operate and maintain the system. The design team is a combination of internal and external engineers and designers who have the

responsibility for documenting the construction and installation of the system. Corporate management includes traditional managerial functions such as finance, human resources, safety, environmental, and operations management. Validation is the group that will produce and execute the protocols. Validation may be composed of internal personnel, external personnel, or a combination of the two. The equipment and installation contractors are the companies that will actually supply and install all the equipment, pipe, instrumentation, and other items. The construction manager will supervise the actual installation as the owner's representative. Each team member contributes information to the preparation of the documentation, though certain team members should take the lead for certain parts of it. The designer and the validation group must have enough experience and background in pharmaceutical water systems to guide the project documentation. The key to success here is to identify who takes responsibility for producing documentation and at what point it is produced. A summary of proposed documentation responsibilities throughout an integrated water system project is presented in Tables A and 8, which list the categories and subcategories for a successful project through the PI&D stage. These tables also list the team members who will provide the major support and review in the effort. The tables of responsibilities should be used as a guide to planning the project and the validation effort. Validation requirements vary from company to company and from facility to facility. The documents listed in this series are standard for validation requirements, however, and should be produced in some form on every project. The team members who produce the documents can also vary, depending on the team's strengths and weaknesses. Basis-of-Design Documentation. The Basis of Design is the most important document prepared during the project. This document establishes the scope and sets the direction for further design. A thorough investigation and exchange of ideas is critical to a successful project. The basic design assumptions are also established. These design assumptions affect the technology chosen and the operation of the system. Food and Drug Administration inspectors will be interested in these assumptions, which should be documented as part of the final validation package. The Raw Water sample is obtained by operations. The design team may provide a list of specific ions, substances, microbials, and other properties for which to test. A single sample is insufficient to complete a proper design. The quality of the raw water can change as the seasons change and various contaminants enter the source. If local annual samples are unavailable, then the local utility samples may be used. These samples are not as accurate as samples taken at the source, but assumptions can be made to estimate changes in the contaminants. The water samples should be maintained as part of the validation package. The USP monographs for pharmaceutical waters require that they be produced from raw water meeting the U.S. Environmental Protection Agency (EPA) guidelines for drinking water. Raw water samples should be taken on a periodic, ongoing basis during the duration of the project and the life of the system. Product Water Quality. The quality of water required at the point of use is determined by operations. Validation and the designer may also have input to the decision. The product quality requirement will drive the entire process design phase. If the product water must be sterile at the point of use, then the design will proceed in one direction; if the product is sensitive to heavy metals, the design may proceed in another direction. The water quality is usually determined by corporate standards that exceed the monograph requirements. The standard should include action limits and failure limits. Facility Operation. The daily and weekly hours of operation of the facility determine the size of the storage capacity and the pretreatment system, and also the method of

sanitization. This information is usually provided by operations, with guidance provided by the designer. Stagnant water is subject to microbial growth. Ideally the sto rage capacity is such that the pretreatment system runs 20 to 24 hours a day. The pretreatment system operators must have an opportunity to regenerate, sanitize, clean, and/or backwash each unit. These operations take time and they must be included in the schedule. If the system is subject to extended periods of low or no flow, then certain design features, such as recirculation, must be included. The inspector will look at the plant and system operations to decide if any design features are missing. Quantity. The instantaneous demand and duration of demand at each point of use must be determined. This information is necessary to size the distribution system and circulating pumps properly. Operations should supply this information, but occasionally it is indeterminant. They may know the overall water consumption but be unsure of the instantaneous demands. The designer can assist in this study by spending time in the facility, by observing operations, or by contacting equipment manufacturers. This information is combined with the diversity and pressure/temperature requirements to size the distribution loop, storage, and makeup. The validation of the system will depend on this information, so it should be included in the final documentation package. Diversity. Besides the maximum instantaneous demand, it is critical also to know the frequency of demand. Diversity provides the maximum number of points of use that instantaneously demand water. In its simplest form, diversity is merely a percentage of the number of point demands open at once. The operation can be simulated using computer programs to obtain a better approximation of the facility operation. This information should be provided by operations, but it is rarely available. The designer must be prepared to spend time in the facility to determine the timing of water demands. The better the information at this point, the more economical the storage, distribution, and pre- treatment design. The diversified maximum instantaneous system demand can be critical if the return flow velocity is used to control biofilm on the pipe. Pressure and Temperature Requirements at the point of use affect the system design and operation. A hot system is usually preferred from a microbial control viewpoint over periodic heat sanitization or ozonation. Points of use with similar temperature requirements should be placed on their own subloop. If only one or two points require "cold" water, then a point-of-use heat exchanger may be more economical. The temperature and pressure required are determined by equipment or product requirements; therefore, the operation of the water system can affect the product quality. Operations should have this information readily available, but the designer should follow up with the equipment manufacturers. This information is part of the final validation execution and will be part of the final documentation package. Microbial Control by some method is necessary in every water system. The method must be compatible with the corporate philosophy and production requirements. Some corporations are more conservative than others; and they may opt for a hot, continuously circulating system over some other options. The designer should determine whether continuous heat, periodic heat, ozone, or chemicals will be the most appropriate sanitization procedure. To maintain microbial control, the procedure must be performed in every vessel and component of the system. The method of microbial control, which can affect materials, operations, and maintenance, is implicit in the design requirements and the operating procedures. The implicit means of control should be stated explicitly for the validation package. Purification Technology. The designer should evaluate and make recommendations concerning the purification t chnology to be used. The final purification step in PW e systems can be a combination of deionization, membrane filtration, microfiltration, and distillation. The WFI production is required by the USP monograph to be reverse osmosis or distillation. The final treatment technology determines the other equipment

