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Commissioning and Qualification This article Reprinted from The Official Journal of ISPE focuses on PHARMACEUTICAL ENGINEERING® July/August 2005, Vol. 25 No. 4 construction contractors who can deliver A Practical Guide to Construction, qualified facilities and Commissioning and Qualification presents the advantages of Documentation – and its Critical Role using a construction in Achieving Compliance contractor who can perform by Wael Allan and Andrew D. Skibo Commissioning and Qualification. ood documentation is essential for Naturally, the initial focus must be on the pharmaceutical and biotech manufac- proper construction and start-up of the facility. turing facilities to achieve regulatory Yet, a well-constructed facility that is on time, compliance. As defined by the Food within budget, and whose every system is per- Gand Drug Administration (FDA), “Validation is forming to specifications is of no value to the a documented program providing a high degree operating company if the associated documen- of assurance that a process/system consistently tation does not effectively support the qualifi- meets pre-determined specifications.” The clear cation process – it is a classic case of failing to presumption is that if the required activities see the forest through trees. In fact, the con- have not been properly documented, then they struction contractor must appreciate the sig- have not been performed. nificance of documentation, and make it an integral part of the con- Figure 1. Validation life cycle. struction planning, im- plementation, and com- missioning process from day one. Note: the term “Con- struction Contractor” is used to indicate a third party company respon- sible for construction, commissioning and qual- ification. This article fo- cuses on construction contractors who can de- liver qualified facilities. It also presents the ad- vantages of using a con- struction contractor who can perform C&Q, as well as construction led rather than design led projects. A “full service provider” could provide all of these activities. These activi- ties could be provided in ©Copyright ISPE 2005 JULY/AUGUST 2005 PHARMACEUTICAL ENGINEERING 1 Commissioning and Qualification part by a Construction Management (CM) contractor, a stages of the project, or the effort required to do it successfully commissioning contractor, a qualification contractor and the is underestimated. For example, on an 18-month project, the operating company. QA/documentation officer should be involved by the first quarter of the project – during the planning phase — to begin Turn Over Package (TOP): to organize the TOP to meet the operating company’s needs Laying the Foundation and expectations. It is well worth the small investment to Good documentation is an essential part of the Quality bring that individual on board early to avoid problems during Assurance (QA) system. For new and renovated facilities, the qualification process, and ultimately, reduce time to Commissioning and Qualification (C&Q) are key aspects of market. This approach eliminates duplication of effort by cost and schedule. Therefore, documentation – in the form of leveraging documentation from commissioning into Installa- the TOP, C&Q protocols, and other required documents – tion Qualification (IQ). IQ is approximately 30% of the quali- plays a pivotal role in ensuring a compliant facility. Every fication effort; by leveraging commissioning documentation, operating company has specific standards and methodologies a savings of approximately 50% of IQ effort could be made, for C&Q. The construction contractor’s job is to make sure resulting in an overall saving of 15% of qualification time. that the TOP enables the operating company to effectively carry out its QA strategy. Therefore, the TOP must be well- The Validation Life Cycle organized, meet the operating company’s expectations, and Just as good documentation is required to achieve regulatory provide the proper level of documentation quality. compliance, clear user specifications that are fully under- To be successful, an integrated documentation process stood by the construction contractor are required to meet the must start very early in the project in conjunction with the operating company’s unique needs and expectations. If the planning of C&Q. It must involve engineering, construction, constructor fails to understand these from the outset, the and qualification/validation. Moreover, project documenta- TOP is likely to be inadequate. Therefore, for every step taken tion requirements, and the roles and responsibilities for the by the operating company, engineers and construction con- operating company, construction contractors, and vendors tractor, a high level of integration is required to ensure that alike, must be clearly defined. the resulting documentation is appropriate, compliant, and Too often, documentation work is delayed until the later structured in a meaningful manner - Figure 1. The diagram Figure 2. Document hierarchy. 2 PHARMACEUTICAL ENGINEERING JULY/AUGUST 2005 ©Copyright ISPE 2005 Commissioning and Qualification illustrates the importance of the “definition” stage for both PHASE DOCUMENT ALL CRITICAL the operating company and the contractor. In all aspects of TYPE SYSTEMS SYSTEMS the life cycle, documentation/data is a very critical element. Good Enhance The operating company’s definitions of specifications and Engineering Documentation process requirements drive the whole project. Specifically, Practice the operating company defines the process, develops proce- Engineering Design Intent B V dures and specifications, and verifies these. In turn, the P&IDs C V construction contractor specifies and installs equipment, and Specifications B B Drawings C* V tests and qualifies making systems ready for validation and operation. This process requires that the construction con- Construction Purchasing B B Vendor B C tractor accurately “translate” the operating company’s defi- Installation C C nitions and expectations into systems, bricks, and mortar. Commissioning Lists B B Otherwise, the succeeding steps – development of the valida- Factory Testing B B tion protocol through change control – will be fraught with Field Testing B V problems, delaying time to market. Start-up Forms B V Operating Training B V Maintenance C V A Practical Guide to Project Planning Procedures B V Effective project planning is the key to a successful and cost- effective documentation effort. More importantly, is the inte- Regulatory Applicable Codes B C Inspection Certificates C* C gration of construction with C&Q. Operating companies have Permit Documents B B different preferences: some would award construction and Validation Validation Master Plan --- V commissioning to the same construction contractor; others Validation Protocols --- V would go further and award construction and C&Q to the Validation Summary --- V same construction contractor, ensuring a successful, seam- Report less integration and quality documentation, resulting in the B: BASELINE DOCUMENT - These documents are created and retained in handover of a qualified facility rather than a merely mechani- project records with appropriate project approvals. cally completed one. (There are additional variations and C: CONTROLLED DOCUMENT - These documents are created “as built” operating company contracting preferences, which are out- retained in project files with appropriate project approvals and maintained after commissioning. (Note C* means that only some of the documents in side the scope of this article.) The construction contractor’s this category require document maintenance) role in a C&Q project can be broken down into three steps: V: VALIDATION DOCUMENT - These documents are treated as controlled documents, but with the added approvals required for validation programs. • develop and agree upon the scope of work and responsibili- Additional approvals usually are limited to Quality Assurance and operations. ties Document maintenance is a formal change control process. • agree upon a methodology and develop the project execu- Table A. Documentation requirements. tion plan and quality manual • develop a project management plan incorporating docu- neers’ drawings, the construction contractor must graphi- ment management cally delineate each system and its boundaries. This has significance for the organization of the TOP, for example, if it Each of these steps has components with a significant impact is to be organized by system; it also identifies which subcon- on documentation; therefore, the construction contractor tractor and/or vendor has responsibility for what element. should fully integrate these steps into project planning. The following is a practical guide to each step and its essential Perform Risk Analysis components. The risk analysis is an extremely important activity involv- ing the operating company and construction contractor. The Step 1: Develop and Agree Upon result will capture operating company expectations by clas- the Scope of Work and Responsibilities sifying systems into critical and/or direct impact systems and At the start of a project, it is essential for the operating non-critical and/or indirect impact systems. This is signifi- company and construction contractor to agree on the scope of cant because critical systems, such as fermentation, require work, perform a risk analysis to identify critical and non- a higher level of documentation. Thus, the risk analysis critical systems, and identify who is responsible for the culminates in establishing

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