Quality risk managment basic facilitation methods

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These presentations are compiled by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM, WHO and similar organizations.

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Quality risk managment basic facilitation methods

  1. 1. Quality Risk Management BasicRisk Management Facilitation Methods Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EDQM . WHO and similar organizations. Visit www.drugregulations.org for the latest in Pharmaceuticals. www.drugregulations.org 1
  2. 2.  Flowchart Check Sheets Process mapping Cause and Effect Diagrams (Ishikawa / fish bone)They might be helpful to support risk identification www.drugregulations.org 2
  3. 3. Flowcharts Start Activity  Pictorial Activity representations of a process Decision No Action Yes  Breaking the process Result down into its constituent steps www.drugregulations.org 3
  4. 4. Check sheets  Present information in an efficient, clear format  May be accomplished with a simple listing of items www.drugregulations.org 4
  5. 5. Process mapping The indicators may be selected based on unit operations Shows how they are interrelatedPotential Areas of Use(s) / outcomes Provides a clear and simple visual representation of involved steps Facilitates understanding, explaining and systematically analyzing complex processes and associated risks A pre-requisite for the use of some other tools ICH Q9 www.drugregulations.org 5
  6. 6. Ai Dispensing r Scale Sieving Fluidized Bed Dryer Granulation Air Process Magnesium Stearate Blendin g mapping Sieving Tabletting Packagin g Coating www.drugregulations.org 6
  7. 7. Cause and Effect Diagrams (Ishikawa / fish bone)Environment People Materials Problem statement Equipment Measurement Methods System www.drugregulations.org 7
  8. 8. Cause and Effect Diagrams (Ishikawa / fish bone) To associate multiple possible causes with a single effect Constructed to identify and organize possible causes for it Primary branch: represents the effect Major branch: corresponds to a major cause Minor branch: correspond to more detailed causal factors www.drugregulations.org 8
  9. 9. Cause and Effect Diagrams (Ishikawa / fish bone)How to perform? Define and agree a precise problem statement (put as “head” of fish bone) Think “What could be its causes?” for each node Add it to the “fish bone” diagram For each line pursue back to its root cause Consider splitting up overcrowded sections “bones” Consider which potential root causes and the need for Environment People Materials further investigation on them Problem statement Equipment Measurement System Methods
  10. 10. Cause and Effect Diagrams (Ishikawa / fish bone) www.drugregulations.org 10
  11. 11. Coating Drying Milling Analytical Temperature Spray Rate Redrying Pan Speed Time Temp Milling Gun Distance RH Screen Size Other Temperature Air Flow Porosity SamplingAtomizing Air Pressure Shock Cycle Mill Speed Method Tablet Drug Hardness Operator Precompressing Water Substance Temp/RH Main Compressing Binder Age P.S. Operator Feeder Speed Temp Process Conditions LOD Cause andTraining Press Speed Spray Rate Punch Penetration Spray Pattern HPMC  Effect Depth Methoxyl Tooling P.S. Hydroxyl Diagram Plant Feed P.S. Scrape Down Factors Frame LOD Compressing Chopper Speed Other for Tablet Hardness Mixer Speed Syloid Lactose Endpoint Raw Coating Materials Power Granulation Time www.drugregulations.org 11

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