required for pretreatment. When evaluating the purification options, the designer should consider the expertise of operations personnel. An unusual technology will be subject to a higher scrutiny by an inspector. If the operating-cost differential is large enough, the additional validation and documentation costs can be justified. Operations and validation should pro- vide input to ensure that the technology chosen is consistent and acceptable. Monitoring Requirements during validation and thereafter should be established up front by the validation group. There should be an intensive schedule of sample points during the first month, slowly reduced in frequency over the course of a year to the final monitoring program. The corporation may have standard requirements that must be included. The designer will use this information to ensure that adequate sample ports are available. The information is also used to highlight additional purity requirements or tests beyond those required by the USP. Documentation required for validation. The validation group should present a list of the documents it expects to be produced during all the subsequent phases of the project. Many are discussed below. To avoid a deficiency at the end of the project, any requirements unique to the company must be brought to the attention of the team. The document list can be used as a checklist to assign responsibilities to the team members to ensure the proper production of the documentation, and can also become the basis for a table of contents in the final package. Design Codes and standards do not immediately seem like a validation document; however, they do establish validation issues such as materials, the means of certifying materials, and installation requirements. National standards should be identified for material quality; welding and joining; installation; and safety, environmental, and electrical concerns. The corporation should identify the design codes applicable to the project. If they are unsure, the designer should have the experience to make recommendations. If the validation group desires, they may include the list in the final package. Current Good Manufacturing Practices (CGMP) are the cornerstone of water syste m design. They are a vague set of guidelines, often subject to individual interpretation. Ultimately the only interpretation that counts is that of the inspector. The FDA publishes a "Guide to Inspections of Pharmaceutical Water Systems." This booklet should be obtained and incorporated into the design. Validation has the responsibility of presenting these interpretations and providing input to areas that continue to be unclear. The designer must have a firm understanding of the standards and practices and have the ability to incorporate them into the design. Some of the cGMPs are clear and straightforward; others are subject to interpretation. If a decision is made that does not strictly adhere to the guidelines. It is imperative that the assumptions and reasoning for the decision are documented. Budget. The project budget is used by the corporation to track the project's financial status. Budgets are developed early with accuracies of :1:25%, which can be narrowed to +/-10% once the conceptual design is complete. The budget is not a validation document, but it can affect design choices and validation and should include the cost of documentation. A sound system design is worthless without the proper documentation, and preparing the documents costs money. Schedule, similar to budget, is used to track the project's progress. In many instances the end date is established and all other activities are coordinated to meet that date. The schedule is not a validation document, but document preparation and protocol execution must be incorporated into the schedule. The overall schedule for the project is determined by corporate management. It should be realistic, not forcing shortcuts in documentation preparation.

Environmental and Safety Concerns. Environmental and safety concerns are high on the list of concerns at all companies, and should be highlighted by the corporation and operations. The designer will bring experience to the team and should make recommendations where applicable. Water systems can involve extensive chemical handling and generate large quantities of wastewater. The designer should know any effluent limitations that exist for the facility, and all the applicable corporate safety standards. The water system can contain high-temperature water or even clean steam, and a release would place employees in danger of serious burns. The final design will be impacted by the choices made in these areas, and the validation documents will ultimately reflect those decisions. Control Philosophy. Plants are increasing the amount of automation in their facilities. The degree of monitoring, controls, and automation theoretically increases the capital cost of a project while reducing operating cost. One of the major capital costs is software validation. The degree of complexity should be consistent with overall plant automation, or with planned upgrades in plant automation. Operations and corporate management know the plans for the facility, and this information must be communicated to the designer and to validation personnel. Software design can increase the over- all design cost by as much as 20% and the validation costs much as 50%. The validation cost impact can be greatly reduced by documenting software immediately. The designer and programmer should use consistent nomenclature to aid the validation process. The programmer must understand the validation process, or else the software documentation will be inadequate. The control philosophy will be part of the final validation package. Summary of the Basis-of-Design Documentation. The information gathered during the basis-of-design phase should be compiled into a single document that is reviewed and approved by the entire team. This document is carried forward as the project progresses and is used as a measuring stick for all further actions. The benefits of a clear and comprehensive basis of design are that the cost estimates will not drift, the designer can proceed quickly with minimal rework, and validation personnel can proceed with preparing protocols. This integrated approach reduces validation time required at the end of the project, and the other team members know what to expect. Conceptual Design Documentation. Conceptual design is the process of developing and evaluating various scenarios that meet the design requirements established during the basis-of-design phase. The end result is a set of documents that becomes the skeleton of the project. The latter stages of the project add flesh to the skeleton, building upon the chosen concept. The concept is important to obtaining proper documentation. During this phase, a process flow diagram, a general sequence of operation, and a layout are developed. Documenting choices made to overcome various obstacles can help to answer questions from an inspector and to explain design choices. The final concept documents will all impact validation. PFD/Preliminary P&ID The process flow diagram (PFD) and the process and instrumentation diagrams (P&IDs) define the process schematically. The designer should prepare both documents. The PFD is useful in preliminary discussions and conceptual designs. It becomes the basis for the rest of the process design. As the design is developed, the PFD evolves into a P&ID. The P&ID should identify all major equipment, along with the on-line monitoring, sample points, and control hierarchy. It should provide enough information to clearly describe the system for the validation group. The preliminary P&ID is completed, pending changes required by construction or vendor modifications. It is a control document that is used to track the system design. Validation will use the document during installation qualification (IQ), operation qualification (OQ), and process qualification (PQ).

