FDA’s Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation.


This 15 page guidance states that the two most common complaints the agency receives about validation issues deal with the misconception that the 1987 validation guide is a “new” requirement, and the lack of specifics in the agency’s guides.  It then explains the order of process and what context the process will be reviewed under.  It explains the intended use of prospective process validation and addresses the uses of Product Development Reports.  While Product Development Reports are not required by the FDA, they can be used by companies to summarize the required scientific data justifying the process and the product.  The guidance further states that the FDA does not require a product development SOP from the company, but they do recommend that companies develop them.


The guidance goes on to break down the components that should be included in a Product Development Report and in Pre-Approval Inspections.  It then covers details of Validation Protocols and Validation of the Process as specific to oral solid dosage forms.