Validation Commissioning
Documents:
A Checklist Approach for Facility Validation
By Daniel J. Tisak, Bala Consulting Engineers
&
Robert E. Koster, SmithKline Beecham Pharmaceuticals
Qui non est hodie cras minus
aptus erit.
He who is not prepared today
will be less so tomorrow. – Ovid
W
process, accelerate start-up, enhance documentation and ensure
that the pharmaceutical product is
produced in a GMP-compliant facility. The objective of the VCD is to
clearly and concisely identify the
documentation and services that the
vendor must provide for the commissioning program, including the
facility validation process. Successful completion of the VCD supplies
the basis for IQ/OQ development
and execution. Using VCDs has an added benefit:
Through coordination of testing, repetition of work
between related commissioning and qualification
activities is minimized, thereby reducing costs. Thus,
VCD use can enhance a reasonable approach to validation. This is especially significant for start-up firms
that do not have the resources to manage complex
policies.
❝Successful
completion
of the VCD
supplies the
basis for IQ/OQ
development
and execution.❞
hen pursuing the facility
validation process, it is
essential to be prepared.
Part of the preparation involves securing documentation, testing assistance
and other services from vendors for
the success of the project. Even those
in the industry who lack expertise in pharmaceutical
validation nonetheless understand and appreciate the
value of reliability, and the need to incorporate the aid
and expertise of the contractors and vendors for testing
and documentation. Yet the preparation and planning
required to make sure that necessary documentation and
services are provided can become a difficult, logistical
challenge. A practical, effective way to ensure the provision of services is through the use of a Validation
Commissioning Document (VCD). The VCD designates document and testing requirements. The VCD
identifies the shared responsibility and cooperation that
must occur between the owner, construction manager
and vendor for documentation and testing.
Objective
The VCD is a planning tool for the commissioning program. A commissioning program that is wellplanned and executed will facilitate the validation
Procedure
During a project’s design phase, a VCD is filled
out for each system or piece of equipment and sent to
the vendor as part of the bid package. Inclusion of
VCDs in the bid package fosters early planning and
preparation. It also helps the vendor to more realistically anticipate and assess the installation, testing and
documentation costs of the system or equipment to be
provided, based on the needs of the owner. One VCD
may cover a number of similar equipment pieces.
Special Edition: Facility Qualification
73
Daniel J. Tisak & Robert E. Koster
VCD Checklist
The VCD contains a simple checklist that is
prepared by the validation contractor and approved
by the pharmaceutical firm’s project manager or
representative. The checklist is divided into seven
sections. Each section lists many related types of
documentation and services. Tasks required for
individual equipment pieces are checked. The following list is an example that identifies the sections and some of the tasks that the VCD should
contain:
1. General Documents
■ Specifications.
■ Purchase Orders.
■ Engineering Documentation.
■ Process Flow Diagrams (PFD).
■ Piping and Instrumentation Diagrams
(P&ID).
■ Operation and Maintenance Manuals
Warranties.
2. Construction/Installation/Certification
Documents
■ Installation Requirements.
■ Quality Standards.
■ QA/QC Reports from Subcontractors or
Vendors.
■ Material Certification.
■ Welding Procedure.
■ Welding Inspection.
■ Weld Map.
■ Noise Data Sheets.
3. Testing and Commissioning Activities
■ Factory Acceptance Testing.
■ Site Acceptance Testing.
■ As-Built Drawings.
■ Air Balance Report.
■ Duct Pressure Test.
■ Filter Certification.
■ Megger Testing for Power Cables.
■ Motor Rotation Verification.
■ Ground Continuing Testing
IEEE/ANSI/ASME/NEMA/ASTM
Certification.
74
Special Edition: Facility Qualification
4. Equipment Data
■ Component Listing.
■ Spare Parts List.
■ Lubrication List.
■ Motor List.
■ Single Line Diagram.
■ Motor Wiring Diagram.
5. Instrumentation/Calibration
■ Instrumentation Checklist.
■ Calibration Certificates with NIST
Traceability.
■ Calibration Procedures.
6. Computerized Systems
■ Quality Program Software Development
Standards.
■ Functional Specification.
■ Flow Diagrams.
■ Pseudocode.
■ Source Code.
■ Annotated Ladder Logic.
■ Programming Manuals.
■ I/O Rack Address Verification.
■ Control Panel Hardware and Set-up
Document.
■ Component Location Verification.
■ Automatic Valve Operation Check.
7. Training
■ Factory Training.
■ Site Training.
■ Certificates of Completion.
