Validation and GMP Compliance Services White Paper

Integrated Commissioning & Qualification

Validation Technologies Inc.

(Abstract ISPE 5) by Ricky Pomales, P.E.

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A. INTRODUCTION_______________________________________2 B. PLANNING AND PROJECT CONTROLS__________________4 C. REQUIREMENTS DEFINITION__________________________6 D. IMPACT ASSESSMENTS________________________________7 E. ENHANCED DESIGN REVIEW (EDR)_____________________8 F. SOFTWARE QUALITY PRACTICES______________________8 G. FABRICATION QUALITY PRACTICES___________________9 H. FACTORY ACCEPTANCE TEST_________________________9 I. CONSTRUCTION QUALITY PRACTICES_________________10 J. SITE ACCEPTANCE TEST______________________________11 K. PRE-COMMISSIONING________________________________12 L. COMMISSIONING_____________________________________13 M. INSTALLATION QUALIFICATION_____________________15 N. OPERATIONAL QUALIFICATION______________________15 O. PERFORMANCE QUALIFICATION_____________________16 APPENDIX A - GLOSSARY_______________________________17 APPENDIX A - GLOSSARY_______________________________17

A. INTRODUCTION
Validation qualification of facilities a decade ago primarily was limited to the generation of protocol documentation to provide a degree of assurance that the facility systems had been installed and operate according to the requirements of the process operational or product manufacture specifications. This normally involved the generation of documents written in accordance with Good Manufacturing Practice (GMP) and comprised of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols. Depending on the facility and nature of the product, a Validation Master Plan (VMP) also may have been generated to detail, in a single document, the approach and systems to be applied to provide the required qualification. In new facilities, and also in the case of retro-validation of existing facilities, IQ and OQ were executed in isolation to any previous design, construction or commissioning activities. This early approach enabled a clean-cut qualification of the systems. But because it essentially was retrospective, a large degree of time and effort, and thus cost, was spent in re-executing construction and commissioning activities, and the attainment of certification and specification documentation, such as material certification, User Requirement Specifications (URS), etc. Another issue was the lack of benchmark guidelines for the level of qualification required. This generated a degree of uncertainty for client and validation consultants as to the level to which facilities and systems should be subjected to validation. In some cases, this led to the validation of all systems in the facility, even if they had no direct connection with the process or drug being qualified. Thus a large amount of effort and cost was spent on validating systems that probably would never be required or reviewed by a regulatory agency. This also caused inconsistencies in the application of validation between the various producer companies and even between facilities within a company. To bring a degree of consistency to the qualification process, the Food and Drug Administration (FDA) generated guidelines for its inspectors, which were used by the qualification industry as the beginnings of applying a standard approach. Subsequent to this, the International Society for Pharmaceutical Engineering (ISPE) generated a series of guides relating to the qualification process of Pharmaceutical and Biopharmaceutical facilities to incorporate and provide a baseline to the FDA and other regulatory agency requirements for qualification. These are referred to as the ISPE Baseline Pharmaceutical Engineering Guide series.

In 2001, the ISPE published Volume 5 of this series to serve as a guide to the integration of Commissioning and Qualification activities. That guide provides a basis for defining, implementing and executing the requirements of the qualification process, from the start of the design phase of a project to beyond the PQ phase. This white paper outlines the anticipated approach of the VTI Validation Group and GMP Compliance Services group in relation to the principles set out in the ISPE Baseline Guide on Commissioning and Qualification (referred to throughout the remainder of this document as the ISPE Baseline Guide). The ISPE Baseline Guide integrates the qualification activities with earlier project phases. The primary aim of this integrated approach is to reduce the qualification cost to the client by affecting a shortening in the program timeline. This shortening is achieved by moving certain aspects of the traditional stand-alone IQ and OQ execution activities into the design, construction and commissioning phases. This in turn reduces the time, as well as reducing the number of qualification personnel, required to complete IQ and OQ at the back end of the project. To affect this integrated approach, a quality program methodology must be implemented to encompass Good Engineering Practices (GEP) and GMP into the key phases of a project, which are:

PQ

Planning and project controls Requirements definition (URS, specifications, etc.) Impact assessments Project qualification plans Enhanced Design Review (EDR) [Note that since this white paper is built upon the ISPE Baseline Guide, EDR will be used instead of Design Qualification (DQ).] Software quality practices Fabrication quality practices Factory Acceptance Test (FAT) Construction quality practices Site Acceptance Test (SAT) Pre-commissioning Commissioning IQ OQ

