DRUG REGULATIONS AND QUALITY ASSURANCE

INTRODUCTION

This module has been designed to give an introduction to the scientific and managerial principles of Quality Assurance (QA) in the manufacture of medicines. It also aims to develop an understanding of current regulatory practice in the licensing of drugs, and to increase the awareness of major international issues such as, for example, those relating to the counterfeiting of drugs

The course gives an overview of the principles of QA, Quality Control (QC) and Good Pharmaceutical Manufacturing Practice (GMP), which apply to pharmaceutical companies in Europe and North America.

AIMS:

To introduce the essential principles of quality assurance in drug manufacture.   To review the current regulatory framework for drug manufacture and control.   To develop communication skills relating to technical management portfolios.

LEARNING OUTCOMES

1) Explain the key managerial, technical and regulatory issues relating to pharmaceutical quality assurance in the industrial and health service environment.

2) Assess and recommend managerial options for QA and regulatory problems in Case Studies typical of current industrial practice.

3) Analyse, discuss and present technical and managerial information to a peer group.

4) Summarize technical, QA and managerial issues relevant to drug manufacture.

5) This module provides opportunities for students to develop their skills of teamwork, problem-solving and communication.

Outline Syllabus:

Drug Regulations

Systems for regulatory control of drugs; the Licensing Authorities, MCA, FDA, EMEA. Requirements for Pharmaceutical Product License approval (dossier, Expert Report, submission procedures). Drug Control Agencies, drug policy development, issues involved in drug counterfeiting. Drug safety, drug surveillance programmes, international issues.

Quality Assurance Systems in Pharmaceutical Industry

Introduction to QA systems; principles of global QA and AC, GMP; EU Guide to GMP and the "Orange Guide" for pharmaceutical manufacturers.

The role of national and international pharmacopoeia. Design of a pharmacopoeial monograph for drugs and medicines control: key managerial issues in validation of analytical methodology. Case studies in small Syndicated Workshops with presentations to plenary session on:

(A) Typical sources of problems in QA systems (illustrated by ABPI Film)

(B) Sir Cecil Clothier's "Report on the use of contaminated infusion fluids in Devonport Hospital