We discuss your production needs with you and help you decide on the process equipment you need.

Some of the items we discuss are: What’s the proposed layout of the line? What required machine speeds do you need to obtain your desired output? Which filling technologies are best to employ, based on your product? Is isolation technology right for you?

The main goals of our validation strategy are to:

• Perform a GMP risk assessment.
• Address the system components (equipment, type of control systems, and others).

The validation strategy is the basis of the validation plan. The plan addresses:

• Activities, procedures, and responsibilities for establishing the adequacy of the system.
• Important requirements of the vendors (which will feed into the URS).

We help you define all the performance, technical, and regulatory requirements to create the URS. The URS is a critical document and is an indispensable tool in getting what we need from the vendor.

The URS will explain what the system is supposed to do. We will write it (with your input and review), and we provide it to the vendors selected for bidding. The document is maintained throughout the lifecycle of the equipment.

We send the URS to the vendors we have all decided appropriate. We then organize the meetings to evaluate the quotes that come in, help you evaluate them, and compare them. The winning vendors will be awarded the purchase orders. Naturally, all contractual issues related to the procurement of the equipment reside with you.

We organize the design review meetings, which are critical to the successful outcome of the project. They take place at the site of the selected vendor, with the vendor’s design engineers. The purpose of the meetings is to review and discuss, line by line, the engineering and technical details of the project, making sure that the URS is clearly understood. We will also coordinate all follow-up work.

We monitor the progress of the vendors, and we take the role of central contact between you and the vendor. As the various stages proceed (drawings, functional specifications, and further), we will review and also circulate for team reviews. We will coordinate regular project meetings among all vendors and project management, and publish meeting minutes and project schedules. In other words, we take all the day-to-day project management, so you can concentrate on your core business.

We develop the testing program to verify that the equipment meets the URS before it leaves the vendor’s facility.

• We develop the testing document.
• We manage the FAT execution.
• We provide the execution resources, or simply provide an FAT leader, participating with your client-based execution team
• We coordinate the component requirements (quantity, shipping, and more).
• We publish an issues list describing any corrective actions that need to be taken by the vendor and/or you, including when these corrections must be made (prior to shipping, or prior to site acceptance testing close, or at another time). Both you and the vendor sign off on the issues list.

• Site and vendor representatives will be present at the time of uncrating to check for damages.
• Utility drops (electrical, air, and water) will be designed and installed prior to the arrival of the equipment, by your architectural & engineering firm and general contractor.
• After rough positioning of the equipment, the vendor will be responsible for fine locating and power and utility hookup.
• As the point of contact between the building design or construction engineers and the vendor, we will manage information about.
  > Equipment rigging and routing to the install location.
  > Utility drop locations, connection type and service details.
  > Integration details of the equipment and the building.
  > Other necessary details.

We use your existing SOP formats to develop the operational and maintenance SOPs for the equipment.

The SOPs should be in draft form before the Site Acceptance Test (SAT) is executed. We can coordinate the formal training required for the on-site mechanics and operators prior to the SAT by receiving the typical training plans from the vendors and setting up an efficient full-line training program, documented using the site’s training records.

We consider the Commissioning and Site Acceptance Test to be the best and final time to catch any potential qualification protocol deviations. We develop it, coordinate its execution, publish a final report at completion, and create the punch list that results from the final report. All punch list corrections must be made and signed off on before validation of the equipment.

We develop the SAT based on the results of the FAT and the updated documentation from the vendor. We develop a SAT for 1) each piece of equipment and 2) the integrated line, verifying that all components are working correctly together. You’ll sign off on the final report before the validation step.

We develop the Installation, Operational, and Performance Qualifications (IQ, OQ, and PQ) for the equipment and integrated line, based on the requirements laid out in the validation master plan.

We can provide engineers to perform the execution of the protocols and development of the final reports; all protocols will be in the format of the user groups. Or, we can work with a validation group that you select, and provide technical support only.

This describes what we turn over to you at the close of the project — all the documents you need to have on hand for the life of the equipment.

The package generally consists of the following:

• The validation master plan
• Equipment URS (as built) documents
• Equipment FDS/SDS documents
• Executed FATs
• Executed SATs
• Validation documentation (if applicable)

We can support the start-up process of the line as you begin your commercial operations.

We would undertake the following:

• Final SOP development
• Batch Record Development support
• Operator and supervisor technical training
• Process validation support
• Aseptic process simulations (media fill) support
• Technical descriptions of the operation for regulatory filing and reporting