The Certified Pharmaceutical GMP Professional Handbook 2nd Edition by Mark Allen Durivage, ISBN-13: 978-0873899338

Description

The Certified Pharmaceutical GMP Professional Handbook 2nd Edition by Mark Allen Durivage, ISBN-13: 978-0873899338

[PDF eBook eTextbook] – Available Instantly

• Publisher: ‎ ASQ Quality Press; Second edition (May 26, 2016)
• Language: ‎ English
• 516 pages
• ISBN-10: ‎ 0873899334
• ISBN-13: ‎ 978-0873899338

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.

This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Table of Contents:

Title Page

CIP Data

Table of Contents

List of Figures and Tables

Acronyms and Abbreviations

Preface

Acknowledgments

Part I: Regulatory Agency Governance

Chapter 1: Global Regulatory Framework

United States Federal Statutes Relevant to Pharmaceuticals

The Administrative Procedure Act

United States Federal Food, Drug, and Cosmetic Act

United States Public Health Service Act

The Virus-Serum-Toxin Act

European Union’s Legal System Relevant to Pharmaceuticals

Japan’s Legal System Relevant to Pharmaceuticals

China’s Legal System Relevant to Pharmaceuticals

India’s Legal System Relevant to Pharmaceuticals

Chapter 2: Regulations and Guidances

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Health Canada

World Health Organization (WHO)

International Conference on Harmonization

European Medicines Agency (EMA)

The United States Food and Drug Administration

Therapeutic Goods Administration (TGA)

United States Department of Agriculture (USDA) 9 CFR—Animals and Animal Products

USDA Veterinary Service Memorandum No. 800.65

International Pharmaceutical Excipients Council

Japanese Ministry of Health, Labour, and Welfare (MHLW)

Chapter 3: Mutual Recognition Agreements

Mutual Recognition Agreements

MRAs Established by the European Union and Partner Countries

Key Elements of Mutual Recognition Agreements

Pharmaceutical Inspection Co-operation Scheme

Chapter 4: Regulatory Inspections

Inspection Authority

Types of Inspections

Sharing of Inspection Findings

Inspections of Foreign Drug Manufacturers

Reviewing Documents

Validation

Cultural Aspects

Documentation of Violations of cGMPs

Inspection Techniques

Inspection Process of a U.S. Firm

Chapter 5: Enforcement Actions

Types of Enforcement Actions

Notice of Observations/Violations

FDA Untitled Letters

Warning Letters

Product Seizures

Injunctions

Loss of Marketing License

Loss of Establishment License

Debarment

Voluntary Actions

Chapter 6: Regulatory Agency Reporting

Planned Changes

Evaluating Post-Marketing Changes

Technical Assessment

Analytical Assessment

Equivalence Assessment

Adverse Effect

Reporting Strategy

Regulatory Reporting Requirements

Planned Changes

Unplanned Events

Chapter 7: Site Master File (SMF), ValidationMaster Plan (VMP), Drug Master File(DMF), and Site Refe

Site Master File

Content of Site Master Files

Validation Master Plan (VMP) and Master Validation Plan (MVP)

Drug Master File

Types of Drug Master Files

Changes to Drug Master Files

Preparing a Site Master File (SMF)

