Lynda Paleshnuik | January 20111 |

Quality WorkshopCopenhagen – January 2011

Training session

Outline and

Objectives

Lynda Paleshnuik | January 20112 |

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 20113 |

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 20114 |

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 20115 |

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 20116 |

Objectives

Lynda Paleshnuik | January 20117 |

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 20118 |

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 20119 |

Quality Assessment

Manufacturing sciences Pharmaceutical engineering/pharmaceutical technology

(production methods and systems, facilities, equipment, etc.)Pharmaceutical sciencesChemistry (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 201110 |

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 201111 |

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 201112 |

Quality assessment – brute force

Lynda Paleshnuik | January 201113 |

Quality Assessment – assessing smart

Lynda Paleshnuik | January 201114 |

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 201115 |

Questions?