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

Some contractors require payment as the operations are completed. Others require one full payment after the product is manufactured. Final payment should only be made after the product and all the batch-record documentation have been received and approved by the sponsor and all product-related investigations have been completed.

Batch manufacturing record

Table IX: Batch manufacturing record.
The BMR is the final document and is affected by all previous documents. Typically, the BMR is generated electronically by the contractor's documentation and technical groups. The clinical manufacturing representative is responsibile for reviewing the draft record and ensuring that the sponsor's requests per the contract manufacturing request and the manufacturing protocol are included in the record. In addition to this review, the representative should request that the formulator and the sponsor's QA representative review the draft record and forward their comments (see Table IX). The clinical manufacturing representative compiles these comments and questions on the record and returns them to the contractor at one time. Review of the draft record by all parties at the sponsor's facility should expedite the review and approval of the final BMR.

The BMR is signed by the contractor's technical representative who prepared the record and one or more approvers at the contract facility. The BMR also is signed by the clinical manufacturing representative as the sponsor's approval and by the sponsor's QA department. The last signature to approve the record is typically the contractor's QA department.


Figure 1: Overview of documentation and responsibilities of contractor and sponsor company.
Figure 1 summarizes areas described in this article. Working with a third-party contract facility requires learning how another company operates. The more a sponsor learns about the contractor, the easier it will be to achieve a successful manufacture. Therefore, it is important to get to know a contractor by obtaining background information through visiting the site for the technical assessment and the QA audit after the confidentiality agreement has been signed.

The goal in preparing the quality agreement, manufacturing protocol, and contract manufacturing request is to specify everything that the sponsor company wants the contractor to provide. Requirements and special requests will be reflected in the cost quotation and purchase requisition. The preparation of these documents influences the final document which is the writing and execution of the batch manufacturing record.

There will always be issues that are inadvertently overlooked, but through discussions with the contractor and experience working with contractors, these issues should occur less frequently. The more information that is discussed before the manufacture of clinical batches, the smoother the operation will later be. These discussions and documents can avoid delays, save time and money, and organize the manufacturing operation for both companies to result in a win–win operation.

Peggy A. Krotzer is a scientist responsible for contract manufacturing clinical supplies at Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, PO Box 368, Ridgefield, CT 06877, tel. 203.798.5260, fax 203.837.5260,


1. "Guide to Conventional and Biotech Pharmaceutical Outsourcing Services," Pharm. Technol., Outsourcing Resources (supplement) 73–107 (2006).

2. Corporate Capabilities & Contract Services Directory, Contract Pharma (2006).

3. M.J. Valazza and G.G. Wada, "Creating a Successful Partnership with a Contract Manufacturer," Pharm. Technol. Europe 13 (5), 26–34 (2001).

4. S.H. Messing, "Getting the Most Out of Outsourcing," Pharm. Technol. Europe 12 (5), 72–74 (2000).


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