quality workshop copenhagen – may 2016 · 2017-04-06 · lynda paleshnuik | may 2016 asking...

Lynda Paleshnuik | May 2016

Quality Workshop Copenhagen – May 2016

Training session

Outline

and

Objectives

Lynda Paleshnuik

PQTm Lead Quality

Assessor

1


Outline – Day 1

General talks:

Prequalification of Medicines (PQTm)

WHOPARS and labeling information

Quality assessment principles

2


Outline – Day 1 continued

Specific quality talks:

API assessment: impurities

Specifications

Stability

3


Outline – Day 2

Day 2 quality talks

Process validation

Excipients

Manufacturing solid orals

4


Outline – Day 2

Day 2 bioavailability talks

Bioequivalence and biowaivers – general considerations and Q&A

Supplementary optional talk - Assessing a bioequivalence study

5


Outline – Day 3

Final quality talk:

Assessing batch records

General topic talk:

Regulatory capacity building and facilitation of registration

Breakout sessions begin.

6


Objectives

General objectives

Increase knowledge of key quality areas: assessing the API and FPP, specifications, batch records, and stability.

Provide practical tips for assessment in general.

Breakout sessions: provides a forum for individual questions to be answered by a senior assessor.

Make note of any and all questions re PQTm and quality assessment as they occur to you.

7


8

Common assessment issues

Common issues• Data• Assessment

Examples• API• FPP Solutions

• Approaches• Shortcuts

Lynda Paleshnuik | May 2016 9


Model Dossier

The Model Dossier (MD)

Provides a model QOS/QIS and complete module 3 data for a product, 0.75 mg levonorgestrel tablets.

Includes all expected documents, approximately 100 files and thousands of pages.

Documents are redacted real dossier documents for the product.

10


Model Dossier

The Model Dossier (MD) QOS/QIS

The QOS/QIS have been perfected for the MD.

Since real documents are used, there is a certain level of redaction in the actual data.

However, the QOS includes what we expect to see, and the main data we want to assess. The QOS itself is the best example of a real dossier, ever made available.

11


Model Dossier

The Model Dossier (MD) in the workshop

Talks will sometimes include an exercise using the MD.

The MD is provided in CTD format.

Make sure you can easily access the data, either directly on the stick or by copying the folders to your laptop.

12


Model Dossier

The Model Dossier (MD) in the workshop

The structure of the MD:

Module 3

3.2.A - appendices

3.2.P - FPP data

3.2.R - blank and executed records/method summaries

3.2.S - API data

14


Asking questions

▪ Facilitators are here to provide microphones and facilitate the Q&A process.

▪ If you would prefer to write down a question, you can present it to a facilitator at any time and the question will be answered in one of the Q&A periods.

▪ If you have been given a microphone, before asking your question, please raise your arm first so we are aware of who is talking. This facilitates the answering of questions in a large group.

15


Questions?