Lessons of Failure: When Things Go Wrong In Pharmaceutical Manufacturing (single user digital version)

Nov 2015
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Russ Madsen and Maik Jornitz have assembled fascinating stories from renowned industry practitioners who share their global work experiences to highlight root cause analysis and problem solving. Each story is written as a brief lesson that begins with a statement of the problem, the steps taken to analyze the problem and then — the solution. The variety of these lessons will not only help readers tailor their investigations but also support investigational teams. The real-life experiences included in this book can be a valuable tool for training quality assurance and production personnel. This is not your typical pharmaceutical publication and, once you start reading, you'll find it hard to put down.

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Table of Contents

Table of Contents:

    1. What Product is This?
    2. Salt, Anyone?
    3. The Curious Case of Three Missing Containers of Starting Material in the Batch
    4. Two Wrongs Don't Make a Right
    5. White Precipitate 3
    6. Wrong Direction
    7. A Better Way to Audit
    8. I've got it!...You take it!
    9. Loss of a Single Freeze Dryer Load; Doubles Capacity
    10. Fungal Contamination of Allopurinol Tablets
    11. Contaminated Product Complaint
    12. Bioburden Contamination in a Contained Water System
    13. Where's the Flow?
    14. Endotoxin Testing
    15. Cleaning Validation
    16. Bioreactor Contamination
    17. Material Decontamination Failure
    18. Door Kick Plates
    19. The "Five Second Rule" Does Not Apply
    20. Media Fill Failure: Blow-Fill-Seal Aseptic Processing
    21. An Aseptic Processing Intervention to Avoid
    22. It's a Like for Like Replacement
    23. Validation Study Design and Assumptions
    24. Not Invented Here 1
    25. Bury my Heart in the SOP
    26. The Complaint is Unjustified
    27. Bacterial Contamination of Alcohol Swabs
    28. Whom Do You Trust — Head of R&D or Junior Engineer?
    29. The Nitrogen Delivery Wasn't Made: Or Was It?
    30. White Precipitate 2
    31. Used the Right Gas? Are You Sure?
    32. Environmental Monitoring
    33. Alcohol-free Mouthwash Contaminated with Burkholderia cepacia Complex Causes Respiratory Infection and Death in Patients on Ventilators
    34. It's Okay,The Batch is Released
    35. Fusarium Keratitis Outbreak Associated with a Reformulated Contact Lens Solution
    36. How to Train a Body Builder
    37. Viral Contamination of Bioreactors used to Produce Enzyme Replacement Therapy
    38. Rapid Sterilizer Heat-Up
    39. Environmental Monitoring and the Human Factor
    40. Fungal Problems Sideline Vaccine Manufacturer
    41. Blue Sky
    42. Icodextrin used in Peritonal Dialysis Caused a Peak in Adverse Reactions
    43. Grease (Not the Movie)
    44. Viral Contamination of Early Batches of the Salk Polio Vaccine
    45. 2, 4, 6-Tribromoanisole Taints OTC Drug Products
    46. Not Enough Bottles?
    47. Technology Transfer
    48. Of Course it is Better
    49. You See What You Want to See
    50. Fungal Contamination of Tablets
    51. Not Invented Here 2
    52. Waterworks
    53. There's Something Wrong with the Biological Indicators
    54. Don't Just Sit There — Do Something
    55. Not Invented Here 3
    56. A 12-step Program for CGMPS: Lessons of a Pharmaceutical Lifetime
    57. Is Anybody Listening?
    58. White Precipitate 1
    59. It's a Simple Reformulation
    60. Disintegration
    61. The Troublesome Media Fill
    62. Gaskets
    63. Contamination of an Aseptic Fill
    64. Call Me in the Morning
    65. The Green Blob
    66. The Change is Not Critical — or is it?

About the Authors

About the Editors

Russel E. Madsen is President of The Williamsburg Group, LLC, providing expert pharmaceutical consulting services including CGMP compliance, quality systems, aseptic processing and sterilization, sterilizing filtration, design review, due diligence, and regulatory liaison. Prior to forming The Williamsburg Group, he had served PDA as Acting President and was Senior VP Science and Technology. Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director, Technical Services, providing technical and general consulting services to Bristol-Myers Squibb operations, worldwide. He is Vice-Chairman of ASTM E55.03 General Pharmaceutical Standards, a member of the USP Microbiology Expert Committee, Chairman of the USP Visual Inspection of Parenterals Expert Panel, a member of Pharmaceutical Technology's Editorial Advisory Board, and an Honorary Member of PDA. He holds a Bachelor of Science degree from St. Lawrence University and a Master of Science degree from Rensselaer Polytechnic Institute.

Maik W. Jornitz is is the Founder and Principal Consultant of BioProcess Resources LLC. BioProcess Resources LLC, is a consulting group specialized in sterilizing filtration, integrity testing and single-use technology. Jornitz has close to 30 years of experience in separation and single-use technologies, the related regulations and validation requirements. Jornitz supports the biopharmaceutical industry on a worldwide basis. As a former member of the PDA Board of Directors (former Chair of the Board of Directors) and member of the Science Advisory Board (SAB), Jornitz has been part of multiple PDA task forces, for example the Technical Report # 26, #40, #41, #45, mycoplasma task forces, and program co-chair for the 2008, 2013 and 2016 Annual Meeting. He is also member of the ISPE, ASTM, ASME, and is faculty member of PDA TRI and Global Compliance. Jornitz authored and co-authored over 100 scientific papers. He is co-editor and author of 9 books for example Filtration and Purification in the Biopharmaceutical Industry, Sterile Filtration — A Practical Approach, Pharmaceutical Filtration and received 5 distinguished author awards, 2 PDA Special Service, the Michael S. Korczynski and Martin Van Trieste award. He has contributed in total 15 chapters to various technical books, including the Encyclopedia of Pharmaceutical Technology. He holds over 30 patents related to biopharmaceutical process equipment (single-use technology) and integrity testing. He formerly worked for Sartorius Stedim in various positions for over 25 years, is Science Advisory Board member of Artemes Technologies and member of the Biotechnology Industry Council. Mr. Jornitz received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.