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This guide defines the documentation typically required of any vendor or contractor providing construction services or equipment to FDA regulated facilities.

Table of Contents


Individual users may find that additional categories not cited below may be needed.






This document is a guide proposed by the San Francisco chapter of the International Society of Pharmaceutical Engineers for contractor supplied documentation prepared during the installation of systems in FDA regulated facilities. A committee of operating company representatives, vendors and contractors met to reach a common ground for defining what documentation would typically be required of any vendor or contractor providing construction services or equipment.

This guide defines a typical Turn Over Package (TOP) rather than establishing minimum documentation requirements. This is the type of documentation that is to be provided under good engineering and construction practices. It is found that the present nature of these documents varies greatly from vendor to vendor. Thus the goal is to identify documentation that will readily allow operating companies to demonstrate that vendor/contractor provided goods and services comply with good manufacturing and good laboratory practices for licensed products. The TOP provides the information that will allow the owner to validate/qualify, operate and maintain the equipment and facilities. It is not the intent that the TOP documents replace the traditional validation/qualification requirements of Installation Qualifications and Operational Qualifications.

All members of the committee agreed that this is a common basis which should be applied to all vendors and contractors bidding on pharmaceutical/biopharm equipment and construction services. Individual end users are free to request additional information from vendors / contractors but this should be specifically cited in the bid documents.


The following is a list of the individuals on the ISPE Committee:

Liz Yost
San Francisco, CA 94112
ph (415)570-5132
f (415)570-5132

*Jacqueline Maben
Bayer Pharmaceutical Division
4th & Parker Street
Berkeley, CA 94701
ph (510)705-5527
f (510)-705-5550

*Denny Mosher
Bay-Tec Engineering
870H Napa Valley Corp. Way
Napa, CA 94558
ph (707)252-6575
f (707)252-2027

Pete McArther
Chiron Corporation
4560 Horton Street
Emeryville, CA 94608
ph (510)420-4795
f (510)653-1130

Vera Ferreira
Chiron Corporation
2010 Cessna Drive
Vacaville, CA 95688
ph (510)420-4101
f (510)653-1130

Michael Welch
Chiron Corporation
4560 Horton Street
Emeryville, CA 94608
ph (510)420-4175
f (510)653-1130

Lisa Rose
Dome Construction
80 Carolina Street
San Francisco, CA 94103
ph (415)864-6140
f (415)864-2812

Steve Mills
DPR Construction Inc
555 Twin Dolphin Drive
Redwood City, CA 94065
ph (415)592-4800
f (415)592-1167

Clarence Chen
Genentech Inc.
460 Point San Bruno Blvd
So. San Francisco, CA 94080-4990
ph (415)225-1000
f (415)225-6000

Chris Aaron/Don Cadwalader
Kinetic Systems/Purity Systems
1013 Pardee Street
Berkeley, CA 94710
ph (510)644-0286
f (510)649-7530

Greg Burg
Quasar Engineering
1301 Shoreway Rd
Belmont, CA 94002
ph (510)420-6313
f (510)653-1130

Michael Mainini
Scios Nova
2450 Bayshore Parkway
Mountain View, CA 94043
ph (415)940-6669
f (415)962-5815

Allison Pan-Banisadr
Q.E.D. Validation and Technical Writing
5845 Jarvis Avenue, Suite 1
Newark, CA 94560
ph (510) 792-4911
f (510) 653-1130

* Indicates Committee Co-chairperson



Individual users may find that additional categories not cited below may be needed.

Architectural Finishes
Capping Machines
Chromatography/Separation Systems
Chilled Water/Circulating Glycol
Clean Steam
Clean-In-Place (CIP)
Compressed Air
D.I./R.O. Water Systems
Dry Heat Sterilizers/Ovens
Fermentation Equipment/Bio Reactors
Filling Equipment
HVAC: environmental controls
Incubators/Environmentally Controlled Chambers
Lyophilizers/Freeze Dryers
Mixing Tanks
Modular Cleanrooms
Neutralization Systems
Plant Steam and Condensate
Process Tanks/Pressure Vessels
Separation/Purification Equipment
Specialty Gas Systems
Steam Generators/Pure Steam Systems
Steam Sterilizers
Stopper Washers
Solvent Recovery Systems
Tower Water Systems
Waste Inactivation Systems/ "Kill" Systems
Vial Inspection Systems
Vial Washers
Water for Injection (WFI) Systems / Pure Water Systems
Washers (Glass, Tank, Carboys, etc.)



