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Quality Workshop Copenhagen – January 2011

Quality Workshop Copenhagen – January 2011. Training session Outline and Objectives. Outline – Day 1. General talks: Prequalification of Medicines Programme (PQP) The new WHO/PQP quality guidelines The new WHO/PQP quality templates. Outline – Day 1 continued.

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Quality Workshop Copenhagen – January 2011

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  1. Quality WorkshopCopenhagen – January 2011 Training session Outline and Objectives

  2. Outline – Day 1 General talks: Prequalification of Medicines Programme (PQP) The new WHO/PQP quality guidelines The new WHO/PQP quality templates

  3. Outline – Day 1 continued Active Pharmaceutical Ingredient (API) talks: API assessment: Approaches and considerations Impurities: Establishing specifications (API and FPP) Finished Pharmaceutical Product (FPP) talks begin: Pharmaceutical development: ICH Q8 “minimal” approach

  4. Outline – Day 2 FPP talks continue: Dissolution case studies Supporting documents for assessment – SUPAC FPP assessment: Approaches and considerations Method and validation basics – HPLC case study Formulation development issues for solid orals Stability

  5. Outline – Day 3 Final general and FPP talks: GMP lessons for quality review Assessing production documents: executed and master records Breakout sessions begin.

  6. Objectives

  7. Objectives General objectives Increase knowledgeof key quality areas: impurities, methods and their validation, dissolution, pharmaceutical development and stability. One-on-one feedback: provides a forum for individual questions to be answered by a senior assessor. Make note of any and all questions re PQP and quality assessment as they occur to you.

  8. Objectives Providing insight into some commonly encountered deficiencies and how to deal with them. Specific objectives Introduction to the new quality guidelines and templates, and how these are being implemented in PQP.

  9. Quality Assessment Manufacturing sciences Pharmaceutical engineering/pharmaceutical technology (production methods and systems, facilities, equipment, etc.) Pharmaceutical sciences Chemistry (organic, inorganic, physical, biochemical, analytical (e.g. methodology, validation, spectral analysis)) Pharmaceutical chemistry (study of drug design) Pharmaceutics (study of drug formulation) Pharmacognosy (study of drugs of natural origin) Other fields: Math/statistics, microbiology, GMP

  10. Quality Assessment Quality assessment: Covers many fields of knowledge Complex (issues have multiple factors involved) Involves large amounts of data No two products are the same First assessment (and report!) of the original dossier is the most important part of the process.

  11. Quality Assessment “… is a primeval jungle, an amazing thicket, without escape or end, into which one would not dare to enter” Friedrich Wöhler

  12. Quality assessment – brute force

  13. Quality Assessment – assessing smart

  14. Assessing smart • Critical thinking – how deeply to assess given data ► how important is this ► how does it relate to other data ► “less important” areas can be skimmed through BUT it is important to watch for red flags that require a closer look • Continually learning • Staying on top of guidelines and advances – e.g. Q&A docs

  15. Questions?

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