B. PLANNING

AND

PROJECT CONTROLS

Plans provide a method of stating the intent of the activities to be addressed during the project timeline. Both high-level general approach documents and detailed specific methodology documents would be generated to "roadmap" the qualification route. A number of different phases of the project cycle can be defined in plans, but the more beneficial types are: Validation plan Commissioning plan Construction GMP plan Change management The generation of these plans will raise issues that will need to be resolved. Plans also are a useful tool to form the basis of project budgeting, scheduling and manpower strategies. They can also set rules for activities such as change control. It should be noted that plans are not static documents, but normally start as outline framework documents at the beginning of a project and evolve into a more comprehensive strategies.

B.1 Validation Plan

The qualification strategy for the project / facility is set out in a VMP. In this validation plan, the required documentation (such as URS, impact assessments, EDR, IQ, OQ, PQ and manufacturing support documents) to support the verification should be detailed. In this, the overall approach to integrating commissioning and qualification needs to be stated, including a summary of the key qualification actions to be undertaken during the construction and commissioning phases (the actual mechanics of this would be detailed in the commissioning plan). The strategy regarding the control and computer systems qualification and relation to Good Automation Manufacturing Practices, version 4 (GAMP 4), would also be outlined in the validation plan (the detailed strategy may be contained in a separate plan relating to control systems and software). On projects where the specifics of the integrated commissioning and qualification approach are still being resolved, a separate document, perhaps titled "Commissioning and Qualification Plan" would augment the VMP. This would negate the need to constantly update the whole of the VMP as the approach is developed.

B.2 Commissioning Plan

The commissioning plan details the primary activities during the vendor testing (both factory and site), pre-commissioning and commissioning phases of the project. It also should describe the management of the commissioning phase, methods for achieving the required activities and the assignment of responsibilities for these activities. The ISPE Baseline Guide gives a typical commissioning plan content list, but a few key sections would include: The role of vendor, construction, commissioning and operator team personnel in the commissioning and startup Strategy for turnover packages Use of construction Quality Assurance (QA) forms Construction change control and punch list procedures Commissioning personnel activities during construction (i.e. witnessing, auditing, etc.) Spares strategy and management (both commissioning and operational) Vendor, contractor, and commissioning personnel training Project scope training (for maintenance and operation staff) Methodology for determining the performance of a system against acceptance criteria

B.3 Construction GMP Plan

In this plan the GEP / GMP aspects of construction are addressed and the integration with the validation and commissioning plans are detailed. If the commissioning activity of the project is to be controlled under construction management, then this would be incorporated into the commissioning plan. However, if the commissioning activity is not fully under the construction management, then a plan is required to specify the procedures, QA activities and output documentation required to achieve the qualification strategy. Some items that would be addressed in the construction plan would be: Construction QA Welding QA Protection of GMP systems from construction activities Training of subcontractor personnel in GMP Subcontractor documentation turnover Work permit systems Transition to commissioning and "live" systems

The plan also must ensure that the turnover of systems, associated documentation and readiness for startup criteria are in place to transfer to the commissioning group, so this plan would be developed in conjunction with the commissioning plan.

B.4 Change Management

This plan details the controls and procedures to be used to manage the impact, implementation and tracking of changes during the project. Several change management procedures may be employed during the project, each tailored to meet the constraints of the activity phase (i.e. design changes, changes during FAT, minor construction changes not effecting impact systems, etc.). However, during the pre-commissioning and commissioning phases a single project change management is normally implemented to track the impact of changes during this phase in relation to those required to maintain the qualification trail (i.e. material certification, design specifications, commissioning changes and verification closeout). A separate software change control may be required, as evaluation and impact criteria for software changes do not always fit a physical plant change model. From IQ and OQ onwards, the owner's site change control procedures normally would be implemented.

