Pharmaceuticals: Compliance and Audits

Supplementary Materials

Table of Contents
Tips and Best Practices ................................................................................................................................... 1
Acronyms Guide.............................................................................................................................................. 2
References and Resources .............................................................................................................................. 4
Course Storyboard .......................................................................................................................................... 6

TIPS AND BEST PRACTICES

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system to help maximize and simplify your learning experience. It is also a good idea to read the Online University FAQs accessible in the HELP section.
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organizational tool for your own note-taking and not the full course text; printable full text is not available. Some of the Storyboard images may appear
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TAKING THE FINAL ASSESSMENT
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RAPS Online University | Pharmaceuticals: Compliance and Audits

ACRONYMS GUIDE
ADE
ADR
AE
ANDA
API
ARTG
BGTD
BIMO
BLA
CAPA
CAR
CAT
CBER
CDER
CDRH
CFR
CFR
CFSAN
CGMP
CHMP
CMC
CP
CPP
CQA
CRO
CTA
CVMP
DEA
DMF
DMPQ

Adverse Drug Events

Adverse Drug Reaction
Adverse Events
Abbreviated New Drug Application
Active Pharmaceutical Ingredient
Australian Register of Therapeutic Goods
Biologics and Genetic Therapies Directorate
Bioresearch Monitoring Program
Biologic License Applications
Corrective and Preventive Actions
Corrective Action Requests
Committee for Advanced Therapies
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Code of Federal Regulations
Code of Federal Regulations
Center for Food Safety and Applied Nutrition
Current Good Manufacturing Practices
Committee for Medicinal Products for Human Use
Chemistry, Manufacturing and Controls
Compliance Program
Critical Process Parameters
Critical Quality Attributes
Contract Research Organizations
Clinical Trial Application
Committee on Medicinal Products for Veterinary Use
Drug Enforcement Agency
Document Master File
Division of Manufacturing and Product Quality

RAPS Online University | Pharmaceuticals: Compliance and Audits

DOD
DQR
EC
EEA
EFPIA
EFTA
EIR
EMA
EN
EPA
EV
FD&C Act
FDA
FDAAA
FDAMA
FDLI
GAO
GCP
GDP
GLP
GMP
GMP
HC
HHS
HIPAA
HMA
HPFBI
ICH
IFPMA

Department of Defense
Drug Quality Reports
European Commission
European Economic Area
European Federation of Pharmaceutical Industries and
Associations
European Free Trade Association
Establishment Inspection Report
European Medicines Agency
European Standards
Environmental Protection Agency
Effectiveness Verification
Food, Drug and Cosmetic Act
US Food and Drug Administration
Food and Drug Administration Amendments Act
Food and Drug Administration Modernization Act
Food and Drug Law Institute
Government Accountability Office
Good Clinical Practice
Good Distribution Practice
Good Laboratory Practice
Good Manufacturing Practice (US)
Good Manufacturing Principle (Australia)
Health Canada
US Department of Health and Human Services
Health Insurance Portability and Accountability Act
Heads of Medicines Agencies
Health Products and Food Branch Inspectorate
International Conference on Harmonization
International Federation of Pharmaceutical
2

IND
IOM
IRC
ISO
ITF
JAAME
JPMA
MAA
MAH
MHLW
MOU
MRA
NAI
NDA
NDS
NGO
NiBio
NIHS
NME
OECD
OMQ
OOS
OPSR
ORA
OSHA
OTC
PAI
PAL
PAT
PDMA

Manufacturers & Associations

Investigational New Drugs
Investigations Operations Manual
International Regulatory Cooperation
International Organization for Standardization
Innovation Task Force
Japan Association for the Advancement of Medical
Equipment
Japan Pharmaceutical Manufacturers Association
Marketing Authorization Application
Marketing Authorization Holder
Japanese Ministry of Health, Labour and Welfare
Memorandum of understanding
Mutual Recognition Agreement
No Action Indicated
New Drug Application
New Drug Submission
Non-Governmental Organization
National Institute of Biomedical Innovation
National Institute of Health Sciences
New Molecular Entities
Organization for Economic Cooperation and Development
Office of Manufacturing Quality
Out-of-Specification
Organization for Pharmaceutical Safety and Research
Office of Regulatory Affairs
Occupational Safety and Health Administration
Over-the-Counter
Pre-Approval Inspection
Pharmaceutical Affairs Law
Process Analytical Technology
Prescription Drug Marketing Act

