Welcome Guest
  |   0 items in your shopping cart
 

BROWSE BY STANDARDS

BROWSE BY CATEGORY

***
 
 
Join our mailing list to recieve newsletters
 

The Certified Pharmaceutical GMP Professional Handbook, 2nd Edition

Send to friend
 
Title: The Certified Pharmaceutical GMP Professional Handbook, 2nd Edition
Author: Mark Allen Durivage
ISBN: 8174890491 / 9788174890498
Format: Hard Cover
Pages: 516
Publisher: ASQ/Infotech
Year: 2017
Availability: In Stock
Special Indian Edition Priced at Rs.1695/-. FREE Shipping within India. Delivery : Within 2 to 4 working days.
     
 
  • Description
  • Contents

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.

List of Figures and Tables
Acronyms and Abbreviations
Preface
Acknowledgments

Part I : Regulatory Agency Governance
Chapter 1 :
Global Regulatory Framework
Chapter 2 : Regulations and Guidances
Chapter 3 : Mutual Recognition Agreements
Chapter 4 : Regulatory Inspections
Chapter 5 : Enforcement Actions
Chapter 6 : Regulatory Agency Reporting
Chapter 7 : Site Master File (SMF), Validation Master Plan (VMP), Drug Master File (DMF), and Site Reference File (SRF)

Part II : Quality Systems
Chapter 8 :
Quality Management System
Chapter 9 : Quality Unit (Site) Management
Chapter 10 : Risk Management
Chapter 11 : Training and Personnel Qualifications
Chapter 12 : Change Control and Management
Chapter 13 : Investigations and Corrective and Preventive Action (CAPA)
Chapter 14 : Audits and Self-Inspections
Chapter 15 : Documents and Records Management
Chapter 16 : Product Quality Complaints and Adverse Event Reports
Chapter 17 : Product Trend Requirements
Chapter 18 : Supplier and Contractor Quality Management

Part III : Laboratory Systems
Chapter 19 :
Compendia (US, Europe, and Japan)
Chapter 20 : Laboratory Investigations of Atypical Results
Chapter 21 : Instrument Management
Chapter 22 : Specifications
Chapter 23 : Laboratory Record-Keeping and Data Requirements
Chapter 24 : Laboratory Handling Controls
Chapter 25 : Stability Programs
Chapter 26 : Reserve Samples and Retains

Part IV : Infrastructure : Facilities, Utilities, Equipment
Chapter 27 :
Facilities
Chapter 28 : Cleanrooms
Chapter 29 : Utilities
Chapter 30 : Equipment
Chapter 31 : Qualification and Validation
Chapter 32 : Maintenance and Metrology Systems
Chapter 33 : General Cleaning, Sanitization, and Pest Control
Chapter 34 : Automated or Computerized Systems
Chapter 35 : Societal Security - Business Continuity Management Systems

Part V : Materials Management and Supply Chain
Chapter 36 :
Receipt of Materials
Chapter 37 : Sampling Processes
Chapter 38 : Material Storage, Identification, and Rotation
Chapter 39 : Shipping and Distribution
Chapter 40 : Traceability and Sourcing
Chapter 41 : Salvaged/Returned Goods and Destruction

Part VI : Sterile and Nonsterile Manufacturing Systems
Chapter 42 :
Master Batch and Completed Batch Records
Chapter 43 : Production Operations
Chapter 44 : In-Process Controls
Chapter 45 : Dispensing and Weighing Controls
Chapter 46 : Requirements for Critical Unit Processes
Chapter 47 : Contamination and Cross-Contamination
Chapter 48 : Reprocessed and Reworked Materials

Part VII : Filling, Packaging, Labeling
Chapter 49 :
Filling Operations and Controls
Chapter 50 : Environmental Monitoring
Chapter 51 : In-Process and Finished Goods Inspections
Chapter 52 : Product Inspection
Chapter 53 : Packaging Operations and Controls
Chapter 54 : Labeling Operations and Controls
Chapter 55 : Filling and Packaging Records

Part VIII : Product Development and Technology Transfer
Chapter 56 :
Quality by Design Concepts
Chapter 57 : Phase-Appropriate GMP Requirements
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

Appendix A : At-a-Glance Comparions
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

 
 
 
About Us | Contact us
loading...
This page was created in 0.2857129573822 seconds