Content of Site Master File

Appendixes

Part II: Quality Systems

Chapter 8: Quality Management System

Establishing a Quality Management System

Quality Management System Principles

Quality Management System Practices

Audits, Reviews, and Assessments

ICH Q10: Pharmaceutical Quality System

ICH Q10 Objectives

Enablers: Knowledge Management and Quality Risk Management

Design and Content Considerations, Quality Manual

Management Responsibility

Management Commitment

Quality Policy

Quality Planning

Resource Management

Internal Communication

Management Review

Management of Outsourced Activities and Purchased Materials

Management of Change in Product Ownership

Continual Improvement of Process Performance and Product Quality

Life Cycle Stage Goals

Pharmaceutical Quality Management System Elements

Continual Improvement of the Pharmaceutical Quality System

Management Review

Monitoring of Internal and External Factors

Outcomes of Management Review and Monitoring

Conclusion

Chapter 9: Quality Unit (Site) Management

Qualified Person

Responsibilities of the Qualified Person

Specific Requirements for the Qualified Person

Certification of Batch Release

Maintenance of a Quality Management System

The Qualified Person and the Product Quality Review

The Qualified Person and Reference and Retention Samples

External Qualified Persons

Delegation of Tasks/Absence of a Qualified Person

Organizational Duties to Be Established by the Companyof the Qualified Person

Annex 16 to the EU Guide to GMP Certification and Batch Release

Principle

Introduction

General

Batch Testing and Release of Products Manufactured in the EC/EEA

Batch Testing and Release of Products Imported from a Third Country

General

Location of Sampling for Testing in EC/EEA

Batch Testing and Release of Products Imported from a Third Country with EC MRA

Routine Duties of a Qualified Person

Chapter 10: Risk Management

General Quality Risk Management Process

Risk Assessment

Risk Control

Risk Communication and Risk Review

Risk Management Methodology

Integration into Industry and Regulatory Operations

Methods and Tools

Basic Risk Management Facilitation Methods

Failure Mode and Effects Analysis

Failure Mode, Effects, and Criticality Analysis

Fault Tree Analysis

Hazard Analysis and Critical Control Points

Hazard Operability Analysis

Preliminary Hazard Analysis

Risk Ranking and Filtering

Supporting Quality and Statistical Tools

Chapter 11: Training and Personnel Qualifications

Job-Specific Training

Good Manufacturing Practices Training

Training Effectiveness

Employee Qualifications

Documentation of Training

Employee Proficiency

Chapter 12: Change Control and Management

Chapter 13: Investigations and Corrective and Preventive Action (CAPA)

CAPA Process

General Considerations for CAPA

CFR 211.192 Production Record Review

FDA 21 CFR 820.100 Corrective and Preventive Action

FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

FDA Guide to Inspections of Quality Systems

Chapter 14: Audits and Self-Inspections

Audit Types

First-Party Audits

Audit Process

Written Procedure

Audit Schedule

Qualified, Independent Auditors

Analyze Audit Results to Assess Conformance to Requirements

Documentation of Findings and Corrective Actions

Management Responsibility for Implementation of Corrective Actions

Verification of Corrective Actions

Chapter 15: Documents and Records Management

Documentation Hierarchy

Documents and Records

Good Documentation Practices

Master Documents

Executed Documents

GMP Records

Training Records

Facility Records

Material Receipts

Batch Records

Log Books

Complaint Records

Records Management

Record Retention

Litigation Concerns

Chapter 16: Product Quality Complaints and Adverse Event Reports

Importance of Post-Market Surveillance and Reporting

Building an Effective Complaint Management System

Adverse Event Reporting—FAERS

Differences between Compaints and Adverse Events

Keys to Compliance

Chapter 17: Product Trend Requirements

Regulations

Annual Product Reviews

General Requirements

Data Elements

Product Quality Reviews

General Requirements

Data Elements Mandated by EU Regulations

Additional Considerations

Chapter 18: Supplier and Contractor Quality Management

Requirements for Materials and Services

On-Site Audit

Quality System Survey

Change Control

Trending

Supplier Certification

Supply Chain Considerations

Registration, Evaluation, Authorization, and Restriction of Chemicals (REACh)

Restriction of Hazardous Substances (RoHS)

Conflict Minerals

Animal Tissue

Counterfeit Medicine and Medicinal Components

Part III: Laboratory Systems

Chapter 19: Compendia (US, Europe, and Japan)

Analytical Tests

Chapter 20: Laboratory Investigations of Atypical Results

Regulatory Guidance

Analytical Error

Conducting an OOS Investigation

Analytical OOS Investigations

Full-Scale OOS Investigation

Production Review

Reporting Testing Results

Concluding the Investigation

Interpretation of Investigation Results

Microbiology OOS Investigations

Standard Operating Procedures and Protocol

Identification (Speciation) of the Organism

Record of Laboratory Tests and Deviations

Monitoring of Production Area Environment

Monitoring Personnel (Laboratory and Production)

Product Bioburden

Production Record Review

Manufacturing History (Including Media Fills Where Applicable)

API Source

Excipients

Satellite Facilities

Contract Laboratories

Case Study

Objectionable Microorganisms

Absolute Number of Organisms Seen

The Characteristics of the Microorganism

Product Characteristics

Route of Administration

Patient Population

Chapter 21: Instrument Management

Chapter 22: Specifications

Development of Specifications

Criteria for Establishing Specifications

Raw Material Specifications

Drug Substances

Inactive Ingredients (Excipients)

Intermediates

Packaging Components

Finished Drug Product

Finished Product Specifications

Acceptance Limits for Excipients

Additional Considerations

Specification Revision

Chapter 23: Laboratory Record-Keeping and Data Requirements

Significant Digits and Rounding

Rules for Significant Digits/Figures

Maintaining Significant Digits in Calculations

Rounding with Significant Figures

Chapter 24: Laboratory Handling Controls

Incoming Material Receipt, Inspection, and Sampling

Samples for Products Manufactured In-House

Stability Samples

Reagents or Solutions

Calibration and Laboratory Standards

Sample Storage

Reagents or Solutions

Analytical Standards

Chapter 25: Stability Programs

Types of Stability Studies

Product Development Stability

Commercial Support Stability

Change Management Stability

Execution of Stability Studies

Conditions

Time Points

Packaging Configurations

Accelerating Studies

Chapter 26: Reserve Samples and Retains

Part IV: Infrastructure: Facilities, Utilities, Equipment

Chapter 27: Facilities

Introduction

Design and Construction Features (21 CFR 211.42)

