Lynda Paleshnuik | January 20121 |

Quality WorkshopCopenhagen – January 2012

Quality WorkshopCopenhagen – January 2012

Training session

Outline

and Objectives

Lynda Paleshnuik | January 20122 |

OutlineOutline

General talks:

Update on Prequalification of Medicines Programme

ICH quality guidances: an overview

Lynda Paleshnuik | January 20123 |

OutlineOutline

Active Pharmaceutical Ingredient (API) talks:

Options for submitting API data

API assessment: common deficiencies

Assessing specifications: API

Stability evaluation: API

Lynda Paleshnuik | January 20124 |

OutlineOutline

Finished Pharmaceutical Product (FPP) talks:

Manufacturing basics and issues: solid orals

FPP assessment: common deficiencies

Assessing specifications: FPP

Stability assessment: FPP

Lynda Paleshnuik | January 20125 |

OutlineOutline

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

Lynda Paleshnuik | January 20126 |

Breakout sessions begin.

Be preparedwith yourquestions!

Lynda Paleshnuik | January 20127 |

ObjectivesObjectives

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.

Lynda Paleshnuik | January 20128 |

ObjectivesObjectives

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)

Lynda Paleshnuik | January 20129 |

Acronyms!Acronyms!

Al: aluminumAPI: active pharmaceutical ingredientARV: antiretroviralAV: acceptance valueBCS: biopharmaceutics classification systemBE: bioequivalenceBP: British PharmacopoeiaBW: biowaiverCOA: certificate of analysisCQA: critical quality attribute CU: content uniformity

Lynda Paleshnuik | January 201210 |

Acronyms!Acronyms!

DSV: dose solubility volumeDT: disintegrationEMA: (formerly EMEA) European Medicines AgencyEP: European PharmacopoeiaEPAR: European public assessment reportEtOH: ethanolFDC: fixed-dose combinationFDA: Food and Drug Administration (U.S.)FPP: finished pharmaceutical productGC: gas chromatographyGMP: good manufacturing practices

Lynda Paleshnuik | January 201211 |

Acronyms!Acronyms!

HC: Health CanadaHPLC: high performance (or pressure) liquid chromatographyICH: International Conference on HarmonizationIPC: in-process controlsIR: infrared spectroscopyIT: identification thresholdJP: Japanese PharmacopoeiaKF: Karl FischerLOD: limit of detection OR loss on dryingLOQ: limit of quantitationMeOH: methanol

Lynda Paleshnuik | January 201212 |

Acronyms!Acronyms!

mg: milligramsMP: mobile phaseMS: mass spectrometryMU: mass uniformityNLT/NMT: not less/more thanORP: officially recognized compendiaPDG: Pharmacopoeial Discussion GroupPhInt: International PharmacopoeiaPIL: patient information leafletppm: parts per millionPQP: Prequalification of Medicines Programme

Lynda Paleshnuik | January 201213 |

Acronyms!Acronyms!

PSD: particle size distributionQIS: quality information summaryQT: qualification thresholdROI: residue on ignitionRSD: relative standard deviationR specs: release specificationsRT: retention timeS1: stage 1S2: supplement 2SmPC: summary of product characteristicsSOQR: summary of quality review

Lynda Paleshnuik | January 201214 |

Acronyms!Acronyms!

S specs: shelf-life/stability specificationsSST: system suitability testingSUPAC: scale-up and post approval changesTB: tuberculosisTLC: thin layer chromatographyTRS: technical report seriesUSP: United States PharmacopeiaWHOPAR: WHO public assessment reportw.r.t.: with respect toXRD: x-ray diffraction

Lynda Paleshnuik | January 201215 |