General Sequence Of Operation. The designer should develop a general sequence of operation (SOO) for the sys - tem described in the PFD. The sequence describes how the system is intended to operate. Validation can use this information to initiate the protocols; operations should ensure that the operation of the system is consistent with the other systems within the facility. The sequence should detail all the operations the system must perform, including start-up, shutdown, sanitization, backflushing, alarm conditions, alarm response, and emergency shutdown procedures. A detailed valve sequence is not necessary at this point, but flowrates and the durations and frequency of procedures should be included. This general sequence is used as a measuring stick for final operations and software development. The document is included in the final validation package. Symbols and Abbreviations. Consistency in documentation is important, and makes it easier for the FDA to evaluate the documentation as a whole. All drawings and documentation should use the same symbols and abbreviations, compiled by the designer and based on corporate standards and/or the operating standards where the system is to be installed. The symbols sheet should be developed early and supplied to all groups. The symbols and abbreviations are part of the final validation package. Calibration Requirements. All measuring instruments must be calibrated for accuracy. The initial calibration may be performed in-house by the validation group or by the instrument supplier. If the contractor is to perform the initial calibration, the validation requirements must be supplied in the request for bid. The record of calibration is made a part of the OQ. The calibration method should be the same procedure that validation plans to use after installation. Mechanical Space Limitations. Equipment occupies space. Mechanical space limitations will impact the technology decisions and other design choices. Operations can identify the space, and the designer and construction manager may provide input as to cost impacts and options when evaluating the possibilities. If the new system is to occupy a space currently occupied by existing water equipment a plan must be developed to phase in the construction and start-up. The choice of space may be impacted by budget, production or zoning requirements. The final space limitation will be reflected in the equipment arrangements and in the choice of technologies. Documentation Submittals. If the contractor is to be involved in the validation effort, the documentation to be submitted must be clearly established in the conceptual phase. Validation should formalize the document requirements to be provided by the contractors. It is validation group's responsibility to track the document preparation and final submittal. A specific example of a document that should be produced by the contractor is the final pipe routing for the pretreatment skids. The designer should give copies of the document presentation standards (symbols and abbreviations) to the suppliers and contractors so all the documents are consistent. The supplier may also provide final as-builts of pipe isometrics, control panel layout, wiring diagrams, standard operating procedure, data sheets, cleaning and passivation procedures, control software, and manuals. These documents will be used at various places in the validation effort. The designer must not completely abdicate all responsibilities to the contractors. The designer's expertise and project knowledge must be used to guide the contractors and to answer all questions. Weld Inspection Requirements. The weld inspection requirements can greatly increase the cost of installation; therefore, they must be clearly established prior to installation. The welds may be visually inspected with a boroscope, they may be videotaped, or they may be radiographed. The costs can vary dramatically between the options. Validation develops the requirements based on operation's standards. If no standards exist, all parties can work together to determine the weld documentation desired. If the system is maintained at 80oC or is sanitized daily and the products are not susceptible to bacteria contamination, the weld documentation may become less

critical. The most conservative approach is to boroscope and videotape each weld and then file the videotape with the other validation documentation. With departure from hot operation, the weld information becomes more critical. The final standard must be in the bid documents for accurate bids. Installation Requirements. Installation requirements include storage and handling, material tracking, layout and fit-up, erection, flushing, testing, cleaning, and passivation. Documenting installation ensures traceability of materials, compliance with conceptual documents, and cleanliness of wetted surfaces. Validation and design should develop the standards for the contractor to follow. The construction manager can supply input to the process. After installation, the contractor must certify that the procedures were followed. That certification becomes part of the IQ package. Construction Plan. Coordination of validation with construction can minimize the validation effort after construction. The construction manager should establish a construction plan that coordinates all involved parties. An outline of the plan is included in the bid package to assist the supplier in pricing the system and planning its execution. Validation can use this information to plan out the execution of the protocols. With proper planning, the 10 and 00 may be finished at mechanical completion and the PO initiated during start-up. The earlier the construction plan can be developed, the sooner potential problems are highlighted. Approved Vendors. There are no contractors who manufacture all their own pipe, instruments, electronics, and vessels, among other items. Approved vendors for all critical items should be included with the request for bid to the contractor. Operations are in the best position to ensure that the approved vendors are consistent with the usage in the rest of the facility. The designer can provide guidance where no preference exists for a particular vendor. The designer should also review existing preferences for state-of-the-art and CGMP compliance. Validation should also review the vendors for approval. The final list should be included in the bid package and final documentation package. During 10, validation will confirm that all items are manufactured by the approved vendors. Bid Package Division. The number of bid packages for water systems can vary from one to dozens, depending on the project approach. To avoid confusion during start-up, the number of contractors involved is usually no more than three: pretreatment, distribution, and controls. In some cases the three suppliers may have certain equipment excluded from their scope (such as tanks, pumps, or heat exchangers). If operations or corporate management desire a performance guarantee, a single contractor should be chosen. The way the bid packages are distributed affects the way the detailed specifications are developed. If there are many small bid packages, the specifications must be written for easy division. If a few large bids are to be sought, then the specifications can be consolidated into several large packages. The specifications developed by the designer must be consistent between packages. The division of bid packages also affects validation documentation by determining the extent to which contractors may be incorporated into the validation effort. Use of many individual suppliers shifts the responsibility of compiling documentation from the contractor to the validation group. Control Philosophy/Hierarchy. There is a tremendous span of control sophistication, from a system that contains manual valves and basic alarms and monitors, to a system that can be completely automated with a personal computer (PC) interface. Operations must determine the degree of automation desired, based on the incremental cost and on the skills of the operators who will be running the system. Validation should also provide input. Software validation can triple the cost of validating the system, especially if the programmer is not familiar with the software documentation requirements of the validation process. Once the control philosophy is determined, the designer must include a detailed description of it in the specifications. This will head off attempts by suppliers to reduce their cost of the system construction by using controls that are

inconsistent with the overall scheme. An example is the use of a standalone temperature control valve on the regeneration skid to heat caustic when a complete programmable logic controller (PLC) control scheme is desired. The controI hierarchy must also be established at this point in time. A basic set of control precedents and overrides helps the supplier to understand the system control objectives. If controls are divided into a separate bid package, the hierarchy must also be explained to the suppliers of noncontrol processes and equipment. The control philosophy and hierarchy become part of the IQ as it relates to the software validation. General Equipment Layout. The designer should evaluate the mechanical space limitations discussed above and develop a general equipment arrangement. Operations should have significant input. The objectives are to be general enough to permit all the acceptable vendors to bid on the project and to confirm the equipment sizes. The layout must be detailed enough, however, to allow for planning of material and personnel flows, pipe runs, and access to equipment, safety, and egress. Validation will use the drawing to prepare part of the IQ. General Pipe Routing. The space necessary to add the distribution pipe is as critical as the mechanical space. The designer must spend enough time onsite and with operations to develop a routing scheme. The routing plan should identity slopes, lowpoint drains, and high-point vents. The routing plan is not final, however. Changes are usually made by the supplier in the field. The plan must be definitive enough to permit competitive bidding, but should not result in change orders. The general pipe routing is an evolving document that becomes part of the final validation package as the as-built pipe plan. Materials of Construction. The corrosive/solvent nature of h igh-purity water and its ability to support microbes makes the materials of construction very important to certain steel will corrode and certain plastics will emit contaminants. Bacteria can grow in rough surfaces or crevices. The designer should advise and work together with the validation group, corporate management, and operations to establish the appropriate materials of construction. The specification should include distribution pipe material and finish, pretreatment pipe, valves, vessels, instrumentation elements, tanks, and gaskets. All components of the system must have the material requirements defined. The designer should consider the system operation when recommending materials. The material specification should be incorporated into the IQ as checklist items. Cost Estimate. A cost estimate at this time does more than confirm the estimate developed earlier. A +/-10% cost estimate should be developed at the end of the conceptual design. This process will confirm that the technology chosen is appropriate, given the original budget. Any changes in the scope of the project over the original basis of design will also be highlighted. The designer should have the ability to put the estimate together. The cost estimate does not directly result in a validation document, but it should be retained to track the project. A cost estimate that deviates significantly from the original done during the basis-ofdesign phase is an indication that the basis of design does not accurately represent the current project assumptions. The conceptual design should be reevaluated or the basis of design updated. If the basis of design is updated, then an explanation for the changes must be included. Calculations. The designer's calculations for flowrates, pressure relief valves, pumps, regenerations, and pressure drops should be submitted for the record. The calculations will document the equipment design and the parameters they were designed to. Validation uses this information to confirm information used for the OQ. Calculations should be updated as the design is refined. Location of Sample Ports. The validation group should review the conceptual design and approve the location of the sample ports for their monitoring program. The designer