When filling out the VCD checklist, the validation
contractor refers to the engineering design specifications, the owner acceptance criteria, and FDA regulatory guidelines to determine the requirements. For
example, if the specification indicates the requirement “SA-240, Grade 316L Stainless Steel,” then the
requirement named “material certification,” listed in
Section 2, Construction/Installation/Certification, is
checked. Once the checklist has been completed, it
is routed to the owner’s project manager for approval.
After approval, the checklist is distributed to the construction manager and vendors. Figure 1 is a sample
from one section of a VCD.
Daniel J. Tisak & Robert E. Koster
Figure 1
VCD Sample
VCD Number
Equipment Number:
VCD007
3-CENT-7501, 3 CENT-8501
Description:
Material Requisition Number:
Building 3 Centrifuge
1-7-97-0000057
Section 3: Testing and Commissioning
Date:
March 25, 1997
Revision:
01
Protocol:
BFP08011
Page:
Subcontractor
Vendor
Owner
Factory Acceptance Testing (FAT)
x
x
FAT Methodology in Bid Package
x
Approved FAT Procedure
x
FAT Acceptance
x
5
Comments
Tester CVs
Dye Leak Test Report
Start-up Procedures Data Sheet
Site Acceptance Testing (SAT)
x
x
Approved SAT Procedure
SAT Results
x
x
x
x
Tester CVs
Installed Setpoint/Operating Data Documented
Cases to Consider
Recurrent FDA-483 observations include “inadequate documentation” and “incomplete test cases.”
In some cases, the vendor and owner may perform
the reliability tests but fail to document them in sufficient detail. In other cases, the test procedures
overlook assumptions that were made during the
development of functional requirements. Several
approaches may be taken to address documentation
and testing requirements. One approach uses a qualification protocol during the design phase to identify documentation and testing requirements. The
qualification protocol typically was previously written for a similar project, system or set of equipment.
However, this approach may be insufficient for
developing as-built test packages, especially for new
x
equipment and systems such as those that are computerized. For example, suitable test procedures for
computerized systems identify operator actions and
test results, but these may not be known in detail
early in the design phase. A more practical approach
uses the VCD to identify the requirements for documented factory and site acceptance testing. The test
procedures can be evaluated for detail and accuracy
later, during the construction phase, and incorporated in the qualification protocol before actual testing.
Industry Comparison
The VCD uses a conceptual approach that has
been employed by other industries with different
regulatory concerns. For example, the planning
process for software development includes a stateSpecial Edition: Facility Qualification
75
Daniel J. Tisak & Robert E. Koster
ment of what the customer wants the seller to do,
called a Statement of Work (SOW). The SOW indicates deliverables and testing requirements. The
Nuclear Regulatory Commission (NRC) has its own
detailed testing requirements for the nuclear industry, and the Department of Defense (DOD) has military specifications that indicate the procurement
and task requirements for establishing reliability of
systems and equipment.
Summary
The VCD is an organizational tool and a major
communication path for the project. Its use in the
facility validation process is important, therefore,
because organization builds consistency and consistency yields reliability. Moreover, the VCD identifies the shared responsibility and coordination that
must occur between the vendor, subcontractor and
owner. Finally, the use of VCDs supports Good
Engineering Practice (GEP), for GEP suggests that
the vendor documents be organized, properly witnessed and approved.
References
1. Wesley P. Wheeler, “Commissioning: A Vital Precursor to
Validation,” Pharmaceutical Engineering, 4 (July/August,
1994), p. 48.
2. Wayne T. Flaherty, “Facility Validation: Management Issues,”
Journal of Validation Technology, 2 (May, 1996), p. 247.
3. Edward T. Luckiewicz and Henry J. Sandler, Practical Process
Engineering (XIMIX, Inc., 1987), p. 9.
4. Orlando Lopez, “Diagnosing and Treating FD-483s and
Warning Letters,” Journal of Validation Technology, 2 (May,
1996), pp. 190-191.
5. Scott E. Donaldson and Stanley G. Siegel, Cultivating
Successful Software Development (Prentice Hall PTR, 1997).
pp. 244-257.
6. Donaldson and Siegel, Cultivating Successful Software
Development, pp. 62-65.
7. See, for example, MIL-STD-785B, Reliability Program for
Systems and Equipment Development and Production (5
August, 1988) and MIL-Q-9858A, Quality Program
Requirements (16 December, 1963).
8. ISPE and FDA, Pharmaceutical Engineering Guides for New
Facilities, Volume 1, Bulk Pharmaceutical Chemicals, First
Edition, (June, 1996), p. 74.
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