The proposals in the document which I had referred in my previous message was with an assumtion that an on-line, in-process measurement system is not currently available for demonstrating blend uniformity (e.g., on-line NIR measurement of in-process blend or dosage units). This proposal was made by the Final PQRI Blend Uniformity Working Group Recommendation to FDA in the year 2002.
This proposal was meant to address concerns raised following the issuance of the FDA document Guidance for Industry, ANDAs: Blend Uniformity Analysis, (August 3, 1999) as it was related to filing requirements and post-approval commitments.
The approach described in this document was proposed as a means to satisfy the cGMP requirement for in-process testing to demonstrate adequacy of mix, as well as USP compendial requirements for the content uniformity of finished dosage forms. Alternatively, traditionally employed methods (such as the direct sampling and analysis of powder blends, in conjunction with content uniformity testing of finished dosage forms) may continue to be used to satisfy cGMP and compendial testing requirements. Additionally, on-line measurement systems may also be used to demonstrate uniformity (e.g., NIR
measurement of in-process blend samples or dosage units).
Therefore, blend uniformity ca also be demonstrated through stratified sampling and analysis as proposed in this document even for those OSD products that their uniformity of dosage units is demonstrated by weight variation.