Industry standards for recording data during testing and startup are required for documentation integrity and to prevent misinterpretation of information.

3.1 Use black indelible ink.

3.2 Do not use correction fluid or other correction mediums.

3.3 Do not use ditto marks or arrows.

3.4 Write legibly.

3.5 Record data while performing an operation (not after).

3.6 Review acceptability of data before signing. If unacceptable, explain what action will be taken.

3.7 Fill in all spaces. Mark unused spaces as "N/A" or line with initial and date.

3.8 Correct entry errors with a single line through the error; initial and date each correction.

3.9 Initial/sign and date each entry or page.

3.10 Identify where the original copies of all documentation are kept.



4.1 Current Good Manufacturing Practice Regulations (cGMP):

Regulations set forth in Code of Federal Regulations, Title 21, parts 210 to 211 which contain the minimum methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets federal requirements as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to posses.

4.2 Installation Qualification (IQ):

Documented evidence that the system or equipment is installed according to pre-determined specifications.

4.3 Operational Qualification (OQ):

Documented evidence based on testing that the system or equipment operates within pre-determined physical parameter ranges before introduction of components or product.

4.4 Packaged Equipment:

Freestanding systems or equipment which consists of one or more components, capable of being operated independently.

4.5 Performance Qualification (PQ):

Documented evidence based on a series of production runs that the system or equipment performs consistently and produces components or products meeting pre-determined specifications.

4.6 Protocol:

A written, approved plan describing the specific validation procedure to be used, including test equipment, test procedures and acceptance criteria.

4.7 Report:

A written, approved report documenting the validation activities, including specific test methods, raw test data and summaries, any discrepancies and justifications, and a statement of whether each acceptance criterion was met.

4.8 Standard Operating Procedure (SOP):

A document that describes one procedure or specifies requirements used in the manufacturing of pharmaceutical or diagnostic products and in associated manufacturing support and quality assurance activities.

4.9 Turn Over Package (TOP):

Documentation of the design basis, fabrication, assembly, installation and testing of equipment and facilities which provides the basis for validation, operation and maintenance.

4.10 Validation:

Establishing documented evidence that provides a high degree of assurance that a specific process or system will consistently result in a product meeting its pre-determined specifications and quality attributes.



The responsibilities for generating all TOP components should be clearly defined at project inception. It is stressed that proper documentation is as important as the final equipment or facility.

5.1 The owner’s project team should provide the oversight and supervision to develop a list of turnover package requirements at the beginning of the project. They should assign responsibility for completion and assembly of TOPs. Consideration of the owner’s internal standards should be made to allow consistency and rapid integration of the new documentation. The team should typically consist of representatives of Project Management, Engineering, Validation, Maintenance, QA/QC, Regulatory, and Compliance to address multi-discipline needs.

5.2 The architectural and engineering team should ensure the assembly of detailed testing, inspection and procurement packages that reflect as-built conditions. This includes construction drawings, specifications and electronic files that are compatible with the owner’s CAD and word processing systems.

5.3 The general contractor should be responsible for TOP documents for all contracted services and equipment. This includes all work provided by the sub-contractors.

5.4 A formal acceptance procedure should be established which documents that all TOP requirements have been realized.




Changes from original design documents must be reflected in the final TOP documentation. This is normally in the form of "as built" or "record" drawings and specifications.


The architectural turnover package includes documentation prepared during design and construction of the facilities. These are the documents that should be the result of the SOPs of the design architect, owner, general contractor and subcontractors. These documents record the design and installation checkout of the various finishes, furnishings and specialty items for facilities that will be subject to validation testing and regulatory inspections.