C. REQUIREMENTS DEFINITION
The key basis for the successful commissioning and qualification process is the ability to verify that the qualified system is installed and performs to the required specifications and regulatory expectations. Thus requirements imposed by GEP, GMP and the owner need to be defined from an early stage of the project. These are normally defined in User Requirement Specifications (URS) or Functional Requirement Specifications (FRS), which provide the basis for the forward design and engineering of the project. These definition documents will need to be updated to reflect the agreedupon design so at the end of the design and fabrication process they reflect the as-built system. URS and FRS tend to be high-level, requirement documents outlining the core principles required. The next level is the individual equipment and design specifications, which will detail more specific requirements and, critical to the integrated commissioning and qualification approach, they specify the testing, commissioning and validation requirements (FAT, SAT, IQ, OQ, etc.) to the system vendor. URS also should be updated at regular intervals during the project progression.

D. IMPACT ASSESSMENTS
The methodology of impact assessment is employed to designate the systems of a facility that require validation. Usually these systems are categorized into Direct Impact, Indirect Impact or No-Impact systems and are selected dependant on a set of criteria stated in an impact assessment philosophy. Criteria would include: Product contact Critical manufacturing environment control Critical control of process parameters Affects the performance of cleaning or sterilization processes This approach reduces the "over qualification" of a facility by excluding systems from the qualification process that have no direct, critical bearing on the process. Once system level categorization has been achieved, a component level assessment is undertaken for the Direct Impact and Indirect Impact systems. This usually is performed with the aid of Piping and Instrumentation Diagrams (P&ID) where the path of the process route is analyzed to determine the components parts that are in product contact. Also, the components that have critical / secondary control functions can be determined for control instrumentation. This then forms the basis as to which items require certifications for fabrication, material, surface treatment, etc., and which of the instrumentation become "critical instruments," thus requiring more rigorous certification and calibration regimes. As impact assessments determine the basis for the systems qualification, the assessment documentation becomes part of the validation plan, and therefore must be subjected to the appropriate approval and change management procedures. Only Direct Impact systems are subjected to qualification activities. Indirect Impact and No-Impact systems generally are subjected only to commissioning activities.

E. ENHANCED DESIGN REVIEW (EDR)

The Enhanced Design Review (EDR) is a tool to document the review of the design for suitability of intended purpose and for conformance to operational requirements, regulatory requirements, GEP and GMP. The key objectives of the EDR are that the design addresses every requirement and conforms to relevant regulatory guidelines or directives. It also must verify that all impact-assessed, cGMP-critical components are documented in the design to an adequate level. The ERD normally is undertaken as a two-part process: the initial part is performed at the point that the design is issued for procurement or construction; the second part is performed when vendors or subcontractors submit detailed designs. The FDA has indicated that it is an expectation that an EDR will have been performed on Active Pharmaceutical Ingredient (and biotech) facilities

F. SOFTWARE QUALITY PRACTICES

All projects will involve the use of a process control systems such as facilitywide process control systems, as packaged equipment PLCs or, as in most cases, a combination of the two. There will be several other Indirect Impact control systems that, although not directly impacting the process, affect auxiliary processes, which impacts GMP. Indirect Impact systems include systems for laboratory data, warehouse inventory and material management. Efficient and effective commissioning and qualification of computerized systems is dependent upon the prior project activities having been adequately planned and executed. Quality should be built into the program using a structured lifecycle approach covering concept, planning, requirements, specification, design, coding, construction, testing, installation and acceptance. This will assure the quality of the delivered computerized system and facilitate a smooth, efficient startup and project delivery effort. Each computerized system should be assessed so that Direct Impact systems may be identified. While all systems should be developed with the lifecycle approach outlined above, Direct Impact systems should be developed in accordance with a formal validation plan. The plan should define the strategy, activities, deliverables, procedures and responsibilities required for the validation of that system. Comprehensive information on how to do this is provided in the ISPE Good Automated Manufacturing Practice (GAMP 4) guidance.

Note: While Indirect Impact and No-Impact systems should also follow the same overall lifecycle to meet GEP, formal qualification is not a requirement. The strategy, activities, deliverables, procedures and responsibilities determined by the project team as appropriate for the development, delivery and deployment of such systems should be documented in the relevant plan.

