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

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

Lynda Paleshnuik | January |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

Lynda Paleshnuik | January |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

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

Lynda Paleshnuik | January |6 | Objectives

Lynda Paleshnuik | January |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.

Lynda Paleshnuik | January |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.

Lynda Paleshnuik | January |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

Lynda Paleshnuik | January | 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.

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

Lynda Paleshnuik | January | Quality assessment – brute force

Lynda Paleshnuik | January | Quality Assessment – assessing smart

Lynda Paleshnuik | January | 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

Lynda Paleshnuik | January | Questions?