6.2.1 Drawings and Specifications Matrix Index - lists the required data contained in each section.See appendix A. Summary of Work - Written description defining the project scope. Architectural Specifications Record Drawings (as-built) Mechanical Completion Letter with "Certificate of Occupancy" and any remaining punch list items. Room Data Sheets - defines equipment, utility requirements, cleanliness class, room finishes, air balance reports, room static pressures Code and Regulatory Analysis - type of construction, occupancy classifications, occupant load data, seismic criteria, ADA requirements, bio-safety level, hazardous materials inventory Warranties and Certifications Operation and Maintenance manuals

      A. Walls, floors and ceiling finishes: cleaning and repair procedures.

      B. Wall protection systems: installation instructions, impact resistance features and cleaning procedures.

      C. Cold boxes and environmentally controlled rooms: system operation and capacity, monitoring devices, lights, materials, access and methods of construction Purchase Orders, Field Orders and Change Orders in chronological order.

6.2.2 Finishes Cleaning agents and procedures - this information should be provided by the owner or owner’s cleaning representative. Glazing components - types and cleaning procedures Chemical resistances and wash down capabilities of finishes - walls, floors and ceilings. Hardware - types and cleaning procedures. Wall protection system - impact panels, bumper guards, door panels, etc. Installation inspection. Room finish schedule (matrix format) Floor loading capacities as defined by structural determinations

6.2.3 Furnishings Laboratory casework drawings; plans and elevations. Lighting levels: design and as-found conditions Floor mats. Fire extinguishers, cabinets and accessories. Storage cabinets - flammable and hazardous materials storage. Countertops - chemical resistance. Specialty stainless steel construction. Installation inspections. Emergency eye wash stations and showers

6.2.4 Specialties Sealants and caulking used. Pass-thrus. Cold boxes and environmentally controlled rooms. Scales. Fume hoods: testing & certification documents Clean room curtains. Bio-safety cabinets: testing & certification documents White boards/Bulletin Boards Special Signage Moisture proofing of slab; use of diaphragm materials Moisture proofing of roof; use of diaphragm materials Special equipment or features.


6.3.1 Packages Equipment

Packaged Equipment: process equipment which consists of multiple components that could be made to operate independently of any other equipment. Operation and Maintenance Manuals
      A. Equipment Specification that are not covered under section 6.2.1
      B. Description of Operation
      C. Trouble Shooting Guide
      D. Preventative Maintenance Schedule
      E. Safety Precautions
      F. Engineering Data and Reference
      G. Spare Parts List
      H. Vendor Data - if applicable Test
      A. Factory Acceptance Test
        1. Check off sheets
        2. Package check sign off
        3. input/output (I/O) verification results 
        4. Alarm set-points testing and results

      B. Site Acceptance Test

        1. Check off sheet
        2. Package check sign off
        3. Input/Output (I/O) verification results
        4. Alarm set-points testing and results Installation Documentation
      A. Installation Guidelines: includes information regarding proper unloading and uncrating techniques, recommendations for handling and setting in place, utility connection details, grounding requirements and mechanical isolation details.

      B. Pre Start-up checklist: includes data on control set-up, field adjustments.

      C. On-Site Operational Test: if applicable, supplier performs and documents on-site performance tests. Drawing List
      A. Equipment Arrangement / Layouts

      B. Piping and Instrumentation Diagram

        1.Recommended Utility Requirements
          b.Flow rates
        2.Instrument List

      C. P&ID symbols and definitions

      D. Control Panel Layouts

      E. Control System Wiring Diagrams

      F. Electrical wiring diagrams and schematics

      G. As-Built Drawings signed/dated by the manufacturer/fabricator Additional Documentation
      A. Material Specifications/Certifications for all materials used (tubing, fittings)