G. FABRICATION QUALITY PRACTICES

Whereas the project procedures and plans can ensure the conformance of the design, construction and commissioning phases of the project with the qualification objectives, issues often tend to occur when dealing with equipment vendors. Usually this occurs with the inability of the vendor to provide all of the required qualification information, or there are problems with the format / quality of the information provided. A large amount of time, and thus cost, can be spent during validation in obtaining this data from a vendor who has delivered the equipment and whose focus is then on another client's order. Vendor audits and review of QA procedures must be undertaken to ensure an understanding of, and to verify the vendor's ability to deliver, the qualification requirements. For large, critical systems, continual audits / reviews would be performed, upon which subsequent build phases would be authorized. The degree of such reviews / audits would be geared to match the relative impact of the system being manufactured, but all vendors should be audited and QA plans reviewed part of GEP.

H. FACTORY ACCEPTANCE TEST

All critical and major No-Impact equipment systems should, where possible, be subjected to a FAT prior to the equipment being shipped to the site. The FAT should be regarded as a major step in the integrated qualification strategy. When executed well, major time and cost saving benefits can be achieved by ensuring that the equipment functionality and documentation compliance with qualification requirements are in place or being resolved prior to the equipment leaving the vendor's shop. To achieve a successful FAT regime, a high degree of cooperation and buy-in is required among the design team, commissioning team, validation team, client, and vendors. Both equipment functional testing and qualification support documentation can be established during the FAT process when verification is performed by the use of a FAT test protocol. Key verification items in an FAT would include:

Functional testing: This could include commissioning tests or, in the case of packaged equipment, more developed testing to reflect the actual OQ tests. Equipment verification: Checks against schedules and schematics of equipment components and control systems. Documentation verification: Material certifications, surface finishes, passivation records, weld records, etc. These checks will ensure all required qualification documentation is in place prior to shipment. This will reduce the follow-up costs associated with locating such items at a later date. Control testing: Equipment control systems can be functionally tested. Resolution of discrepancies can be quickly rectified, as the relevant vendor personnel would be at hand. Serial PLC communications from packages to site DCS / SCADA could be tested (or simulated) to verify communication protocols are correct. As the FAT process would be part of the qualification regime, any changes or modifications must be coordinated via the agreed upon-change management procedures. There also will be a requirement to put in place mechanisms to ensure no changes to IQ-referenced parts of the FAT occur. When certain functional testing of the equipment may not be achievable due to chemical or utility requirements, such systems would need to undergo a SAT. However the non-functional qualification verification can still be performed as part of a "Document FAT."

I. CONSTRUCTION QUALITY PRACTICES

In the construction phase, quality practices must be employed to ensure the correct installation documentation and that turnover information generated is consistent with the qualification approach. In order to affect the required quality and consistency from all construction groups and contractors, training in GMP and GMP construction practices must be given. Construction management, key contractor and supervisory staff also should be trained in all aspects of the commissioning plan. A number of procedures also will be required to be put in place to ensure the qualification-related commissioning process is able to proceed without activities having to be repeated later in the project. These include:

Material control procedures Material receipt inspection procedures GMP construction and cleanliness maintenance procedures

Turnover package requirements and content format Pipeline fabrication testing and QA Punchlist and walkdown procedures During the construction phase the key roles of the commissioning and validation team would be to audit the construction of the facility and verify IQ support documentation is being correctly assembled. The turnover packages also would be audited to verify compliance to the agreed formats and GEP / GMP. The construction team would use standard, equipment installation check sheets forming the core documents of the turnover packages. These sheets, together with their data, would be used to support the pre-commissioning and IQ documentation. The auditing and verification requirements will depend on the type / scope of the facility, but same typical activities would involve: Audit of sub-vendor testing and documentation Witnessing of pressure tests and line-flushing Equipment installation checks Piping slope checks Site passivation witnessing Witnessing of instrument cold- and hot-loop testing Witnessing of critical systems pressure tests System walkdowns and snagging pre-mechanical completion Review of GMP systems protection philosophy during construction (and auditing of this for contamination risks) Weld record verification Weld inspection of orbital-welded piping systems Audit and verification of contractor material traceability documents Planning with construction management the order of system turnover to commissioning to enable support systems and utilities to come online during the initial phase of commissioning

J. SITE ACCEPTANCE TEST

The full integration testing of equipment is not usually possible during FAT. Also some types of equipment (which may require high power / voltage supplies, or the use of operational fluids which may be a hazard or not easily recoverable) could not undergo a FAT due to lack of resources at vendor facilities. In these cases the equipment systems would be tested (or retested) at the site as part of a SAT.

