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OPMA: mixing deficiencies often trace to batch records and IPCs
Summary
The FDA presenter said mixing-related information requests most frequently concerned batch records and in-process controls, and urged developers to document process parameters and controls clearly in submissions.
The Presenter told attendees that mixing-related deficiencies are most often tied to incomplete batch records and missing in-process controls (IPCs).
"The most IRs we see have to deal with the batch record," the Presenter said when discussing mixing unit operations. He noted IPCs and process parameters were common follow-ups and that applicants should include clear justifications and IPC establishment for commercial manufacturing.
The Presenter also advised manufacturers to include data such as process parameters and evidence from exhibit batches so reviewers can assess whether the development controls will translate to commercial-scale manufacturing. The agency indicated that failing to document these elements can lead to repeat information requests and slow the review.