RAPS Online University | Pharmaceuticals: Compliance and Audits

PhRMA
PIC/S
PMDA
PMDEC
PPE
QMS
QP
QRB
QS
QSR
SMON
SOX
SPC
TGA
TPD
UL
US
USDA
USP
VAI
WHO

Pharmaceutical Research and Manufacturers of America

Pharmaceutical Inspection Cooperation Scheme
Pharmaceuticals and Medical Devices Agency
Pharmaceuticals and Medical Devices Evaluation Center
Personal Protective Equipment
Quality Management Systems
Qualified Person
Quality Review Board
Quality System
Quality System Regulation
Subacute Myelo-Optical-Neuropathy
Sarbanes-Oxley
Statistical Process Control
Therapeutic Goods Administration
Therapeutics Products Directorate
Underwriters Laboratories
United States
US Department of Agriculture
United States Pharmacopeia
Voluntary Action Indicated
World Health Organization

REFERENCES AND RESOURCES

Lesson 1
EMA. Committee for Medicinal Products for Human Use (CHMP) website.
European Medicines Agency (EMA) website.
Heads of Medicine Agencies (HMA) website.
Ministry of Health, Labour and Welfare. (4) Drugs - Approval and Licensing System for Drugs, Quasi-drugs and Cosmetics
National Institute of Health Sciences website.
Pharmaceutical Inspection Cooperation Scheme.
Pharmaceuticals and Medical Devices Agency (PMDA) website.
TGA. Australian register of therapeutic Goods (ARTG) website.
TGA. Office of Manufacturing Quality.
Therapeutic Goods Administration (TGA) website.
US FDA. CP 7346.832CP 7346.832Pre-approval Inspections/Investigations. 5 April 2005.
US FDA. CP 7346.843CP 7346.843 Postapproval Audit Inspections.
US FDA. CP 7356.002CP 7356.002 Drug Manufacturing Inspections. 1 February 2002.
US FDA. Remarks by Margaret A. Hamburg, M.D. Commissioner of Food and Drugs on "Effective Enforcement and Benefits to Public Health-Effective Enforcement and Benefits to Public Health" at Food and Drug Law Institute. 6 August 2009.
Lesson 2
7356.002M, Inspections of Licensed Biological Therapeutic Drug Products
Chesney, David L. Management Controls for GMP Compliance Pharmaceutical Technology April 2005. P 64-72
Compilation of Community Procedures on Inspections and Exchange of Information: Guideline on Training and Qualifications of GMP Inspectors
(Compliance and Inspection). European Medicines Agency. EMA/INS/GMP/321252/2012 Rev 14. 25 May 2012. Page 55-60.
Conan-Conan, Michelle. [October 2011] EMA-FDA Joint GMP and GCP Inspection Pilot Programs
Dodsworth, N; Hubby S. Global Forum. Comparison between the FDA and European Inspection Process: Joint EMA-FDA GCP Inspections.
FDA. CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections. 2 June 2007.
FDA. Investigations Operations Manual.
FDA - TGA
FDA's Pharmaceutical Inspectorate Searches for Higher Ground, Thomas, P. Pharma Manufacturing
FDA's Pharmaceutical Inspectorate. Robert Coleman. National Expert Drug Investigator. Food and Drug Administration. Certification.
Background. Certification ... asq.org/fdc/2006/02/fda-s-pharmaceutical-inspectorate.ppt
GMP Inspection Cooperation between EMA and FDA
GMP Inspection Cooperation between Canada Health Protection Branch and FDA
GMP Inspection Cooperation between Japan and FDA
RAPS Online University | Pharmaceuticals: Compliance and Audits

ISO 9001:2008. Quality Management Systems Requirements.