      B. Sanitary Pipe documents, see section 6.5.1

      C. Welding procedures specified and used

      D. Weld log books/documentation

      E. Welder Qualifications

      F. Traceable Instrument Calibration (NIST)

      G. Passivation Reports

      H. Cleaning Procedures

      I. Leak Test Reports

      J. Code certifications (for example)

        1. ASME
        2. Seismic
        3. NEC

6.3.2 Vendor Equipment

This section describes documentation required for the design, fabrication, and installation of free-standing pieces of equipment purchased independently of a vendor package or system. Examples of equipment for which this guide would apply are pumps, heat exchangers and vessels. This guide would not necessarily apply to a vendor skid or package which consists of multiple pieces of equipment, instrumentation, piping, and/or controls form various vendor or "original equipment manufacturers" (OEM). Procurement Documents
      A. Purchase Order
      B. Equipment Data Sheets
      C. Equipment Specifications
      D. P&ID issued for construction, if applicable Vendor Data
      A. Certified Fabrication Drawings
      B. ASME code Certifications (U-1 form)
      C. Written verification of conformance to Seismic Zone requirements
      D. Complete list of materials, including insulation
      E. Certified material mill test reports 
      F. Completed data sheets
      G. Cut sheets
      H. Welding procedures
      I. Welder certifications
      J. Polishing procedures Inspection and Testing
      A. Factory acceptance test procedures and documentation of results
      B. Cleaning/Passivation procedures and documentation
      C. Documentation of surface finish inspection
      D. Site acceptance procedures and documentation of results Operating & Maintenance (O &M) Manuals
      A. Installation Instructions
      B. Operating Procedures
      C. Preventive Maintenance procedures/schedules
      D. Spare parts list Other
      A. As-built P&IDs, if applicable
      B. As-built specifications

6.4 HVAC

This section covers the documentation required for the design, fabrication and installation of HVAC systems. Deliverables required for the HVAC portion of the job consist of the following:

6.4.1 Specifications and Design Drawings Specifications and Drawings in as-built state Instrumentation List and Data Sheets Airhandler fan curves and Data Sheets Coil data Exhaust fan curves and Data Sheets Blower fan curves and Data Sheets Thermostat specifications

6.4.2 Ductwork Documentation Cleaning Pressure Testing Layout Drawings in as-built state

6.4.3 Controls and Software-See Section 6.7 for detail of required information.

6.4.4 System Description Sequence of operation Functional description/schematics Control logic Start-up, operating and maintenance manuals

6.4.5 Startup/Commissioning Documentation Air balance (TAB) report with room static pressures Wet side balancing: hydraulics/hydronics HEPA filter testing and certification (DOP challenges and velocity/air supply rates) Room air change rate calculations

6.4.6 Calibration Certification/Factory Testing


This section covers the turn over documentation prepared during the design, fabrication, and installation of sanitary and non-sanitary piping systems. The documentation should be a sequential accumulation of all inspections, testing and daily activity as defined in the project specifications and contractors’ Standard Operating Procedure (SOP).

6.5.1 Sanitary Piping Systems

Sanitary piping systems refer to piping systems which directly contact raw material streams, intermediate product streams, finished product streams, pure water streams and pure steam used for sterilization-sanitization purposes. Documentation

    The following documentation should be contained within separate sections in a three (3) ring binder formulated by the contractor or third party inspection firm. Material inspection record of all materials prior to use. Weld procedure for type of welds to be joined qualified to section IX of ASME Code. Welder performance qualification record for each welder to section IX of ASME Code. Purge gas quality with certificate of analysis for each container used on project. Record of weld and inspection for each weld within the system. Disposition of any rejected weld. Record of weld coupon samples. Record Isometric drawings with location of weld s and weld numbers. Record of slope verification. Record of pressure test. Certificate of compliance for components and devices. Record of equipment calibration. Record of passivation.

    The above items should be included as a minimum but not limited to this listing. Documentation Format

    Each document/form should contain an area to identify who performed the task, initials of the inspector, and if the inspection is acceptable or rejected. Project specifications and contractor SOP’s should identify the requirements for each report. Third party inspection agencies generally provide their own forms and reports.

6.5.2 Non-Sanitary Piping System

Non-sanitary systems are defined as utility piping in facilities which manufacture FDA regulated products. Utility piping systems may or may not require documentation. Review the project specifications for specific documentation requirements. Documentation Recommendation

    It is recommended that welders qualified to section IX of the ASME Code be used for welding. The following documents are recommended to be within the turn over package: Material test reports for piping and associated pipe components. Letter of compliance for valves and specialty items. Welder performance qualification record. Weld inspection records. Flushing of system(s). Record of pressure test. Verification of Slope check Hanger/supports Commodity labels with arrows

    The above items are recommended but not limited to the listing.