can locate sample ports before and after each piece of equipment in anticipation of validation's requirements. Operation and the corporation may also have standards for sample port placement. There maybe a tendency to over design the sample ports. During validation, each port must be monitored - the more ports, the greater the cost. Each port should be evaluated to ensure that valuable data is obtained. A layout showing sample port numbering and location is part of the final validation documents. Design Review and Approval. The entire conceptual design should be reviewed by the corporation and operations. All comments should be returned to the designer, who should be prepared to meet with all the reviewers to consolidate and align the comments. The comments should be final to allow the designer to proceed with minimal reworking. The final approval is documented to show the inspector that the design was reviewed and accepted by the system's owners. Detailed Design Documentation. The detailed design documents (Table A) define the system according to the standards established in the Basis of Design and the Conceptual Design. The documents may be created prior to choosing the final contractors, but the potential bidders should be consulted to ensure that the design is not proprietary and the skids are properly depicted in the materials. The Food and Drug Administration (FDA) will expect detailed documents to be part of the validation documentation. Once produced, they become living documents that must be updated with each system modification. The documents evolve from the designer's initial package as it goes to the supplier, to the construction manager, to the validation group, and finally to the operations group. In most cases, the designer produces the design documents, then the contractor and construction manager update them based on field conditions, and finally the operations and validation groups maintain the documents as an accurate representation of the system. The documents produced during this Detailed Design phase are used by validation to produce their protocols and records. The importance of this information can be lost on a contractor who is not familiar with the pharmaceutical industry. The supplier may supply much of the final documentation data, but the designer is in the best position to revise existing documents to ensure conformity. The Process and Instrumentation Diagram (P&ID) is one of the key documents an FDA inspector is going to look for. It must be clear, concise, and an accurate reflection of the as-built condition. The designer normally creates this drawing during the Conceptual Design phase, and maintains it during the evolution of the project. The supplier reviews the P&ID during the bidding process. Symbols and abbreviations should be consistent with those used by the designer for the rest of the project. The level of detail, interlock schedules, programmable logic controller (PLC) software controls, and operating logic should be consistent throughout the project and between P&ID versions. The detail and consistency concerns are alleviated if the designer updates the P&ID, based on the supplier's input, after the bidding process. The P&ID becomes a main document in the validation file. It is used during installation qualification (IQ), operation qualification (OQ), and process qualification (PQ) as a map of the system and its interconnections. The P&ID will be used during 10 to check the equipment installation and pipe routing. During the OQ, the equipment operating parameters and operation may be checked. Duri ng PQ, the sample port numbering and location are obtained from the P&ID. Instrument Loop Diagrams are the pictorial representation of the internal system controls. The FDA inspector will want to see these drawings to determine if the controls are operating properly. The designer should provide the initial diagrams to the contractor during the competitive bidding. These diagrams must be accurate enough to permit accurate bids and to avoid change orders later in the project. The contractor is in a better position than the designer to document the instrument wiring in the as-built condition. The contractor's loop diagrams should be consistent with those from the

designer. The diagrams will be used during the IQ to check electric connections, and during OQ for instrument and control valve operation. Equipment Data Sheets are spreadsheet representations of the equipment. They do not replace the specification; rather, they supplement its text. The data sheets should be provided by the designer, though the contractor can provide vendor specific entries. These data sheets are used during execution of both the IQ and OQ protocols. Instrument Data Sheets are similar to the equipment data sheets. They supplement the specification and should be initiated by the designer. The vendor specific entries are made by the contractor. The data sheets are used during the execution of the IQ and OQ protocols. Control Panel Face Layout. The control panel face is the place where the operator interfaces with the system. The designer should develop the layout. Alarms and indicators should be grouped logically and clearly labeled. The designer should provide the preliminary documents to the contractor during the competitive bidding. Once again, the contractor is in the best position to document the final as-built conditions. The control panel layout shows that all the alarms, readouts, and operator interfaces required by the P&ID exist. The layout is part of the IQ package. Control Screen Presentations. Increasingly, personal computer (PC) interfaces are used to operate water systems. If a control screen is used to depict the system, then the screens must be designed. The level of detail depends upon the level of monitoring and sophistication desired. The designer should provide the screen designs to the contractor during the bidding process. For an accurate bid proposal, screens must be identified in the bid documents. The contractor should incorporate the graphics into the software package. The final screen presentations are validated to ensure that they accurately represent the system conditions. Sequence of Operation. The system operation must be documented in the sequence of operation (SOO). The SOO should be prepared by the designer, and accompany the P&ID during bidding. The contractor must adjust the SOO based on the specifics of the skids. The final SOO must be detailed enough to provide exact procedures for responses to alarm conditions, sanitization, backwashing, regeneration, and other processes. The SOO should include a valve chart for clarity, and text to explain the operation. This document is critical to the programming of the PLC. The SOO will also appear in the operations manuals, will be used to train operators, and is used during the 00 of both the equipment and the software. The validation group will incorporate the SOO into the standard operating procedure (SOP), which is a major validation document. Pipe-Routing Plans show how the pipe is routed through the facility. They include the necessary details to define the system. To obtain competitive bids, the designer's drawings must be clear, concise, and accurate. The designer's distribution-pipe layout should be in essence the final routing plan. Occasionally, field conditions will force a change in pipe routi ng by the contractor, who is then responsible for documenting these field changes by either revising the drawings or by marking a set of construction drawings for the designer to revise. The designer can show the general routing of the interconnecting pipe between the pretreatment skids. It is the responsibility of the contractor to develop the detailed construction drawings for the skids based on the designer's specifications. The contractor's plans for the pretreatment pipe are as important as those for the distribution pipe. The same level of detail is required. The actual construction drawings become the validation documentation of the skid assembly. Therefore, the contractor must use consistent documentation symbols and abbreviations.

