Quality Risk Management Case Study: Outsource Manufacturing To Contract Manufacturing Organizations

Outsource Manufacturing to Contract Manufacturing.

Course Module: Quality Risk Management

Assignment Descriptor: Outsource manufacturing to Contract Manufacturing Organisations (CMO) case study

Quality Risk Management (QRM)

Candidate Name: Kevin Mansfield Tel. [phone] Candidate Signature: Kevin Mansfield Date: 13th March 2016 Class: Level 8 Pharma Cohort 22 Waterford QRM

Table of Contents

Section 1: Introduction Page 3 of 13

Introduction to Quality Risk Management

Section 2: Assignment Descriptor Page 4 of 13

QRM Assignment Descriptor

The objective of the Assessment:

Assignment break-down

Section 3: Assignment Page 6 of

For the purpose of quality, risk normally means the chance that something can go wrong. Our aim is to keep things running / operating as intended there by we need to reduce that risk i.e. risk mitigation. In order to reduce risk we have to understand it terms of its effect and how likely it is to happen this is known as risk severity and risk probability. The International Conference on Harmonization have compiled /produced a guide for pharmaceutical industries ‘ICH Q9 Quality Risk Management’ which advises on effective thoughts and tools to use for quality risk management as a valuable part of an effective quality system. An effective QMS is ICH Q10. Risk management is a valuable part of an effective quality system. It is important to consider that QRM must be considered across the product lifecycle. ICH working in consultation with the regulatory bodies of the EU, USA and Japan released ICH Q9 guidelines for the benefit of manufacturing companies on the guidelines for reducing risk. The guidelines are not exclusive or mandatory but serve to have consideration for risk mitigation in a manufacturing organization and by agencies regulating these industries. In simple terms deploying ICH Q9 affords suggested strategies that have common ground thinking on risk

The project will transferred to our manufacturing site and we will need to understand the risks associated with transferring the process in to an existing facility already manufactures drugs for other clients as well as the actual manufacturing risks. To understand risks we need to know their severity and probability and in turn suggest and understand the best risk mitigation strategy to take in consideration.

Assignment ‘break down’

For this assignment perform the following:

PART 1:

1. Draw a process map of the manufacturing process using the learnings from the QRM lectures.

2. Chose two manufacturing steps and identify the potential failure modes and potential effects for each failure mode selecting the relevant tools from the lecture slides.

3. Perform a risk assessment on these two process steps using the tools outlined in the lecture slides (e.g. FMEA/HACCP).

4. Discuss the benefits and limitations of this analytical process.

PART 2:

Is this a good risk question or not? Discuss the following risk question using the learnings from the lectures slides.

‘What is an effective control strategy for the introduction of product X to site that ensures the launch date of Dec 2015 is achieved’?

Due date: March 3rd, 2015 @