Preparing Documentation to Support Clinical Supply Manufacture - Pharmaceutical Technology

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Preparing Documentation to Support Clinical Supply Manufacture
This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.

Pharmaceutical Technology

The contract manufacturing request also includes information about how the product is to be bulk packaged, labeled, and shipped. (Packaging the product at the contractor's facility for the clinical study is not covered in this article; however, the type of documents mentioned in this article will support the packaging operation at a contract facility.)

Include your product-lot number and any storage statement that the contractor will be required to include on the labels such as "under refrigerated conditions (2–8 C)." The sponsor may request the contractor to ship all refrigerated product with temperature monitors to verify the conditions during transit. The temperature monitors (electronic data loggers) would be procured by the sponsor and shipped to the contractor with operating directions. Once the temperature monitors are received at the sponsor's facility with the product, the monitors can be downloaded to view the transportation conditions.

The contract manufacturing request includes the delivery date of samples, product, and batch documentation. Specify the name and address of the person at the sponsor company to whom the in-process samples, finished product, and batch record documentation are to be sent.

The clinical manufacturing request should be sent to the sponsor company's contact in the technical group at the contract facility who will prepare the batch record documentation, the contractor's project manager, or the business development representative.

Cost quotation

Table VII: Cost quotation.
The contractor's business development group prepares the quote for the cost of manufacture. This document should itemize, at minimum, the costs for conducting analytical tests on the raw materials, QC support for in-process and release testing, the generation of batch documentation, the manufacture of the batch, and the QA audit of batch documentation. The document should also state that one sponsor QA facility audit per year is included in the cost (see Table VII).

The cost quotation should be sent to the clinical manufacturing representative or the sponsor company's purchasing department. The purchasing department reviews the cost quotation to confirm that the services to be provided coincide with the cost stated and either accepts the charges or negotiates costs with the contractor.

Additional charges may include preparing a cleaning verification method for the API if the sponsor does not already have a procedure in place that can be transferred by the sponsor's analytical department to the contractor. There may be an extra cost to perform equipment cleaning verification at the conclusion of the batch. A one-time cost may be required to develop a microbial validation procedure for the finished product.

The cost quotation also should include a statement that additional supplies, including reference standards, excipients, and other materials required for the project, will be charged to the sponsor. Additional charges may also be appropriate in unique circumstances such as the handling of potent compounds. If the clinical study will be conducted in Europe, there may be an additional cost for EP testing of the raw materials. The quote also should include a statement for the cost incurred in the event that the sponsor must cancel or postpone the date of manufacture.

The clinical manufacturing representative is responsibile for reviewing the cost quotation to ensure that the services to be provided are accurate. The contractor may ask the sponsor for a signature to confirm agreement of the manufacturing cost.

Purchase requisition

Table VIII: Purchase requisition.
The clinical manufacturing representative may prepare the purchase requisition for the manufacture. It is a good idea to attach the cost quotation, the manufacturing protocol from the contractor, and the contract manufacturing request to the purchase requisition (see Table VIII). The purchase requisition and attachments are then forwarded to the purchasing department for execution.


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