Pipe Isometrics. The FDA will expect an isometric representation of the distributionpipe routing. The main objective is to show a three-dimensional representation of the slopes, vent points, and points of use. The isometric plan is strongly recommended because of the way it illustrates the system. The low points should be displayed with drain valves. Weld locations must be called out with the weld number (which should be obtained from operations.) All slopes throughout the system must be shown. The isometrics around certain equipment, such as heat exchangers, may be better shown as a separate detail. The designer should produce the initial isometric. The contractor should use the designer's isometric to make field corrections and to locate and number welds. Skid Pipe Arrangements for the pre-treatment equipment are generally unique to the contractor, who should provide the as-built pipe assembly of the skids. These drawings are the detailed construction drawings that are maintained and updated during assembly. The designer and operations should review the drawings and physical assembly for agreement prior to shipment. Validation will use these drawings during the IQ. Junction Box Wiring. The junction box wiring drawings document the hardwired portion of the control system. This information is necessary to document the wiring in the local panels. These drawings are used to check the control's installation. The contractor should supply the as-built drawings based on the designer's bid drawings. Where possible, the designer and operations should inspect the drawings and assembly to verity their accuracy prior to shipment to the site Construction Plan. Installation, start-up and validation are critical to the timely completion of the project. The contractor must present a plan to merge activities with the construction managers. The construction manager, contractor, and the validation group must coordinate activities to smoothly complete the project with all the proper documentation. The water system is a major validated system that can affect an entire facility. A detailed plan can ensure that all construction and validation is coordinated. The plan may not be considered a validation document, but the validation group will develop, based on this information, a schedule that is included in the final documentation of the system. Instrument/Equipment/Valve Tag Numbers. All instrument, valves, and equipment should have unique tag numbers that are used in the documentation, procedures, drawings, installation, and protocols. These tag numbers, required for the validation effort, should be supplied by operations. Coordination is necessary by the designer, contractor, and validation to ensure that all the tags are consistent and correct. The Instrument List is a quick-check index that the FDA inspector can use to spotcheck the instrument installations. The list must be complete, and must contain the tag number, reference P&ID number, the equipment or line number where installed, fluid measurernent, pressure, temperature, manufacturer and model number, wetted materials, specification number, range, set point, zero, span, and loop drawing. The basic form and the preliminary information can be supplied by the designer, but the final list should be completed by the supplier. The final validation package will contain this list that will be used during IQ. Pressure-Test Procedure. The entire system must be pressure-tested to ensure that no leaks occur. The pressure test is required by the American Society for Mechanical Engineers (ASME) code, but there is also a validation reason for obtaining the documentation. Leaks offer an opportunity for back-contamination into the system. The designer should provide the test criteria to the contractor. The contractor must develop and document a procedure to ensure that all portions of the system are tested in accordance with that criteria. The procedure should be reviewed by the designer prior to implementation. The certification of the test results should be added to the IQ file.

Flushing and Cleaning Procedure. Installation of a water system is a dirty operation. All pipe and equipment must be cleaned and flushed prior to putting the system into use. The designer should set the flushing and cleaning criteria, velocities, and chemicals to be used. The contractor should provide the final procedure description to ensure that all portions of the system are tested in accordance with the criteria. The procedure should be reviewed by the designer prior to implementation. The contractor should submit a certification that all wetted surfaces were cleaned and flushed. Passivation Procedure. Passivation is an acidic treatment of stainless steel that reduces its chemical activity when the steel is exposed to high-purity water. All stainless steel surfaces exposed to high-purity water should be passivated to avoid corrosion. The designer provides the criteria for chemicals and flushing, and the contractor develops the final procedure to ensure that each section of pipe is adequately passivated. Once again, the procedure should be reviewed by the designer prior to implementation, and the contractor should certify that the procedure was followed. This procedure is unnecessary if plastic pipe systems are used. Sanitization/Sterilization Procedure. All wetted surfaces will require periodic sanitization or sterilization during the system's lifetime. Sterilization is accomplished by using clean steam throughout the water system. Sanitization may be accomplished in a variety of means, as discussed below. The pretreatment components must also be sanitized. The frequency may only be estimated during the initial phases of the project, but the procedure for accomplishing it can be developed early. The designer documents the procedure through the P&ID and SOO. The contractor develops the arrangement of skids and installs the distribution loop so that the procedures may be carried out. The procedure for sanitization should ensure that all wetted surfaces are exposed to some microbe-limiting action such as a chemical or heat. The chemical can be chlorine, bromine, or ozone. Heat should be a minimum 160oF if the exposure is continuous and there is ample control of microbes in the feedwater system; otherwise a temperature of 18O"F for a minimum of 1 hour is required. The procedures for sterilization are necessary for "sterile" waters such as Water for Injection (WFI) or sterile Purified Water (PW). If the system must be sterilized, clean steam must be available. The frequency is determined during the PO. Software Documentation. As control systems have advanced, so has the complexity of validation. The software used for the controls and monitoring must be documented. Software validation can be the most difficult portion of the validation process. If the validation group can obtain information early, they can start preparing for the execution effort. The contractor's programmer must thoroughly document the system. The more detailed the documentation, the easier the validation effort will be. The logic of the program can be checked by the designer. The final software documentation is maintained in the system file, and must be updated with all system changes. Detailed Specifications. The best way to obtain a competitive bid for the desired design and documentation from a contractor is through a detailed specification. The request for bid should contain a detailed specification that addresses each area where the contractor will be held accountable. A detailed specification is important because it contains a summary of the system concept, documentation requirements, approved vendors, and materials of construction. This document can have more of an influence on the competitive bidding process than do the drawings, as it places all bidders on a level playing field. The specification should summarize many of the decisions made during the Basis of Design and Conceptual Design phases. It is not unusual for the specification to be more than 100 pages. Validation can check this document against the responsibilities checklist developed during the Basis of Design phase and thereby track the production of documentation. Approval of Specifications. The specifications and requirements detailed above should be formally approved prior to incorporating them into the validation package. The

