Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Microbiological Test Data-Assuring Data Integrity.

Edward C Tidswell1, Tim Sandle2

  • 1Executive Director, Merck, West Point, PA 19486 Edward.tidswell@merck.com.

PDA Journal of Pharmaceutical Science and Technology
|October 15, 2017
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Non-sterile Drug Products - Microbiologically Related Recalls and Compliance Issues.

PDA journal of pharmaceutical science and technology·2026
Same author

Clarifications on the Intended Use of USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests.

PDA journal of pharmaceutical science and technology·2024
Same author

A Nontrivial Analysis of Patient Safety Risk from Parenteral Drug- and Medical Device-Borne Endotoxin.

Drugs in R&D·2023
Same author

Microbial Contamination in Water Systems.

PDA journal of pharmaceutical science and technology·2022
Same author

Sterility Assurance-Current and Future State.

PDA journal of pharmaceutical science and technology·2021
Same author

Assessment of airborne endotoxin in sandstorm dust and indoor environments using a novel passive sampling device in Al Zulfi city, Saudi Arabia - Establishing threshold exposure levels.

Saudi journal of biological sciences·2021

Microbiological testing variability in drug manufacturing can lead to data integrity issues. Understanding these variations is key to implementing effective strategies that ensure patient safety and product quality.

Area of Science:

  • Microbiology
  • Pharmaceutical Quality Control
  • Regulatory Science

Background:

  • Marketed drugs and devices require critical microbiological quality attributes for efficacy and patient safety.
  • Current quality assurance relies on sampling, testing, and data interpretation for raw materials, intermediates, and final products.
  • Traditional culture-based microbiological methods exhibit inherent variability, potentially impacting product quality assessments.

Purpose of the Study:

  • To review legislative requirements for microbiological quality attributes.
  • To discuss the inherent variability of traditional microbiological testing methods.
  • To outline realistic strategies for assuring product quality and patient safety.

Main Methods:

  • Literature review of legislative requirements and compendial recognition of variability.
Keywords:
Bioburden testData integrityMicrobiological quality attributesMicrobiological testsSterility test

Related Experiment Videos

  • Analysis of the link between microbiological variability and data integrity issues.
  • Exploration of preventative strategies beyond laboratory capacity expansion.

    • Main Results:

    • Culture-based methods have unavoidable variability, recognized by regulatory bodies.
    • This variability is intrinsically linked to data integrity concerns in pharmaceutical manufacturing.
    • Effective strategies exist to genuinely assure patient safety beyond increased testing capacity.

    Conclusions:

    • Understanding microbiological variability is crucial for identifying genuine data integrity issues.
    • Implementing robust preventative strategies is essential for ensuring finished product quality.
    • Adherence to legislative requirements and realistic actions safeguard patient safety.