ISO 9000:2001 Quality Management Systems Requirements.
Nazar, N., Schmidt, S. RA Focus Oct. 2011. Vol 16, No. 10 p. 23-28.
PIC/S BLUEPRINT (Road Map 2015): PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME. PS/W 8/2005. 23 December 2005
US Department of Health & Human Services. HIPAA Enforcement.
Writing An Effective 483 Response, Anita Richardson FDA

General Resources
Agrasala, Vinod. Assessment, Gap analysis and Audit!
American Society for Quality. Quality Auditor Certification - Body of Knowledge.
Boatman, J. QPharma. Introduction to Life Science Auditing. 2010.
Deloitte. The Risk Intelligent chief audit executive - Mission possible. Risk Intelligence Series Issue No. 5.
FDA. 21 CFR Part 820 - Quality System Regulation.
FDA. Final Guidance for Industry and FDA Staff - General Principles of Software Validation. 11 January 2002.
FDA. Guidance for Industry - Part 11, Electronic Records; Electronic Signatures Scope and Application. August 2003.
FDA. Hazard Analysis and Critical Control Point Principles and Application Guidelines.
FDA. Inspection Reference, Guides & Field Activities.
FDA. Pharmaceutical CGMPs for the 21st Century - A Risk-Based Approach. September 2004.
FDA. The FDA Enforcement Report.HIMA. Points to Consider When Preparing for an FDA Inspection under the Management Controls Subsystem.
6 October 1999.
ICH. Q9 Quality Risk Management
Institute of Internal Auditors. Practice Advisory 2010-2: Using the Risk Management Process in Internal Audit Planning, July 2009.
Institute of Internal Auditors. The Role of Internal Auditing in Enterprise-wide Risk Management. 29 September 2004.
International Society for Pharmaceutical Engineering. GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. 2008. RAPS.
Fundamentals of EU Regulatory Affairs, 4th Edition.
Rolli, Nancy. FDA. Role of Internal Auditing in GMP Management. Presented 14 May 2008.
Swann, John P. FDAs Origin. 18 June 2009.
Wilkenfeld, Jonathan. Rx Compliance Report. 7 September 2009.

RAPS Online University | Pharmaceuticals: Compliance and Audits

COURSE STORYBOARD

RAPS Online University | Pharmaceuticals: Compliance and Audits

Course Overview

Notes:

Learning Objectives

Notes:

RAPS Online University | Pharmaceuticals: Compliance and Audits

Author Biographies

Notes:

References and Resources

Notes:

RAPS Online University | Pharmaceuticals: Compliance and Audits

Lesson 1: Pharmaceutical
Drug Compliance

Notes:

Introduction

Notes:

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Lesson Objectives

Notes:

History of FDA

Notes:

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FDAs Recent Enforcement

Initiatives

Notes:

FDAs Current Initiatives

Notes:

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Compliance Programs

Notes:

Preapproval
Inspections/Investigations
Compliance Program
7346.832

Notes:

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Preapproval Inspection
(PAI) Program Objectives

Notes:

Objective 1: Readiness for

Commercial
Manufacturing

Notes:

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Objective 1(a)

Notes:

Objective 1(b)

Notes:

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Objective 1(c)

Notes:

Objective 1(d)

Notes:

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Objective 1(e)

Notes:

Objective 2: Conformance
to Application

Notes:

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Objective 3: Data Integrity

Audit

Notes:

Postapproval Audit
Inspections: Compliance
Program 7346.843

Notes:

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Types of Inspections

Notes:

Strategy for Inspections

Notes:

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Audit Process

Notes:

Drug Manufacturing
Inspections: Compliance
Program 7356.002

Notes:

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Scheme of Systems

Notes:

Inspection Approaches

Notes:

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Comprehensive Inspection
Coverage

Notes:

FDA Enforcement Actions

Notes:

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FDA Enforcement Report

Notes:

Enforcement Report
Definitions

Notes:

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Current International
Regulatory Body
Compliance Enforcement
Initiatives

European Union (EU)

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Notes:

23

The Heads of Medicines

Agencies

Notes:

The European Medicines

Agency

Notes:

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Good Laboratory Practice

Notes:

Good Manufacturing
Practice

Notes:

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Good Distribution Practice

Notes:

Role of the Compliance

and Inspection Sector

Notes:

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GMP Advice

Notes:

Innovation Task Force (ITF)

Notes:

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GLP Inspections

Notes:

Laboratories Performing
Nonclinical Safety Studies

Notes:

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Guidance Related to GCP

Implementation

Notes:

Mutual Recognition
Agreements

Notes:

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Canada

Notes:

Health Canada

Notes:

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Good Clinical Practice

Notes:

Japan

Notes:

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Japan

Notes:

GMP Compliance
Inspection of Foreign
Manufacturers

Notes:

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GMP Inspection for

Approval

Notes:

Scope of Drugs Subject to

GMP Compliance
Inspection

Notes:

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Inspection Application
Documents

Notes:

Inspection Fee

Notes:

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The Pharmaceuticals and

Medical Devices Agency

Notes:

Australia

Notes:

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Australia

Notes:

Therapeutic Goods

Notes:

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Control of Therapeutic
Goods

Notes:

Office of Manufacturing
Quality

Notes:

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Lesson Summary

Notes:

Lesson 2: Pharmaceutical
Drug Audits

Notes:

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Introduction

Notes:

Lesson Objectives

Notes:

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US Pharmaceutical Drug
Inspections

Notes:

What is an Inspection?

Notes:

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Investigations Operations
Manual

Notes:

Establishment Inspections

Notes:

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Pre-announcements

Notes:

Coordinating an
Inspection

Notes:

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Notice of Inspection

Notes:

Considerations During an
FDA Inspection

Notes:

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Inspection Walk-through

Notes:

Inspectional Approach

Notes:

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System Inspection
Coverage

Notes:

FDA Access to Records

Notes:

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Closing Meetings and

Reporting of Observations

Notes:

FDA Authority to Issue 483

Notes:

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Difference Between a
Form 483 and a Warning
Letter?

Notes:

FDA Activities Following

an Inspection

Notes:

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Responding to a Form 483

/ Warning Letter

Notes:

Drafting a Form
483/Warning Letter
Response

Notes:

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Additional Governing
Agencies, Acts, Standards
and Organizations

Notes:

General Discussion on
International Market
Audit Requirements

Notes:

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Memoranda of
Understanding and Other
Cooperative
Arrangements

Notes:

GMP Inspection
Cooperation between the
US, Canada, Australia and
Japan

Notes:

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International Guidance for

Training and Qualification
of GMP Inspectors

Notes:

EU

Notes:

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Maintenance of
Competence

Notes:

US: Training of Inspectors

Notes:

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What is the curriculum?

Notes:

The Pharmaceutical
Inspection Convention
(PIC/S)

Notes:

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Pharmaceutical
Inspectorate as part of
PIC/S

Notes:

Joint Audit Program

Notes:

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Lesson Summary

Notes:

Lesson 3: Auditing
Techniques and Tools

Notes:

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Introduction

Notes:

Lesson Objectives

Notes:

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Auditing as a Value
Proposition

Notes:

Types of Audits

Notes:

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Effectiveness Verification

Notes:

ISO 9000

Notes:

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ISO 19011: General

Guidelines for Quality
and/or Environmental
Management Systems
Auditing

Notes:

Auditor Independence

Notes:

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Auditing to a Standard or
Regulation

Notes:

The Process Approach

Notes:

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Other Approaches

Notes:

Preparing and Using an

Audit Checklist

Notes:

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Note-taking

Notes:

Questioning Techniques

Notes:

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Preparing to Audit

Notes:

The Opening Meeting

Notes:

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The Tour

Notes:

Audit Execution

Notes:

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Evidence/Records

Notes:

Closing Meeting

Notes:

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Audit Findings

Notes:

Types of
Nonconformances

Notes:

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Objective Evidence

Notes:

Documentation

Notes:

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Common Mistakes

Notes:

Lesson Summary

Notes:

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68

Closing Summary

Notes:

Proceed to Final
Assessment

Notes:

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