corporation must take ownership of the design at some time. As the detailed documents are completed, they should be reviewed and approved. Input from validation and operations are necessary to ensure that the specifications are consistent with corporate standards and that they request the proper documents from the vendors. Validation will place copies into the system files. Bid-review Report. If the request for bid documents is thorough and document requirements are clearly detailed, then the bid analysis is easy. When bids are submitted, the contractors may make suggestions or may take exception to some portion of the request. Technical exceptions must be reviewed by all internal parties to determine the acceptability of the exception. If the contractor is awarded the bid and the exceptions permitted, then the documentation already produced must be revised. The review report should be written by the designer, for review by validation, operations, and the corporate group management. The technical merit of the bids should be compared, and a contractor recommended. The analysis should include an evaluation of the contractor's experience at producing documentation for validation. The bid review report becomes a miscellaneous validation document that justifies the revision of earlier documents. Construction Documentation Construction is the implementation phase of the project. The documentation produced during construction provides the evidence that the system is installed as designed. Progress inspections and equipment installation are just part of the documentation process during this phase. The essential purpose of the documentation is to ensure that the equipment meets the specifications, conceptual design, and the detailed documents prior to shipment, and is then installed properly. Deviations must be accounted for, documented, and explained. The documents produced during this phase are the material certifications, certifications that commissioning procedures were followed, data on the installed conditions, and final as-built documents. Progress Inspections In addition to the construction manager, the progress of the construction at the facility should be monitored by the owner, equipment supplier and the designer. The equipment supplier should be actively involved in the preliminary testing and documentation of their system as well as the installation and start-up of the equipment. Prior to shipping, the pretreatment system and other equipment should be inspected by the owner or owner's representative to ensure that it meets specifications and operates properly. Corrections in the field can be expensive and time-consuming. In addition to inspecting the equipment, the owner should review the documentation. The equipment supplier should have certifications for the materials of construction, calibrations, pressure tests, cleaning, and (when appropriate) passivation. The inspections should be documented to verify compliance with the specifications, procedures, and conceptual design. In essence, the individual inspecting the equipment has done part of the validation during the early phases of assembly and construction. Shop Drawings should be required for each major piece of equipment in the system. Shop drawings are the first step in ensuring compliance with the design drawings and specifications. The drawings should be marked up for corrections where noncompliances occur, then returned to the equipment supplier. Copies of the original submittals should be kept as a record. Based on the extent of the comments, the drawings may be approved, approved with the changes, or required to be resubmitted. The shop drawings become part of the final validation package, so they must accurately represent the construction of the equipment. This requirement means that the drawings are updated if any changes occur during construction. If changes do occur, they must be documented and approved prior to implementation. Specification/Drawing Compliance Report. All equipment manufactured off- site should be reviewed to ensure that it complies with the specifications and drawings. The specification/drawing compliance report can be combined with the operation test report

(discussed in an upcoming section of the article). This report is also a precursor to the actual validation process. Corrections can be made at the equipment supplier's shop, where the cost is much less than in the field. In essence, the designer is performing a pre-validation review. Any points that require repair or rework should be documented. This documentation will be needed if the changes result in deviations from the design documents. The system is actually subject to two IQ's and two OQ's. The double performance of these protocols should be documented to provide a degree of certainty and thoroughness. The report is filed with the rest of the validation documents. System Preparation Reports. The pressure testing, flushing, cleaning, and passivation of preassembled equipment should be witnessed by the designer, and a report written to document the results of all activities. The supplier should develop a procedure to test and to clean the system. The designer should review the procedures to ensure that they meet the specifications. If there are deviations, they must be documented and explained. The report becomes part of the IQ to document that the wetted surfaces were properly prepared prior to start-up of the system. It also provides independent confirmation of the supplier's certification. Operation Test Report. The operation test report is a precursor to the operation qualification (OQ) of the system, except that it is performed before any equipment is ever shipped and as the distribution system is installed. The designer ensures that the system is installed as per the design basis, and operates accordingly. The designer should review preliminary copies of the operating manual and maintenance manual to determine if they match the installation and to see if the system performs in accordance with them. A report is pre- pared based on the results of the inspection. The inspection is a step in quality control, and will aid not only startup but also validation. By the time the validation group starts to perform the IQ and OQ, they will be the second or third group to review the system, and validation will proceed quickly. Instrument calibration. The initial calibration should be done at the manufacturer's facility. Shipping conditions may affect the calibration while instruments are in transit. Once delivered and installed, the instrument calibration is checked during va lidation, and should continue to be checked as part of an ongoing operating procedure. The initial calibration ensures that the instruments are operating properly before they are ever shipped from the assembly plant, and the validation then moves much more quickly. The supplier should note that in order for the final calibration to be acceptable, it is necessary to use calibrated standards in the final installed system. The owner or validation group should be able to make these standards available during installation and testing. Software Simulation. System software is often the most complicated and difficult portion of the system to validate. Prior to shipment, the system can simulate operating conditions by manipulating inputs to indicate alarm conditions . It is important that the software be documented and that the simulation is thorough. The designer can determine if the proper responses occur from the control system. Once again, this review is a precursor to system validation con- ducted in the supplier's shop. Through each of the pre-validation steps, the validation group should be involved. The software protocols should be available at this time. These protocols can be taken to the shop floor or construction site for preliminary execution. The validation group should be encouraged to be present during this preliminary test so that they can anticipate the problems that may occur during formal validation. Equipment Installation, Inspection and Review As the system is installed, it must be inspected and reviewed prior to the start of validation. During the on-site pre-validation review, all deviations from the original specifications and drawings must be identified and either corrected or explained. The original drawings must be updated to reflect the as-built conditions. We should remember that there are always changes in the final installation. Changes are acceptable as long as they are documented and explained. The objective is to provide evidence that the system is installed according to Good Manufacturing Practices (GMP) requirements and will consistently produce water of desired quality.

