In August 2013, the FDA withdrew the FDA draft Guidance “Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment” (Oct. 2003). Since this time, it has been challenging to ensure that blend (BU) and content uniformity (CU) sampling plans and acceptance criteria being used during development, validation and production are consistent with current scientific thinking. The ISPE’s Blend and Content Uniformity Working Group formed in August 2013 to develop recommendations for BU and CU sampling plans and acceptance criteria based on the FDA’s concerns, as well as providing a framework that allows multiple sampling plans, statistical approaches and acceptance criteria.
Jenike & Johanson’s James Prescott has been a member of the ISPE’s Blend and Content Uniformity Working Group since its inception and contributed to the ISPE’s two publications outlining the ISPE’s recommended approach:
- 1) Garcia, Thomas et.al., Recommendations for the assessment of blend and content uniformity: modifications to withdrawn FDA draft stratified sampling guidance, J Pharm Inn ov, 2014, (DOI) 10.1007/s12247-014-9207-0.
- 2) Bergum, James et.al., Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810, J Pharm Innov, 2014, (DOI) 10.1007/s12247-014-9208-z.
The thinking by industry and FDA regarding sampling plans, statistical analysis and acceptance criteria continues to evolve over time. We’d love to hear the challenges you are facing in this area. Jenike & Johanson is ready to assist you in addressing any concerns you may have in navigating blend and content uniformity sampling plans and acceptance criteria.