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Pharmaceutical Manufacturing Handbooks
from C.H.I.P.S.

Pharmaceutical Manufacturing Handbook
Regulations and Quality
edited by
Shayne Cox Gad

Pharmaceutical Manufacturing Handbook: Regulations and Quality contains everything you need to ensure full compliance and superior quality control!

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing.

In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines.

Among the key topics covered are:

  • Enforcement of current good manufacturing practices
  • Inspections by health regulatory agencies
  • Creating and managing a quality management system
  • Personnel training within pharmaceutical manufacturing
  • Microbiology of non-sterile pharmaceutical manufacturing
  • Pharmaceutical manufacturing validation principles

Following the handbook's carefully developed guidelines and advice will help ensure full compliance and avoid potential costly pitfalls. This publication should be readily accessible to all scientists, engineers, and managers involved in pharmaceutical manufacturing.

Contents

Section 1: Good Manufacturing practices (GMP) and Other FDA Guidelines

  • Good Manufacturing Practices (GMPs) and Related FDA Guidelines
  • Enforcement of Current Good Manufacturing Practices
  • Scale-Up and Postapproal Changes (SUPAC) Regulations
  • GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells

Section 2: International Regulations of Good Manufacturing Practices

  • National GMP Regulations and Codes and international GMP Guides and Guildelines: Correspondences and Differences

Section 3: Quality

  • Analytical and Computational Methods and Examples for Designing and Controlling total Quality Management Pharmaceutical Manufacturing systems
  • Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment
  • Creating and Managing a Quality Management system
  • Quality process improement

Section 4: Process Analytical Technolgoy (PAT)

  • Case for Process Analytical Technology: Regulatory and Industrial Perspectives
  • Process Analytical Technology
  • Chemical imaging and Chemometrics: Useful Tools for Process Analytical Technology

Section 5: Personnel

  • Personnel Training in Pharmaceutical Manufacturing

Section 6: Contamination and Contamination Control

  • Origin of Contamination
  • Quantitation of Markers for Gram-Negatie and Gram-Positive Endotoxins in Work Enironment and as Contaminants in Pharmaceutical Products Using Gas Chromatography–Tandem Mass Spectrometry
  • Microbiology of Nonsterile Pharmaceutical Manufacturing

Section 7: Drug Stability

  • Stability and Shelf Life of Pharmaceutical Products
  • Drug Stability
  • Effect of Packaging on Stability of Drugs and Drug Products
  • Pharmaceutical Product Stability
  • Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics

Section 8: Validation

  • Analytical Method Validation: Principles and Practices
  • Method Validation and Quality Assurance
  • Validation of Laboratory Instruments
  • Pharmaceutical Manufacturing Validation Principles

Index

See also:
Pharmaceutical Manufacturing Handbook: Production and Processes
Pharmaceutical Manufacturing Handbook 2-Volume Set

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Pharmaceutical Manufacturing Handbook
Regulations and Quality
edited by
Shayne Cox Gad

2008 • 858 pages • $194.00 + shipping
Texas residents please add 6.75 % sales tax

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