Material Certification is one of the most critical parts of the documentation for the system. The certifications should show that all wetted materials are suitable for contact with high-purity water. In the case of stainless steel, the documentation should extend back to the mill that produces the pipe. Plastics should be documented back to the extrusion process. Materials also include gaskets, diaphragms, and other small components of the system. The question that must be answered is, "How do you know the materials meet the design criteria?" One area where certification may be lacking is from suppliers. Stills, heat exchangers and reverse osmosis (RO) units all have contact to the product water and should be documented. The supplier may not be prepared to supply the documentation unless it is requested. The request should be made in the specifications, and the existence of the documentation must be verified during the inspections. All certifications should be gathered and placed with the validation documentation. Weld Documentation. The weld documentation is as important as the material certification; however, it can be expensive to gather. At a minimum, all welds sho uld be numbered and boroscoped, including those in the heat exchangers, stills, AD units, and other locations. This requirement means the suppliers must be requested to supply the weld inspection data. Each weld should be certified and documented as part of the regular assembly procedure. Welds that do not pass inspection must be cut out and replaced. For a small additional cost, the boroscoping can be videotaped. A videotape provides a visual record for any inspector to review. It also reduces the interpretation impact of the weld inspector. Weld inspections are all maintained as part of the IQ data. The weld numbers must be marked in a permanent manner directly on the pipe and should have corresponding numbers placed on the drawings (usually the distribution isometric and the shop drawings). An engraver is an easy tool to use, and it provides a permanent mark. Operation and Maintenance Manuals. Copies of the operations and maintenance manuals should be kept as part of the validation documentation. It should be clear to the supplier that the manuals must be shipped with the unit. The supplier may not be prepared to ship the manuals if asked for them at the last minute. The delivery of the manuals with the shipment of equipment should be included with the initial request for bid. The manuals that are received will not necessarily be the final version, as changes will be made based on the final installation. The manuals should be edited by the entire team to ensure that all the necessary information is present and that it reflects the asbuilt conditions. The manuals become part of the system documentation, and should be updated as changes are made to the system. Operator Training. The system will not operate in a controlled fashion unless the operators are trained properly. The training should include operation, maintenance, and troubleshooting. Initial training is important, but there should be ongoing training. The initial training should be videotaped for review and training of new operators. The supplier can provide periodic reviews as part of a yearly maintenance program. As-Built Drawings/Data Sheets. As previously mentioned, all documentation must reflect the system as it exists. Rarely does a system get installed without some changes. The changes must be documented along with the reasons for the change. If the drawings are available on the site during construction and they are marked up as changes occur, then creating as-built drawings becomes simply a drafting process. The data sheets are not as subject to change as the drawings, but occasionally late changes are made in the design, or an unforeseen occurrence forces equipment to be re- placed. In this case, the data sheets must also be changed. As-builts also include the final shop drawings. Once again, the as-builts are part of the system documentation, and are updated when the system is modified. Hydrostatic Tests are normally viewed as a safety issue. There are also valid validation concerns that require the report to be included in the final syste m documentation. A leak in a system can permit flow in two directions, and contamination

of the product water is possible if the system leaks. The hydrostatic test provides documentation that such a situation does not exist. Flushing/Cleaning Reports are prepared by the supplier and/or the construction manager to document that no construction debris or dirt remains in the system. The main concern is the distribution system where welding material can be left in the pipe. The procedure should be submitted to the designer for review prior to implementation. When the system is flushed and cleaned, the designer should witness the procedure and document that it was carried out as planned. The designer should submit a report to accompany the supplier's documentation stating that the procedure was followed. Passivation Report. The documentation for passivation should be treated similar to the flushing and cleaning report. The passivation report prepared at this point in time usually concerns the distribution system. The equipment supplier and construction manager are responsible for ensuring that all wetted stainless steel is rendered inert by the passivation process. If there are portions of the system that cannot have chemical contact, then the report should document the dipping of the parts. The designer should witness the passivation and file a short report confirming that the procedure was followed. At the end of construction, the documentation gathering is essentially complete with respect to the installation and operation. When done properly, the IQ and OQ are complete on the day the physical construction of the system is complete. The remaining step is the process qualification (PQ). Once the PQ is complete, the documentation must be maintained like a piece of equipment. Validation, Ongoing Support, and Regulatory Authorities After the system is installed and checked by the team members, the formal validation takes place. If all the documentation and updates were made during the installation process, then validation should be straightforward and timely. As the system evolves after installation, the documentation must be kept current. The FDA may inspect the system at any time, and all documentation must represent the system as it exists at that moment. These documents are used by the validation group to support the standard operating procedures (SOPs) and the protocols. If modifications are made to the system, the re-validation will be easier if the documentation is maintained. The development of the IQ, OQ, and PQ are discussed in depth in other publications. The important thing to note is that these documents should be started early in the project and shared with all parties, including the supplier. It will be easier to prepare for validation if everyone knows what to expect. Preparation of SOPs and Validation Protocols Standard operating procedure documents show not only how the water system operates, but also how all the other special operations perform to maintain the system mechanically, chemically, and microbially. If all the documentation prior to this stage is produced and maintained, the SOP becomes an easy document to produce and validate. It flows out of the design documents and supplier's manuals. Portions of the SOP should include normal operations, startup, shutdown, sanitization, sterilization, regenerations, preventative maintenance, operator training schedules, alarm conditions, and instrument calibration. All of this information is contained within the document produced. The validation group and the designer can easily produce the document and proceed to carry out the protocols. Installation Qualification (IQ) is a protocol to check that the equipment, pipe, and instrumentation are installed properly and in accordance with the design documents. Although the IQ is discussed as part of the last section of this article, it should be drafted very early. The validation group should be included in the system design from the start. They can take the initial documentation and begin developing the protocols necessary for IQ. If scheduled properly, the IQ portion of validation is complete on the same day the system is ready for startup.

