1. Lynda Paleshnuik | January 2011 1 |1 | Quality Workshop Copenhagen – January 2011 Training session Outline and Objectives

2. Lynda Paleshnuik | January 2011 2 |2 | Outline – Day 1 General talks: Prequalification of Medicines Programme (PQP) The new WHO/PQP quality guidelines The new WHO/PQP quality templates

3. Lynda Paleshnuik | January 2011 3 |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. Lynda Paleshnuik | January 2011 4 |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. Lynda Paleshnuik | January 2011 5 |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. Lynda Paleshnuik | January 2011 6 |6 | Objectives

7. Lynda Paleshnuik | January 2011 7 |7 | Objectives General objectives Increase knowledge of 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. Lynda Paleshnuik | January 2011 8 |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. Lynda Paleshnuik | January 2011 9 |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. Lynda Paleshnuik | January 2011 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. Lynda Paleshnuik | January 2011 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. Lynda Paleshnuik | January 2011 12 | Quality assessment – brute force

13. Lynda Paleshnuik | January 2011 13 | Quality Assessment – assessing smart

14. Lynda Paleshnuik | January 2011 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. Lynda Paleshnuik | January 2011 15 | Questions?