The SAT would comprise of a protocol supported by the vendor-test documentation. The SAT protocol would be similar to the FAT document. Since the equipment is connected to the actual facility systems, SAT would include verification that the sizing and delivery capacity of the connected utilities and the input / output process achieve requirements. If anomalies occur here, then there is usually time to make modifications to the support systems to achieve the equipment requirements. The SAT also enables the testing and "debugging" of the equipment automation hardware / software interface and communications with the "live" site control systems. As in the FAT testing, the functional testing would be performed for commissioning or, in the case of packaged equipment, more developed testing would be performed to reflect the OQ tests. Any issues relating to the functionality of the equipment can be resolved with the vendor's assistance.

K. PRE-COMMISSIONING
The boundaries of the pre-commissioning phase of a system i.e. where pre-commissioning starts and changes over to full commissioning can vary greatly and will depend on client philosophy, construction management procedures, definitions stated in subcontractor clauses, etc. In some cases the full commissioning of support utility systems (such as air, water, steam and drainage, which support the rest of the facility commissioning) is designated as a pre-commissioning activity. In general pre-commissioning entails the processes of final audit and verification of construction activities in relation to a system. The majority of this is performed before the mechanical completion of a system, and would entail the audit and verification of key construction parameters that have a direct impact on achieving the commissioning and qualification of the system. These include:

Mechanical completion walkdown and acceptance Correct installation of the system to specifications Verification of installation against P&ID Safety of layout / installation Conformation / witnessing that piping systems testing and flushing has been performed and documented correctly Piping slope checking Drainage "free route" verification Control and instrumentation cold- and hot-loop testing Electrical testing

 Fire detection and prevention systems operation Construction turnover documentation packages

The use of systems and procedures to verify the correct installation of the system during pre-commissioning can be used as the basis of the IQ verification. Thus, the IQ effort can be reduced by referencing the relevant parts of the pre-commissioning checks. Also basic equipment functionality checks would be performed during the pre-commissioning phase as well as system preparation for commissioning activities such as: Rotation direction Drive alignment Lubricant fills Removal of "transport stops," etc. Fabrication of commissioning temporary tools and devices System pressure testing Purging / inertion-filling operations Vendor setting of equipment Startup of support systems (power systems, ventilation, lighting, etc.) Startup of primary utility systems (drainage, water, air, etc.) To enable a GEP / GMP approach to this installation verification and to achieve consistency across all systems and equipment types, a set of check sheets would be used by the commissioning group which would state the checks to be performed per generic equipment type. A single check sheet for each equipment or control-loop would be generated and completed in accordance with GMP principals. Completed sheets are compiled in the commissioning file for the system. The check sheets also can be used to document basic pre-commissioning equipment functionality tests to confirm the equipment is ready for commissioning A database system that enables the generation and status-tracking of these test check sheets should be used. This should build upon the input / importation of engineering system, equipment, instrument and piping schedules (normally the final versions), from which all the relevant items can be associated with the correct system. This enables reports to be generated at a point in time to show the progress of pre-commissioning and commissioning activities by system.

L. COMMISSIONING
The commissioning phase of the system consists of several key setup and functionality testing operations, performed in a logical, step-by-step process.

The ultimate aim is to turn over a functioning and adjusted system that achieves the defined operational requirements to the operations group. Where the equipment has interaction with the site control systems, the progression of commissioning occurs with the close assistance of the controls engineers in order to set parameters to the values necessary to conduct the required commissioning tests and to "de-bug" software functionality. An approved procedure, document or protocol details the actions to be performed in the pre-commissioning and commissioning phases. This enables the commissioning engineer to complete the commissioning of a system in a progressive manner and, if detailed correctly, will minimize wasted effort of repeat actions and delays caused by support item availability. The format for a commissioning procedure will vary depending on the project requirements, client requirements and the approach detailed in the qualification plan documents. However the following sections are contained in a typical procedure: Roles and responsibilities of the parties involved in the commissioning List of the prerequisite systems required to commission the relevant system System acceptance criteria Commissioning temporary devices (such as strainers, spades, gas driers, temporary pumps, etc.) Special commissioning materials and fluids (such as flushing oil, heavier-than-air interior gases, etc.) Delicate instrument removal and spooling Critical instrument calibration acceptability and expiry checks Analytical instrumentation calibration Valve, damper and equipment line-outs Pre-startup checks Startup fills and adjustments Functional testing Control-loop tuning Equipment and control debugging Cycle development Optimization The commissioning phase also is a prime opportunity to verify that the functionality testing requirements of the OQ can be achieved. This enables

system adjustments and operations to be made under the less arduous commissioning optimization procedures as opposed to the formal OQ deviation generation and closeout regime, saving time, paperwork and providing assurance the OQ testing will proceed smoothly.

