Recalls of Pharmaceutical Products: Eliminating Contamination and Adulteration Causes (single user digital version)

Mar 2020
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PDF Single user
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Are you prepared for recalls relating to pharmaceutical and healthcare medications and medical devices? This book contains details about recalls from start to finish, including advice on how to handle a recall and, more importantly, how they can be avoided. Read about regulatory perspectives, trends and primary causes for product recalls, notable recalls and lessons, quality metrics, and supply chain risk management. You can also find relevant information designed to help about labels, packaging, data integrity, methods to ensure GDP, and other industry best-practices.

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Format: PDF (1 file 4.14 MB)

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. Setting the Recall Context
  2. Recalls and GMP: What are the Regulators Saying?
  3. Recall Trends and the Primary Causes for Product Recalls
  4. Economic Consequences of Pharmaceutical Recalls
  5. A Histrory of Errors: The Most Serious Global Drug Incidents and Recalls
  6. Predictive Models to Assess Pharmaceutical Recalls
  7. Sterile Pharmaceutical Products: Notable Recalls and Pertinent Lessons
  8. Pharmaceutical Product Recalls Associated with Fungal Contamination
  9. Burkholderia Cepacia Complex: Example of Non-Sterile Product Recall Due to Microbiological Contamination
  10. Chemical Adulteration of Pharmaceutical Products and Analytical Methods for the Assessment of Adulterants
  11. Batch Processing Records: Good Design and the Missteps with Human Error
  12. Labels and Packaging: Errors and Misapplication
  13. Avoiding Errors with the Batch Release Process
  14. Data Integrity Failures and the Recall of Medicines
  15. Effective Good Distribution Practice to Avoid Recalls
  16. Essential Requirements for a Global Recall Strategy
  17. Anatomy of A Recall Standard Operating Procedure
  18. Putting the Report Together: How to Respond Effectively to Regulators and Customers
  19. Pharmaceutical Advertising and Marketing in the Digital Age
  20. Connecting Recalls and the GMP Inspection Process
  21. Safe Disposal of Recalled and Unwanted Medicines
  22. Quality Metrics - Improving Performance to Reduce Recalls
  23. Avoiding Recalls by Applying Risk Management to the Supply Chain
  24. Supply Chain: Avoiding Recalls and Applying Technologies to Safeguard the Medicinal Flow

About the Authors

About the Author

Dr. Tim Sandle has over 25 years' experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology and Sterility Assurance at Bio Products Laboratory, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester. In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control, including the Pharmaceutical Microbiology Interest Group (Pharmig) and PDA technical working groups. He is also a member of several editorial boards for scientific journals. Dr. Sandle has written over 600 book chapters, peer reviewed papers and technical articles relating to microbiology. These include the DHI/PDA books Sterility Testing of Pharmaceutical Products, Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies, Cleanroom Microbiology, Aseptic and Sterile Processing: Control, Compliance and Future Trends, and Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers, as well as the books Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control and Biocontamination Control for Pharmaceuticals and Healthcare.