GMP07002 2013 COMPLIANCE AUDITING AND VALIDATION

General Details

Full Title
COMPLIANCE AUDITING AND VALIDATION
Transcript Title
AUDITING AND VALIDATION
Code
GMP07002
Attendance
N/A %
Subject Area
GMP - Good Manufacturing Practice
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2013 - Full Academic Year 2013-14
End Term
9999 - The End of Time
Author(s)
Tom Patton
Programme Membership
SG_SPHAR_J07 201300 Bachelor of Science in Pharmaceutical Science SG_SPHAD_B07 201800 Bachelor of Science in Pharmaceutical Science SG_SPHAR_B07 201900 Bachelor of 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 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.

3.

Perform a systematic and independent examination of the effectiveness of a pharmaceutical quality system and contribute to and participate in a multidisciplinary team of auditors within a GMP environment.

4.

Identify, assess and analyse breaches of GMP, change control and select appropriate CAPA activities.

5.

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

6.

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.

7.

Compare the main steps involved in the qualification of pharmaceutical equipment, integrating processing equipment, cleaning systems, filtration systems.

8.

Examine the main steps involved in the validation of ancillary service facilities and utilities such as cleanrooms, sterilisation and Purified water systems.

9.

Appraise and interpret the main elements of ICH method validation and GAMP - MIS validation

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

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

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

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

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

5. Overview of validation methodologies with specific application to pharmaceutical processing.

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

7. 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 Continuous Assessment UNKNOWN 40 % OnGoing 1,2,3,5,6,7,8,9
2 Case Study Continuous Assessment UNKNOWN 30 % OnGoing 1,2,3,4,5,6,7,8,9
3 Assignment Continuous Assessment UNKNOWN 30 % OnGoing 1,2,3,4,5,6,7,8,9

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

Module Resources

Non ISBN Literary Resources

Medicines and Healthcare Products Regulatory Agency (MHRA), Rules and Guidance for Pharmaceutical manufacturers & distributors 2007 (Orange Guide). Pharmaceutical Press ISBN:9780853697190.

Pharmaceutical Inspection Convention, July 2004,  Recommendations on Validation Master Plan & Operational Qualification, Non-sterile process validation, cleaning validation, January 2011 Validation of aseptic processes.

Guidance for Industry, Process Validation: General Principles and Practices January 2011, FDA.

Other Resources

None

Additional Information

None