Short Title:Regulatory Affairs
Full Title:Regulatory Affairs
Module Code:RGAF H2040
Credits: 4
NFQ Level:6
Field of Study:Pharmacy
Module Delivered in no programmes
Reviewed By:JOHN BEHAN
Module Author:JOHN BEHAN
Module Description:The aim of this module is to train the students in regulation and validation within the pharmaceutical industry. The students will be able to carry out audits of a working environment. The will be familiarised with legislation and with statutory bodies concerned with regulation in the pharmaceutical industry.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Interpret and apply regulatory guidelines to the workplace
LO2 Carry out regulatory audits of a working environment
LO3 Identify non-conforming issues and recommend corrective actions
LO4 Understand the principles of validation and write validation plans
LO5 Explain the role of the main statutory bodies with responsibility for implementation and enforcement of environmental legislation
LO6 Summarise the major Statutory Instruments made under the Safety, Health and Welfare Act, 1989
LO7 Describe the enforcement procedures relating to the storage and handling of hazardous materials
Pre-requisite learning
Co-requisite Modules
No Co-requisite modules listed

Module Content & Assessment

Content (The percentage workload breakdown is inidcative and subject to change) %
Regulation & Control of the global pharmaceutical sector
Globalisation of the pharmaceutical sector; implications for control of the industry. IMB, EMEA, FDA, Japanese Ministry for Health, National Standards Authority of Ireland (NSAI), EPA and Health and Safety Authority. International Conference for the Harmonisation of Regulations (ICH) ICH: Scope, structure, rationale and authority. ICH guidelines for pharmaceutical production. Mutual recognition policies for the licensing of medicinal products. FDA: Scope and History. Structure of FDA. Authority and areas of activity of FDA. FDA Code of Federal Regulations. IMB: Scope and History. Structure and Authority. Areas of activity; licensing, pharmacovigilance, IMB guidelines. clinical investigations, registration, certificates of sale. Guide to overseas FDA inspections. Guide to IMB inspections .
Validation: Definition of The Validation Process. Historical development of validation. Overview of the documentation involved in validation. Validation Master Plans. Validation Protocols. The importance of specifications and limits in validation. Prospective, Concurrent and Retrospective Validations.
Pivitol issues in international pharmaceutical regulations
The Thalidomide disaster, transmissible retroviral and Spongiform Disease, impact on the industry. Regulatory cases studies from the Irish and US pharmaceutical sector.
Guide to licence applications for pharmaceutical manufacture
Preparation of New Drug Applications, Abbreviated Drug Applications, Orphan Drugs Applications, and licences for the manufacture of generic drugs. Drug development: Overview of drug R&D and the importance of design controls. Preclinical studies and Clinical Trials (Phase I, Phase II and Phase III) and their role in drug applications. The licencing process, post-market survelliance and adverse event reporting mechanisms.
Environmental Legislation
The Environmental Protection Agency act. EPA: scope and authority. IPC licencing and waste management principles and regulation. Environmental monitoring requirements for manufacturers of bulk and finished dose pharmaceuticals. Environmental Management systems –ISO 14000 and EMAS. Overview of Irish planning Process and Environmental Impact Assessment (EIA) process and legislation. Preparation and assessment of Environmental Impact Statements (drafts).
Health and Safety Legislation
Safety, Health and Welfare at Work (SHWW) Act, No. 7, 1989. Secondary legislation – S.I. No. 44 of 1993 (General Applications). Fire & Emergency planning. HSA (enforcement) – Approved Codes of Practice (ACoPs). Hazard identification, risk assessment, and controls (draft safety statement).
Storage and Handling of Hazardous materials
Hazardous Chemical Materials - Chemical Agents Regulations 1994; Physicochemical hazards; Toxicological hazards; MSDS; Incompatible materials; Isolation, Separation, and Segregation, Hazardous Biological Materials - Biological Agents Regulations 1998; Classification 1, 2, 3, 4; Controls 1, 2, 3, 4; Ionising Sources – ALARA principle, Ionising Radiation Regulations 1994
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment n/a   30.00 n/a
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination   70.00 End-of-Semester

IT Tallaght reserves the right to alter the nature and timings of assessment


Module Workload

This module has no Full Time workload.
This module has no Part Time workload.

Module Resources

Required Book Resources
  • 1995, Guide to the Safety Health and Welfare at Work Act, 1989, and the Safety Health and Welfare at Work (General Applications), HSA
  • Dept. of Labour (1955-1994), Regulations and Directives relevant to Occupational Safety, Health and Welfare at Work, Government Publications
Recommended Book Resources
  • J. Vesper 2000, GMP in practice: Regulatory Expectations for the Pharmaceutical Industry, Serentec Press
  • L. Steinborn 1995, GMP - ISO 9000 Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Interpharm Press
  • A. S. Lubiniecki and S. A. Vargo 1994, Regulatory Practice for Biopharmaceutical Production.
  • R. Byrne 1995, A Guide to Safety Health and Welfare at Work Regulations, Nifast
  • Byrne & McCutcheon 1995, The Irish Legal System, 2nd ed. Ed., Butterworths
  • McMahon & Binchy 1990, Irish Law of Torts, Butterworth (Ireland) Ltd
This module does not have any article/paper resources
This module does not have any other resources