itfg ipac technical team cmc specifications presented by bo olsson phd 26 april 2000 rockville md n.
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ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville, MD PowerPoint Presentation
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ITFG/IPAC TECHNICAL TEAM: CMC SPECIFICATIONS Presented by: Bo Olsson, PhD 26 April 2000 Rockville, MD - PowerPoint PPT Presentation


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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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Presentation Transcript
cmc specifications technical team
Focus on

Dose Content Uniformity (DCU)

Particle Size Distribution (PSD)

CMC SPECIFICATIONS TECHNICAL TEAM
ich harmonisation
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
ich q6a specifications
“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
slide5
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
slide6
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
slide7
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