An electrical turnover package includes documentation related to electrical distribution systems and components. The electrical distribution system is defined as power wiring beginning from the local utility supplier and that which distributes power to points of use within a designated area, facility or equipment skid. The electrical distribution system includes components which condition, terminate and disconnect electrical power and is typically supplied by the Electrical Contractor and Equipment Manufacturers. All testing is performed according to NETA, ASTM, ANSI, IEEE and local permitting guides. Documentation can be check lists and/or signed and dated marked-up drawings.

This level of documentation is required on the following systems:

    Emergency Power
    Uninterrupted Power Supply (UPS)
    Lighting Systems
    Fire Alarm System and voice line transmission capability
    Intrusion Alarm System and voice line transmission capability
    Specialty low voltage systems
    Specialty voice/data transmission and networking runs

6.6.1 Specifications and As-Built Drawings Electrical Specifications Single Line Diagrams/Schematics Process Motor Wiring Diagrams Shop Drawings Point-to-Point Wiring Diagrams Local control panel cross references for point-of-use locations

6.6.2 Certifications, Testing, Reports and Check Lists Electrical Equipment Inspection Report.
      A. Equipment grounding verification
      B. Wiring tags and Termination tags Cable Termination Inspection Report

      A. Verification of physical, electrical and mechanical condition

      B. Statements of proper anchorage, required clearances, physical damage, and proper alignment

      C. Documentation of cleaning of switch gear

      D. Documentation of inspection of insulators for evidence of physical damage or contaminated surfaces

      E. 12kv and greater: documentation of fire taping, suspension correctness, correctness of termination

      F. 12kv cabling Factory Test Reports

      G. Megger Test Reports Switch Gear Test Report
      A. Document switch gear data (identification, manufacturer, serial numbers)

      B. Document inspection for physical, electrical and mechanical condition

      C. Document checks for proper anchorage, required clearances, physical damage, and proper alignment

      D. Document cleaning of switch gear

      E. Document inspection of insulators for evidence of physical damage or contaminated surfaces

      F. Document performance of insulation resistance testing on each BUSS section, Phase-to-phase testing and phase-to-ground testing.

      G. Perform control wiring performance tests to verify satisfactory performance of each control feature and provide documentation Transformer Test Report

      A. Note transformer data (Identification, Manufacturer, Serial Number)

      B. Document physical, electrical and mechanical condition

      C. Document checks for proper anchorage, required clearance, physical damage, and proper alignment

      D. Document turn ratio

      E. Document that mounting is correct

      F. Document correctness of grounding Motor Check List

      A. Confirm motors were sized to specifications; could be in tabular form

      B. Verify protection procedures have been followed

      C. Document rotation test results Breaker Testing Report

      A. Note breaker data (Identification, Manufacturer, Serial Numbers)

      B. Document physical, electrical and mechanical condition

      C. Document checks for proper anchorage, required clearances, physical damage, and proper alignment

      D. Verify cleaning of breakers

      E. Document inspection of insulators for evidence of physical damage or contaminated surfaces

      F. Document trip testing of breakers Motor Control Center (MCC) Test Report

      A. Note switch gear data (Identification, Manufacturer, serial numbers)

      B. Document inspections for physical, electrical and mechanical condition

      C. Document checks for proper anchorage, required clearances, physical damage, and proper alignment

      D. Document cleaning of switch gear

      E. Document inspection of insulators for evidence of physical damage or contaminated surfaces

      F. Perform insulation resistance testing on each BUSS section, Phase-to -phase, and phase-to-ground testing and document results.

      G. Perform control wiring performance tests to verify satisfactory performance of each control feature and document results.

