Risk Management Library Volume 6, Risk Problem Solvers: Lack of Process Understanding (single user digital version)

Feb 2018
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series

The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is the time to get up to date on managing risk to safely produce healthcare products!

In order to help you, we have gathered chapters from our most successful risk-based texts. These convenient, electronic texts define risk, discuss hazards and risks, provide tools to help you evaluate risk, and develop effective strategies for dealing with risk.

Written by subject matter experts, each text contains practical applications, an extensive list of international regulations for reference, and suggested PDA Technical Reports and books for further guidance.

Risk Management Library Volume 6, Risk Problem Solvers: Lack of Process Understanding

This publication is taken from the book: Lessons of Failure: When Things Go Wrong In Pharmaceutical Manufacturing published in 2015.

This Volume discusses diagnosis and corrective actions to common problems, such as incorrect batch records, contaminated product complaints, contamination, environmental monitoring, and many other subjects.

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Format: PDF (1 file 0.99 MB)

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. Two Wrongs Don't Make a Right (Chapter excerpted from Lessons of Failure: When Things Go Wrong In Pharmaceutical Manufacturing, Chapter 4)
  2. Loss of a Single Freeze Dryer Load; Doubles Capacity (Chapter excerpted from Chapter 9)
  3. Fungal Contamination of Allopurinol Tablets (Chapter excerpted from Chapter 10)
  4. Contaminated Product Complaint (Chapter excerpted from Chapter 11)
  5. Where's the Flow? (Chapter excerpted from Chapter 13)
  6. Endotoxin Testing (Chapter excerpted from Chapter 14)
  7. Bioreactor Contamination (Chapter excerpted from Chapter 16)
  8. Media Fill Failure: Blow-Fill-Seal Aseptic Processing (Chapter excerpted from Chapter 20)
  9. Validation Study Design and Assumptions (Chapter excerpted from Chapter 23)
  10. Bacterial Contamination of Alcohol Swabs (Chapter excerpted from Chapter 27)
  11. Whom Do You Trust — Head of R&D or Junior Engineer? (Chapter excerpted from Chapter 28)
  12. White Precipitate 2 (Chapter excerpted from Chapter 30)
  13. Environmental Monitoring (Chapter excerpted from Chapter 32)
  14. Fusarium Keratitis Outbreak Associated with a Reformulated Contact Lens Solution (Chapter excerpted from Chapter 35)
  15. Environmental Monitoring and the Human Factor (Chapter excerpted from Chapter 39)
  16. Viral Contamination of Early Batches of the Salk Polio Vaccine (Chapter excerpted from Chapter 44)
  17. 2, 4, 6-Tribromoanisole Taints OTC Drug Products (Chapter excerpted from Chapter 45)
  18. Of Course it is Better (Chapter excerpted from Chapter 48)
  19. There's Something Wrong with the Biological Indicators (Chapter excerpted from Chapter 53)
  20. Disintegration (Chapter excerpted from Chapter 60)
  21. Gaskets (Chapter excerpted from Chapter 62)
  22. The Change is Not Critical — or is it? (Chapter excerpted from Chapter 66)
    Current Regulations, Guidances, Technical Reports and Texts Useful for Further Reference.

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.