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FDA / CMC Services
 

Facility Design Manufacturing Quality Audit Training Due Diligence FDA / CMC

 

Our firm has organized and participated in a number of FDA Type C Meetings for review of manufacturing facility designs.  As part of our design services we recommend that our clients review their facility and planned facility operation with the FDA/CBER/Division of Manufacturing Quality, before proceeding to full architectural design and construction.  The process involves:
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Requesting a meeting with sufficient details to permit the agency to determine whether the meeting will be within their meeting guidelines.  The agency will then schedule the meeting date, time and FDA participants.

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Preparing an Information Package that describes the facility, its planned operation and the categories of products to be produced.  This package should be sent to the FDA four weeks in advance of the scheduled meeting.

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At the meeting providing a very short summary of the Information Package materials and spending the majority of the time discussing any FDA issues or concerns.  Facility flow diagrams are a significant part of this discussion.

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Preparing detailed minutes (including all FDA questions and sponsor acknowledgement or agreement) that are sent to the FDA following the meeting.

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Receiving FDA minutes of the meeting.  Both sets of minutes and the Information Package are archived by the quality organization to document the FDA's position with respect to the facility and its operation.

We also assist organizations preparing and reviewing manufacturing sections of INDs, BLAs, NDAs and PMAs.  Working with other regulatory professionals and colleagues at Merchant-Taylor International, I have participated in the preparation of a number of such documents.  In order to minimize FDA questions it is critical to:
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Provide a document that is organized in a suitable and expected format, in order that the FDA reviewer is not confused and does not have difficulty in navigating the material.  Electronic format is required for many of these documents.

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Ensure that the document is complete and provides all of the required information and that it complies with CMC guidelines for the specific product category.   It is also important that all questions or concerns previously expressed by the FDA in Pre-IND, Pre-BLA, Pre-NDA or Pre-PMA meetings or expressed in other written or telephonic communications with the agency have been fully addressed.

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Ensure that the manufacturing facility and all associated CMC information and data are ready for FDA inspection.  (Not required for IND submission.)

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