Lighting (21 CFR 211.44)

Ventilation, Air Filtration, Air Heating and Cooling (21 CFR 211.46)

Plumbing (21 CFR 211.48)

Sewage and Refuse (21 CFR 211.50)

Washing and Toilet Facilities (21 CFR 211.52)

Sanitation (21 CFR 211.56)

Maintenance (21 CFR 211.58)

Chapter 28: Cleanrooms

Specific ISO Sections Related to Cleanrooms

ISO 14644-2:2000

ISO 14644-1:1999

ISO 14644-2:2000

ISO 14644-3:2005

ISO 14644-4:2001

ISO 14644-5:2004

ISO 14644-6:2007

ISO 14644-7:2004

ISO 14644-8:2013

ISO 14644-9:2012

ISO 14698-1:2003

ISO 14698-2:2003

Cleanroom Operation

Cleanroom Personnel

Gowning and Hygiene

Glove Donning Techniques

Sources of Contamination

Gowning Recommendations

Chapter 29: Utilities

Chapter 30: Equipment

Design

Materials of Construction

Lubricants

Equipment Layout

Equipment Cleaning Validation

GMP of Cleaning Validation and Analytical Methods

Cleaning Validation and Sampling, Rinsing, Rinse Samples, and Detergents

Establishment of Cleaning Validation Limits

Documentation

Equipment Cleaning

Maintenance

Equipment Change Control

Chapter 31: Qualification and Validation

Introduction

Validation Master Plan (VMP) and Master Validation Plan (MVP)

Design Qualification

Commissioning and Qualification

Installation Qualification

Operational Qualification

Performance Qualification

Process Validation

Validation Life Cycle

Chapter 32: Maintenance and Metrology Systems

Measurement Systems Analysis (MSA) or Test Method Validation (TMV)