M. INSTALLATION QUALIFICATION
The IQ process verifies that the validated system has been installed in accordance with the design specifications. In the traditional approach to qualification, the IQ was a stand-alone document package executed by a separate group or consultancy company. The majority of the verification work was repeat execution of similar tasks undertaken during the construction and commissioning stages. However, apart from the double work time involved, time also was spent in obtaining the required information and certification for the qualification. In the integrated commissioning and validation approach, a large amount of the data verified and recorded during the FAT, construction, SAT and precommissioning stages can be cross-referenced in the IQ, hence reducing reexecution time. A percentage re-verification may be performed to ensure the original reference data is valid.

N. OPERATIONAL QUALIFICATION
OQ is the final verification that the operational attributes of equipment, systems or controls that can affect product quality meet specifications. OQ can be difficult if the initial testing efforts yield many deviations that must be documented, managed and resolved. Hence, in the interest of speed, OQ is accomplished AFTER all operational features have been initially checked out and any problems resolved. This is the proper role of commissioning / shakedown. This sequencing of commissioning (problem identification and resolution), followed by OQ (final confirmation that everything works properly) is especially important when sophisticated control systems are involved. It is also important when there are operational sequences that must be field-adjusted, such as cleaning, sanitization or sterilization cycles. A key prerequisite to a valid OQ is placing the software under stringent change management control. Although not necessary for every conceivable OQ test case, it is necessary for most test cases of highly automated systems. In other words, if a test is successfully performed of a particular automated function, and then the next test is performed which fails, will the corrective action somehow impact the previously performed successful test? To avoid these issues, it would be better to have all problems found and fixed before

final testing of highly automated systems. The best sequence is complete shakedown, EDR, IQ, OQ and PQ. Basic operational features will have been first tested during commissioning. If those functions were successfully tested during commissioning, and there were no changes to controls / automation that may have invalidated the results of those tests, then the commissioning documentation could be directly referenced as evidence that the test was successfully completed. The optimal situation would be to identify, prior to commissioning, which OQ test cases might be satisfied directly by commissioning tests (and not affected by potential control system adjustments during commissioning). Then, the OQ test case can be directly witnessed and documented during commissioning. The other OQ test cases (those with potential for change as automation features are commissioned) would be performed after commissioning is complete and software placed under change control. In other words, OQ references some commissioning, but performs other testing as a separate activity.

O. PERFORMANCE QUALIFICATION
While IQ and OQ can be blended with commissioning, PQ should take place only after IQ and OQ have been completed; SOPs have been fully drafted, challenged and approved; and operators have been trained on approved SOPs. Any open IQ / OQ issues or deviations must be assessed and determined (along with a positive, documented statement) that those issues and deviations would not affect the outcome of PQ testing. There should be no changes to system installation or operation during the PQ test period. It may be that PQ testing identifies the need for such a change, in which case the change should be made, appropriate installation requirements documented, and required operational test cases performed before repeating the PQ. Depending on the nature of the change, the entire PQ or selected segments would need to be started over.

Appendix A - Glossary
API CFR cGMP DQ EDR FAT FDA FRS GAMP GAMP 4 GEP GMP IQ ISPE OQ P&ID PQ PQP QA SAT URS VMP Active Pharmaceutical Ingredient Code of Federal Regulations (US) Current Good Manufacturing Practice Design Qualification (a.k.a. Enhanced Design Review) Enhanced Design Review (a.k.a. Design Qualification) Factory Acceptance Test Food and Drug Administration (US) Functional Requirement Specification Good Automated Manufacturing Practice
ISPEs GAMP Guide for Validation of Automated Systems, Version 4

Good Engineering Practice Good Manufacturing Practice Installation Qualification International Society for Pharmaceutical Engineering Operational Qualification Piping (or Process) and Instrumentation (or Instrument) Diagram Performance Qualification Project Qualification Plan Quality Assurance Site Acceptance Test User Requirement Specification Validation Master Plan