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
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.
Table IX: Batch manufacturing record.
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 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.
Figure 1: Overview of documentation and responsibilities of contractor and sponsor company.
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, firstname.lastname@example.org
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4. S.H. Messing, "Getting the Most Out of Outsourcing," Pharm. Technol. Europe 12 (5), 72–74 (2000).