Originally Published PMPN June 2001
Originally Published PMPN June 2001
Let's Talk about Equipment Validation
JETT establishes common ground for packaging equipment acquisition.
Sparked by frustration with OEM-supplied documentation, the JETT (Joint Equipment Transition Team) Consortium, an industry group of pharmaceutical companies (users), OEMs (suppliers), and consultants, was formed. The purpose of JETT is to standardize such documentation by improving communication between users and suppliers. The idea is that if both parties approach document preparation having common goals in mind and using similar language, equipment validation will be easier.
To this end, JETT has developed an equipment-acquisition model for acquiring any type of equipment package in any industry. The model uses Good Automated Manufacturing Practices (GAMP) as a foundational guideline to establish:
- The standards for the documentation deliverables to be supplied with the equipment package.
- The basic framework for specification, design, and testing.
- A relationship between project and validation documentation.
- A plan for the project life cycle.
- Standards for what is expected from the user-supplier relationship.
- A common vocabulary for project execution.
The equipment-acquisition model describes a business process for purchasing equipment aligned with GAMP guidelines. The model is intended for both individual pieces of equipment and integrated systems. For integrated systems, the user will typically define the overall system requirements and then define them for each individual piece of equipment. The model is based on a detailed communications and quality assurance plan where user and supplier requirements, specifications, and approvals are clearly defined.
Under the model, the following user activities should be performed prior to issuing equipment purchase orders:
- The master and equipment validation plans need to be written so that all parties involved are aware of the requirements for the equipment package.
- The user needs to audit potential suppliers to determine their capabilities and quality of work.
- The request for quotation (RFQ) needs to be developed and sent out to only qualified suppliers whose capabilities match the user requirements.
- A user requirements specification (URS) must be written. This is a "living" document that defines the "what" of the equipment package. It also forms the basis for the performance qualification of the equipment.
Once RFQs are sent out, potential suppliers can respond with their proposals, which should include their quality and project plans. The user then selects a supplier and issues a purchase order.
Next, the supplier develops the functional specifications, which describe how the equipment will operate to meet the URS. They are to be reviewed and approved by the user. If there is a disagreement in the approach, it can be addressed before the detailed design of the equipment takes place. The functional specifications also provide the basis for operator manuals and the operational qualification of the equipment.
Once the functional specifications are approved, the supplier can begin the detailed design, which involves drawings, specification sheets, software module specifications, and anything else that is needed to construct the equipment. Well-organized design specifications contain all the details needed for the system's maintenance manuals. They also form the basis for the installation qualification of the equipment.
Finally, the user will begin developing their system acceptance-testing plan, which may include factory or site acceptance-test plans. If the functional specifications and detailed design documentation are well developed, the acceptance-test plans are essentially tests that prove that the equipment or system meets each of the specifications. The traceability of the testing to the requirements ensures that all specifications are tested.
After the supplier and user execute the acceptance tests and the performance is deemed acceptable, the equipment is ready to be shipped. With the development of the documentation throughout the project life cycle of the equipment definition, the assembly of the maintenance and support documentation will require significantly less effort by the supplier than is traditionally required, resulting in more-timely delivery.
Ultimately, GAMP allows users to correctly install and test the equipment package, and then complete the qualification and validation process. In doing so, it offers quantifiable cost, quality, and time-to-market benefits.
Chris Roerig is manager of business development at Voest-Alpine Industries Inc., and Bret Fisk is automation design specialist at Eli Lilly and Co. To contact the JETT Consortium visit http://www.jettconsortium.com, where sample documents can be downloaded.
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