1. Lynda Paleshnuik | January 2012 1 |1 | Quality Workshop Copenhagen – January 2012 Training session Outline and Objectives

2. Lynda Paleshnuik | January 2012 2 |2 | Outline General talks: Update on Prequalification of Medicines Programme ICH quality guidances: an overview

3. Lynda Paleshnuik | January 2012 3 |3 | Outline Active Pharmaceutical Ingredient (API) talks: Options for submitting API data API assessment: common deficiencies Assessing specifications: API Stability evaluation: API

4. Lynda Paleshnuik | January 2012 4 |4 | Outline Finished Pharmaceutical Product (FPP) talks: Manufacturing basics and issues: solid orals FPP assessment: common deficiencies Assessing specifications: FPP Stability assessment: FPP

5. Lynda Paleshnuik | January 2012 5 |5 | Outline Special talks: Packaging and labelling – quality and WHOPAR Regulatory capacity building and NDRA approvals of prequalified products (Training and TA) Bioequivalence – general considerations and Q&A Biobatch considerations for the quality assessment

6. Lynda Paleshnuik | January 2012 6 |6 | Breakout sessions begin. Be prepared with your questions!

7. Lynda Paleshnuik | January 2012 7 |7 | Objectives General objectives Increase knowledge of key quality areas: specification, stability, general areas of deficiency. 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 2012 8 |8 | Objectives Providing insight into some commonly encountered deficiencies and how to deal with them. Provide an interactive forum for exchanging knowledge. Exam on Saturday will help us find out how best to tailor future workshops. (closed book)

9. Lynda Paleshnuik | January 2012 9 |9 | Acronyms! Al: aluminum API: active pharmaceutical ingredient ARV: antiretroviral AV: acceptance value BCS: biopharmaceutics classification system BE: bioequivalence BP: British Pharmacopoeia BW: biowaiver COA: certificate of analysis CQA: critical quality attribute CU: content uniformity

10. Lynda Paleshnuik | January 2012 10 | Acronyms! DSV: dose solubility volume DT: disintegration EMA: (formerly EMEA) European Medicines Agency EP: European Pharmacopoeia EPAR: European public assessment report EtOH: ethanol FDC: fixed-dose combination FDA: Food and Drug Administration (U.S.) FPP: finished pharmaceutical product GC: gas chromatography GMP: good manufacturing practices

11. Lynda Paleshnuik | January 2012 11 | Acronyms! HC: Health Canada HPLC: high performance (or pressure) liquid chromatography ICH: International Conference on Harmonization IPC: in-process controls IR: infrared spectroscopy IT: identification threshold JP: Japanese Pharmacopoeia KF: Karl Fischer LOD: limit of detection OR loss on drying LOQ: limit of quantitation MeOH: methanol

12. Lynda Paleshnuik | January 2012 12 | Acronyms! mg: milligrams MP: mobile phase MS: mass spectrometry MU: mass uniformity NLT/NMT: not less/more than ORP: officially recognized compendia PDG: Pharmacopoeial Discussion Group PhInt: International Pharmacopoeia PIL: patient information leaflet ppm: parts per million PQP: Prequalification of Medicines Programme

13. Lynda Paleshnuik | January 2012 13 | Acronyms! PSD: particle size distribution QIS: quality information summary QT: qualification threshold ROI: residue on ignition RSD: relative standard deviation R specs: release specifications RT: retention time S1: stage 1 S2: supplement 2 SmPC: summary of product characteristics SOQR: summary of quality review

14. Lynda Paleshnuik | January 2012 14 | Acronyms! S specs: shelf-life/stability specifications SST: system suitability testing SUPAC: scale-up and post approval changes TB: tuberculosis TLC: thin layer chromatography TRS: technical report series USP: United States Pharmacopeia WHOPAR: WHO public assessment report w.r.t.: with respect to XRD: x-ray diffraction

15. Lynda Paleshnuik | January 2012 15 |