Operational Qualification (OQ) is a protocol designed to ensure that the various equipment operates as designed. This protocol includes instrument calibrations, flowrates, pump rotation, and other system factors. Similar to the IQ, the OQ may be developed very early in the design process. Validation's early involvement saves execution time later in the project. Much of the IQ and OQ can be performed before the system is fully installed and ready for start-up. A coordinated effort will save time at the end of the project. Once the system is started, the few items remaining on the protocol may be quickly verified. Performance Qualification (PO) measures the system's overall performance to establish its level of control. The PO will consist of samples that are taken and tested against the United States Pharmacopeia (USP) monograph tests and other internal standards. The master sampling plan can be developed once the points of use and sample ports are determined. If the 10 and 00 are completed when the system is in the start-up mode, then PO can begin once the system is turned over by the supplier and the construction manager. The length of the PO depends on a number of issues, some of which are determined by the system designs and construction. In general, the more proven the technology, the higher the confidence of early sample results can be. Full documentation helps the progress of the PO because potential process problems are usually discovered. Normally, to pass the PO, the system must be operated for 30 days without a failure. The PO period may be extended if the system is a unique design or process. When regulatory inspectors have not seen the technology, or are familiar with some of its problems they will want more documentation on a system to gain a level of confidence in its operation. IQ/OQ Compliance Report. As mentioned previously, the IQ and OQ may be completed before the system is put on-line. To accomplish this milestone, the various team members must be coordinated. After the successful completion of the protocols, a summary report should be prepared that discusses the results and all deviations. Since validation is the second or third group to review the system, deviations should be nonexistent. If deviations from the design do exist, either the design must be corrected, or the reason for the deviation corrected. The final report summarizes the installed and operating condition of the system and assures that it is consistent with the documentation. PQ Compliance Report. Expect excursions during the PO execution. Only the most conservative designs can be expected to pass the PO in 30 days. Even then, the re may be a disruption or an unexplained failure that causes the PO to start over. The objective should be to plan for failures, anticipate them, and take quick action to correct the cause of the excursion. One of the most common problems with failures, especially microbial, is that they are not investigated on a timely basis. Continually identifying failures as a sampling error is not acceptable. The root cause of the excursion and the corrective actions must be discussed in an incident report. If the failure is a microbiological one, then the organism must be identified and its source located. The incident reports and all other observations and test results should be presented in the PO compliance report prepared by the validation group. Once the system is shown to be under i control, then validation is compete. Many may consider the system under control and validated after the 30-day PO, but in actuality the system will not be fully tested for a year after startup. It will take a year for all potential wa ter variations caused by changing seasons to pass through the system. Sampling should continue on a regular and systematic basis for the first year, and incident reports should be kept continuously for the system whenever it is in operation. Documentation of System Modifications System designs are rarely final. Changes in feedwater quality, addition of points of use, or changes in the quality requirements can drive changes to the system. As the modifications are made, one individual must take ownership of the documentation. All documentation must reflect the existing conditions of the system. The validation file

becomes a living set of documents that illustrate how the system evolves. The single largest problem that leads to FDA-483 is a failure to maintain documents. To recreate the documents becomes expensive after the fact. It is cheaper and safer to maintain the file on an ongoing basis. Impact of Modifications. Prior to making any modifications to an existing system, a designer should be consulted. M inor modifications can build upon them- selves and eventually send a system out of control. The system should be evaluated as a unit when any modifications are made. Most times the review process is very simple and is accomplished very quickly. The objecti ve is to identity the FDA's concerns before the FDA has an opportunity to be concerned. Incident Reports must be filed for all samples that yield a result out of the specified range. The same individual who has ownership of modifications should also have ownership of incident reports. These reports are ongoing for the life of the system. As mentioned above, expect failures and be prepared to react quickly. Interaction with Regulatory Authorities Presentation of the system means presenting both the system documentation and the hardware to a regulatory inspector. It is not unusual for an inspector to be involved in reviewing the preliminary documents for a new system. The inspectors are usually pleased to support a project and to help a system avoid problems. The inspector can also comment on additional documentation required if the process is unique or unusual. The inspector should kept up to date, and presentations can be made during the design process and construction, with a final design review and final inspection of the system after start-up. If the system is existing, then the system must be presented to any inspector by individuals who know the system and the documentation. The person in the best position may be the operator, someone from the validation group, or the engineer. A strong, organized presentation of the system will provide an inspector with a degree of comfort in the system. Start with the full system documentation, including the sampling results. If necessary, review all incident reports and corrective actions. After the documentation is reviewed, the system may be visually inspected. If the documentation is thorough and complete, the visual inspection may be minimal. If the documentation is presented in a disorganized manner and the inspector does not get a comfortable feeling with the system, then the system will be given closer scrutiny. Even if the system is under control, the inspector is now in trouble-finding mode. The owner of disorganized documentation should expect the inspector to find something, however minor, just to encourage the system be better presented and organized next time. A strong working relationship with the FDA is recommended. Their expertise and preference can provide crucial insights during the critical conceptual design phases and later as the system is constructed. Inspection of the System. Depending on the type of facility and operation, the inspector mayor may not spend a lot of time with the water system. If the inspector wants to have a detailed review of the system, the operator, validation group, and engineer should be prepared to walk through the facility. Notes should be taken. Nothing should be withheld from the inspector, and all questions should be answered to the best of the group's ability. If they do not know the answer to a question, then it should be obtained before the inspector leaves. The most important attribute that must be presented to the inspector is organization. Organized documentation provides comfort with the system's operation. Summary and Conclusion Documentation of a water system is a continuous exercise that starts at the very beginning of the project, and ends when the facility is closed. A systematic approach to the task will yield the proper documentation to give the owner and regulatory authorities the confidence in the system's control. The owner's objective is to meet all regulatory requirements in a cost effective manner. The regulatory agencies want to ensure that there is no compromise or adulteration of products. Full and organized documentation

satisfies the inspector's concern with minimal interruption to a facility's operation and at a small, relative cost. Author Donald R. Keer, Esq., can be reached at 20 Brinker Drive, Doylestown, PA 18901; 215/345-5002.