GMP08003 2019 Compliance Auditing & Validation

General Details

Full Title
Compliance Auditing & Validation
Transcript Title
Compliance Auditing & Validati
Code
GMP08003
Attendance
N/A %
Subject Area
GMP - Good Manufacturing Practice
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Declan Shelly, Tom Patton
Programme Membership
SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science SG_SPHAR_K08 201900 Bachelor of Science (Honours) in Science in Pharmaceutical Science
Description

This module introduces the regulatory requirement for GMP & compliance auditing, and the tools required by an effective auditor. It introduces quality risk assessment/management, CAPA and change control theory and practice. Additionally this course outlines the various aspects of process and support systems validation utilised in pharmaceutical facilities. It will deal with the various risks inherent in pharmaceutical processing technologies and how the application of effective validation methodologies assists in the control and management of such risks.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Interpret and explain the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical products in a GMP environment.

2.

Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing and describe the concept of calibration, Identify, assess and analyse breaches of GMP, change control and select appropriate CAPA activities

3.

Describe the key elements and methodologies utilised for validation with particular emphasis on pharmaceutical processes and the product life cycle including CPP & CQA.

4.

Outline the overall concept of risk management and how the application of risk assessment and management tools can enable these risks to be gauged and managed.

5.

Identify the main steps involved in the qualification of pharmaceutical equipment, integrating processing equipment, cleaning systems, filtration systems, ancillary service facilities and utilities such as cleanrooms, sterilisation and Purified water systems..

Teaching and Learning Strategies

This module will be delivered full time. This will include lectures, augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a potential means of assessment (e.g. quizzes, uploading assignments and journals).

Module Assessment Strategies

This module is 100% Continuous Assessment.

The continuous assessment and course work will involve several assignments/case studies where students will be required to (i) demonstrate an understanding of core module concepts, and (ii) presentations on topics which demonstrates the student's ability to critically evaluate an aspect of the subject area.

formative assessment - Self-assessment tests and other forms of formative assessment are provided to students to check their own progress towards achieving the learning outcomes of the module and to motivate learning.

Repeat Assessments

Repeat Continuous Assessment.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

1 Interpret and explain the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical products in a GMP environment.

Introduction to GMP and Auditing. (QP role, QMS and role of audits in a GMP environment).

Audit Process- Audit types, techniques, auditor role. Auditing tools, Audit phases, Audit Agendas, Audit preparation, questionnaires and checklists.

2 Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing and describe the concept of calibration, identify, assess and analyse breaches of GMP, change control and select appropriate CAPA activities.

CAPA systems and change control. Preparation of non conformance statements. Carrying out audits, reporting.

GMP requirements and auditing of laboratories, sterile product manufacture, sterilisation, clinical practice and auditing paperwork.

3 Describe the key elements and methodologies utilised for validation with particular emphasis on pharmaceutical processes and the product life cycle including CPP & CQA.

Overview of validation methodologies with specific application to pharmaceutical processing.

4 Outline the overall concept of risk management and how the application of risk assessment and management tools can enable these risks to be gauged and managed.

Risk Identification, Risk Assessment and Risk Management for pharmaceutical manufacture.

5 Identify Compare the main steps involved in the qualification of pharmaceutical equipment, integrating processing equipment, cleaning systems, filtration systems, ancillary service facilities and utilities such as cleanrooms, sterilisation and Purified water systems.

Validation/Qualification of Cleanrooms, Cleaning Systems, Water Treatment Systems, Filtration Systems, Process Equipment, Sterilisation Systems, Analytical Methods, MIS.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Short Answer Questions / MCQs Continuous Assessment Assessment 40 % OnGoing 1,2
2 Case Study / Project Continuous Assessment Group Project 30 % OnGoing 1,2,3,4,5
3 Assignment Continuous Assessment Assignment 30 % OnGoing 3,4,5

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Flat Classroom Lecture 2 Weekly 2.00
Group Learning Flat Classroom Group Learning 1 Weekly 1.00
Independent Learning UNKNOWN Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Recommended Reading
2017-01-06 Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
ISBN 0857112856 ISBN-13 9780857112859

Commonly known as the Orange Guide, this book remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.

Recommended Reading
1998-08-31 Pharmaceutical Equipment Validation CRC Press
ISBN 1574910795 ISBN-13 9781574910797

While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Recommended Reading
2003-03-27 Pharmaceutical Process Validation Marcel Dekker
ISBN 0824708385 ISBN-13 9780824708382

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Module Resources

Non ISBN Literary Resources

N/A

 

Journal Resources

None.

URL Resources

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Chapter 9 - Self Inspection. : https://ec.europa.eu/health/documents/eudralex/vol-4_en

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Annex 15 Qualification and validation. : https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2015-10_annex15.pdf

udraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines. Annex 11 Computerised Systems. : https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf

General Principles and Practices January 2011, Guidance for Industry, Process Validation, FDA. : https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf

Pharmaceutical Inspection Convention (PICs)

VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION, January 2011. : https://www.picscheme.org/layout/document.php?id=152

VALIDATION OF ASEPTIC PROCESSES.: https://www.picscheme.org/layout/document.php?id=153

TEAM INSPECTIONS - STANDARD OPERATING PROCEDURE.: https://www.picscheme.org/layout/document.php?id=138

A RECOMMENDED MODEL FOR RISK-BASED INSPECTION PLANNING IN THE GMP ENVIRONMENT.: https://www.picscheme.org/layout/document.php?id=160

GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS.: https://www.picscheme.org/layout/document.php?id=155

Other Resources

None

Additional Information

None