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ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville, MD

ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville, MD. Focus on Dose Content Uniformity (DCU) Particle Size Distribution (PSD). CMC SPECIFICATIONS TECHNICAL TEAM.

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ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville, MD

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  1. ITFG/IPACTECHNICAL TEAM: CMC SPECIFICATIONSPresented by: Bo Olsson, PhD26 April 2000Rockville, MD

  2. Focus on Dose Content Uniformity (DCU) Particle Size Distribution (PSD) CMC SPECIFICATIONS TECHNICAL TEAM

  3. OINDP are amenable to the principles set forth by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH Harmonised Tripartite Guideline on "Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances" (Q6A) provides a process for establishing specifications. ICH: HARMONISATION

  4. “The justification [of specifications] should refer to relevant development data, pharmacopoeial standards, test data for drug substances and drug products used in toxicology and clinical studies, and results from accelerated and long term stability studies, as appropriate. Additionally, a reasonable range of expected analytical and manufacturing variability should be considered. It is important to consider all of this information.” (62 Fed Reg 62892) ICH Q6A: SPECIFICATIONS

  5. Hypothesis: The current state of OINDP technology may not allow general compliance with the DCU specifications in the draft FDA CMC Guidances. To date, more than 12 companies have initiated the process to collect a world-wide blinded database of more than 45 products to examine actual DCU capability of OINDP Initial assessment by July 31 DCU

  6. ITFG/IPAC position: The specifications in the draft Guidances should be based upon sound statistical practices such that they can be translated into a quality requirements. Investigate, using database, alternate DCU specifications ICH Q4 (Pharmacopoeial Harmonisation) draft proposal Dr. Walter Hauck's Approach ISO 2859-1 Approach Other Approaches DCU

  7. To date, more than 12 companies have initiated a process to collect a world-wide blinded database of more than 40 products to examine actual PSD capability of OINDP Initial assessment by July 31 Purpose of PSD survey Examine the relevancy of the mass balance requirement as a product specification versus system suitability requirement. Investigate if fewer than 3-4 stage groupings can provide equivalent control. PSD

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