Chapter 33: General Cleaning, Sanitization, and Pest Control

Washing Facilities and Cleaning Procedures

Sanitization Procedures

Literature Efficacy of Various Sanitizers

Pest Control

Chapter 34: Automated or Computerized Systems

System Life Cycle

Validation and Qualification

Regulatory References

Open and Closed Systems

Change Management

Testing Changes

Chapter 35: Societal Security—Business Continuity Management Systems

An Overview of ISO 22301:2012

The PDCA Approach

Brief Overview of Key Clauses of ISO 22301:2012 Business Continuity Standard

Clause 4: Context of the Organization

Clause 5: Leadership

Clause 6: Planning

Clause 7: Support

Clause 8: Operation

Clause 9: Performance Evaluation

Clause 10: Improvement

Part V: Materials Management and Supply Chain

Chapter 36: Receipt of Materials

Incoming Inspection

Identification and Labeling of Starting Materials

API GMP for Receipt of Materials

Chapter 37: Sampling Processes

General Sampling Requirements

Sampling Facilities, Utensils, and Equipment

Sample Containers and Labeling

Training of Personnel

Sampling of Starting Materials for API Manufacturing

Sampling of Packaging Materials

Chapter 38: Material Storage, Identification, and Rotation

Material Storage

Material Identification

Stock Rotation and Control

Control of Obsolete and Outdated Materials and Products

Chapter 39: Shipping and Distribution

Chapter 40: Traceability and Sourcing

Traceability

Raw Materials and Components

Product Manufacturing and Packaging

Finished Dosage Form

Distribution Records

Biological Agents

Pharmaceutical Supply Chain

Chapter 41: Salvaged/Returned Goods and Destruction

Returned Drug Products

Salvaged Drug Products

Disposal of Drug Products

Part VI: Sterile and Nonsterile Manufacturing Systems

Chapter 42: Master Batch and Completed Batch Records

Issuance

Yield

Critical Step Verification

Processing Instructions

Hold Times

Completed Batch Records

Review and Disposition of PBR

Chapter 43: Production Operations

General

Process Validation

Application Factors

Human Drugs

Nonsterile Manufacturing and Manufacturing of Liquids, Creams, and Ointments

Sanitization and Protection

Gowning Requirements

Sanitization and Hygiene

Chapter 44: In-Process Controls

21 CFR 211.110 and Eudralex Volume 4

21 CFR 211.110(b) Appropriate Written Procedures

21 CFR 211.110(c) In-Process Material Testing

21 CFR 211.110(d) Rejected In-Process Materials

FDA Guidance—Powder Blends and Finished Dosage Units

Time Limits

Microbiological Contamination

Contamination Control

21 CFR 211.115 Reprocessing

Combination Products

Biotechnology Products

Viral Clearance

Inactivation

Manufacturing and Aseptic Processing

Lyophilization

Chapter 45: Dispensing and Weighing Controls

Weighing Equipment

Dispensing Utensils

Staging Areas

Weigh Room

Weighing Process

Audit

Chapter 46: Requirements for Critical Unit Processes

Hazard Analysis and Critical Control Points (HACCP)

Hazard Analysis

Critical Control Point Identification

Establishment of Critical Limits

Monitoring Procedures

Corrective Actions

Record Keeping

Verification Procedures

Good Manufacturing Practices

Chapter 47: Contamination and Cross-Contamination

Introduction

Warning Letter Citations

Causes of Contamination and Cross-Contamination

Methods for Preventing Contamination and Cross-Contamination

Equipment Cleaning

Equipment-Related Parameters

Residue Removal

Cleaning Agents

Cleaning Processes

Process Variables

Proper Identification and Labeling

Line Clearance

Summary

Chapter 48: Reprocessed and Reworked Materials

Reprocessing

Reworking

Part VII: Filling, Packaging, Labeling

Chapter 49: Filling Operations and Controls

Materials Control

Filling Assembly Procedures

Filling Equipment Controls

Contamination Controls

Staged Materials

Status Labeling

Chapter 50: Environmental Monitoring

Nonviable Particle Monitoring

Contact Plates

Swab Monitoring

Settle Plates

Active (Viable) Air Monitoring

Chapter 51: In-Process and Finished Goods Inspections

Inspection Methodologies

Visual Inspection

Seal Quality Inspection (Airborne Ultrasound)

Nondestructive Leak Testing (Vacuum Decay)

Bubble Emission Testing

Blister Package Inspection and Container Leak Testing

Burst Testing

Creep Testing

Dye Penetration

Freeze-Dried Product Leak Testing

Automated Vision Inspection Systems

Qualification and Calibration

Chapter 52: Product Inspection

Manual Visual Inspection

Training

Qualification

Chapter 53: Packaging Operations and Controls

Content Protection

Types of Plastics Used for Pharmaceutical Packaging

Types of Glass Used for Pharmaceutical Packaging

Packaging Operation Controls

The Packaging Line

Chapter 54: Labeling Operations and Controls

Label Receipt

Labeling Issuance to Manufacturing

Label Quality and Label Operations

Expiration Dating

Artwork Development and Controls

Printing Process

Vendor Proof

Gang Printing

Roll Label Splicing

Off-Line Printing

Secure Storage of Labeling

Destruction of Labeling

Control of Graphical Files and Printing Plates

Examples of FDA Warning Letters

Other Examples of FDA Warning Letters

Chapter 55: Filling and Packaging Records

Regulations and Guidance Documents

Filling and Packaging Records

Production, Process Control, and Laboratory Record Review

Part VIII: Product Development and Technology Transfer

Chapter 56: Quality by Design Concepts

Quality by Design

Critical Process Parameter

Critical Quality Attributes

Design Space

Validation Principles with Quality by Design

Process Analytical Technology Tools

Multivariate Tools

Process Analytical Technology

Process Control Tools

Control Charts

Continuous Improvement and Knowledge Management Tools

Chapter 57: Phase-Appropriate GMP Requirements

Clinical Trials

Observational Studies

Participating in a Clinical Study

Informed Consent

Institutional Review Boards

Combination Products

Investigational Products

Change Control

Chapter 58: Raw Materials, Packaging, and Infrastructure for Product Development

Chapter 59: New Product Development Studies and Reports

Chapter 60: Scale-up and Transfer Activities

Development and Validation Reports

Technology Transfer Types

Process Development and Characterization Studies

Process Ranging Studies

Process Capability Studies

In-Process Control Studies

Hold-Time Studies

Physico-Mechanical Simulations and Shipping Studies

Appendix A: At-a-Glance Comparisons

Appendix B: 21 CFR 211 Pharmaceuticals GMP Overview

Appendix C: 21 CFR 820 Medical Device GMP Overview

Appendix D: Body of Knowledge—Pharmaceutical GMP Professional Certification (CPGP)

Glossary

References and Suggested Reading

Index

What makes us different?

• Instant Download

• Always Competitive Pricing

• 100% Privacy

• FREE Sample Available

• 24-7 LIVE Customer Support