      H. Test over load relay and document results. Panel Board Check Lists

      A. Document inspections for physical, electrical and mechanical condition

      B. Check for proper anchorage, required clearances, physical damage, and proper alignment and document results.

      C. Document cleaning of breakers

      D. Document inspection of insulators for evidence of physical damage or contaminated surfaces

      E. Supply detailed listings of breaker labels Circuit and Outlet Assignment Checklists

      A. Verify outlets are labeled and referenced to a circuit panel

      B. Verify that emergency circuits are designated

      C. Verify that dedicated circuits are labeled

      D. Document that special grounding requirements have been satisfied Emergency Power Load Test Report

      A. Document testing under connected load conditions

      B. Document testing with an external load at 150% of connected load UPS Load Test

      A. Document testing under connected load conditions

      B. Document testing with an external load at 150% of connected load Ground Fault (GFI) Test Report

      A. Document inspection for physical damage and compliance with plans and specifications

      B. Document inspections of neutral main bonding connections for zero sequence sensing system is grounded on line side of sensor, ground connection is made ahead of the neutral disconnect link, ground conductor (neutral) is solidly grounded

      C. Document inspection of neutral main bonding connection to ensure adequate capacity for system

      D. Document inspection of zero sequence systems for symmetrical alignment of core balance transformers about all current carrying conductors

      E. Document testing of the relay pickup current by primary injection at the sensor and operate the circuit interrupting device

      F. Test the relay timing by injecting 150% 200%, and 300% of pickup current and report findings Emergency Generator Test Report

      A. Megger armature windings and report results

      B. Calibrate overcurrent relay and provide documentation

      C. Test for vibration acceptability and document results

      D. Check voltage and amperage output and document results

      E. Document that testing for surge test is within specified limits Wire Type and Size Verifications

      A. Check wire type and size, compare them to as-built specifications and document Transformer Load Test Reports

      A. Note transformer data (Identification, Manufacturer, Serial Numbers

      B. Document inspection for physical, electrical and mechanical condition

      C. Document testing for rate load correctness

      D. Test primary and secondary phase A,B,C and neutral; test voltage, amperage, RMS, peak and frequency and document all results Panel Load Test Reports

      A.Document panel data (Identification, manufacturer, Serial Numbers)

      B. Document panel rating test results

      C. Document panel load test data Calibration Certifications (On Power Mains) Documentation:

      A. Voltage meters: +/- 0.5%

      B. Amperage meters: +/- 0.5%

      C. Kilowatt Hour Meters: +/- 0.5% Support Documentation

      A. Document Panel and Equipment Identification Matrix

      B. Reference specific Cut Sheets

      C. Document utility confirmation-transformer, line size and bill rate

      D. Installation/Operation/Maintenance Manuals

      E. Reference purchase Orders

      F. Specify Recommended Spare Parts Lists


This section covers the turn-over of critical documentation prepared during the design and fabrication of the instrumentation and control systems. These documents record the design and checkout of the instrumentation and control systems that have been specified and installed.

6.7.1 Controls and Instruments

Deliverables required for the controls portion of job consist of the following: Equipment specifications that are not included in section 6.2. As-built Data Sheets on all the instruments (normally to the ISA format). Instrument list for all instruments on the project: instrument numbers, manufacturers, serial numbers, panel locations, etc. Panel drawings - electrical and assembly Cable schedules (if applicable) Loop drawings Manufacturers Manuals & Cut Sheets Operation and Maintenance manuals Completed bench check forms Completed loop checkout forms Completed field calibration forms (if applicable) Control system architecture

6.7.2 Software

Deliverables required for the software portion of job consist of the following: Software Design Description

    This document is the first one developed and is the controlling document. It is typically developed from the P&IDs and the Process Description. It specifically details the control system operation as well as describing the operator interface. It includes software listings, critical parameters, security-access levels, system recovery capabilities and screen hierarchy. Software Test Plans

    This document tests the integrity, functionality and security of the code as it relates to the Software Design Description. In addition to the normal operation, the software’s response to abnormal conditions is tested. This tests the software and control system as completely as possible using simulated inputs and viewing outputs. Operational Tests

    This document tests the functionality of the software controls and equipment. This will functionally test the entire system prior to turn-over to the owner. Programming Documentation

    This is the normal documentation printout of the logic, controller configuration, operator interface, and the distributed control system (DCS) printouts. These should have comments explaining each section of code in plain English so a non programmer can determine the function of each section of code. In ladder logic this is handled by Rung Comments, in C code, basic, etc. this is handled by "Comments". In some systems that do not support these types of commenting, a separate document may need to be provided explaining the sections of code. Systems such as DCS configuration do not require additional commenting.