APR March 2024 - 40

VENDOR VIEWPOINT
Data Integrity and Rapid Micro
Methods: Transforming to a
Modern Microbiology Lab
Tony Saavedra
Life Sciences Product Manager
Hayden Skalski
Lead Applications Specialist, Microbial Detection
Veolia Water Technologies & Solutions, Sievers Instruments
The pharmaceutical industry is a dynamic and rapidly evolving field, with data
integrity and rapid microbial methods (RMMs) playing pivotal roles in shaping
the future of microbiology labs. These elements are not just integral to the
functioning of labs, but are also transforming the way they operate, bringing
about increased accuracy, efficiency, and reliability in drug development and
testing processes. Let's delve a little deeper into the significance of data integrity
and RMMs, providing detailed examples of their application and impact on
modern microbiology labs in the pharmaceutical industry.
Tony Saavedra is the Life Sciences Product
Manager at Veolia Water Technologies &
Solutions, focusing on Sievers total organic
carbon (TOC) software and instrumentation.
Tony began his tenure with the Sievers product line as part
of GE Analytical Instruments in 2011 in the field service
organization and later held responsibility for leading the
North America Technical Services team where he oversaw
technical support, factory service, and refurbishment process
operations. Prior to his positions with Sievers products, Tony
served for 10 years in the US Navy where he supervised
flight inspections and performed quality assurance
inspections and maintenance of complex electronic radar
and communication suites. Tony holds a BS in Electronic
Engineering Technology from ECPI University and an MBA
from Colorado State University.
Hayden Skalski is the Lead Life Sciences
Product Application Specialist for the Sievers
Instruments product line at Veolia Water
Technologies & Solutions, specializing in
bacterial endotoxins testing (BET) and rapid microbial
methods (RMMs). Hayden has over 8 years of experience
in the pharmaceutical industry and Quality Control
Microbiology and has presented on numerous topics
surrounding endotoxin testing. Previously, Hayden held
roles at Charles River Laboratories, Regeneron and Novartis,
validating and executing method development protocols
for endotoxin testing, providing customer support,
troubleshooting and supporting high-volume product
testing. Hayden has a B.S. from the University at Albany
(SUNY) in Biology.
Data Integrity in Microbiology Labs
Data integrity, defined as the maintenance of and the assurance of the accuracy
and consistency of data and metadata over its entire life cycle, is a critical aspect
of microbiology labs. It ensures that the data generated is reliable and can be
trusted for decision-making processes.
Violations involving data integrity continue to be observed during FDA
inspections. Without strong data integrity practices, microbiology labs will have
less confidence in their data to make informed decisions and meet regulations.
Whether data are inadvertently or purposefully manipulated, any gaps in the
security of data reporting and handling introduce significant risk to operations
and to patients.
For example, data integrity concerns cited in FDA form 483 observations include:
* Failure to implement adequate controls to support the integrity of
electronic data and to ensure that only appropriate individuals had
administrative rights
* Human errors through manual transcription of microbiological data or
incorrect counting of colonies
* A lack of control to prevent deletion of raw data
* A lack of training protocols for the cGMP training of employees,
including training personnel to prevent and detect data integrity
issues
* A lack of audit trail review and inadequate data review procedures
In the pharmaceutical industry, data integrity is crucial for maintaining
regulatory compliance, ensuring patient safety, and enhancing the overall
quality of pharmaceutical products. For example, in the development of
therapeutics or cell and gene therapies, data integrity plays a crucial role in
ensuring safety and efficacy. The data generated throughout development and
manufacturing must be accurate, consistent, and reliable to gain public trust
40
American Pharmaceutical Review | March 2024

APR March 2024

Table of Contents for the Digital Edition of APR March 2024

Message from the Editor
Editorial Advisory Board
BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
An Interview with Dan Smithey, PhD President & CEO, Serán
FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
QC Corner - Enhancing Material and Equipment Availability in Production Isolators
BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
DRUG DELIVERY - Your Nails and You
DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
Event Preview - CPHI North America
Event Preview - Excipient World 2024
P.I.N. Points
Advertiser's Index
APR March 2024 - CoverTip01
APR March 2024 - CoverTip02
APR March 2024 - Cover1
APR March 2024 - Cover2
APR March 2024 - 1
APR March 2024 - 2
APR March 2024 - 3
APR March 2024 - 4
APR March 2024 - 5
APR March 2024 - Message from the Editor
APR March 2024 - Editorial Advisory Board
APR March 2024 - BIOPHARMACEUTICALS - Getting to GMP-Quality Biotherapeutics From Today’s Bench-Scale Continuous Manufacturing Systems: A Gap Analysis
APR March 2024 - 9
APR March 2024 - 10
APR March 2024 - 11
APR March 2024 - 12
APR March 2024 - 13
APR March 2024 - MICROBIOLOGY - Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing
APR March 2024 - 15
APR March 2024 - 16
APR March 2024 - 17
APR March 2024 - 18
APR March 2024 - FORMULATION AND DEVELOPMENT - Use of AUC in AAV Analysis in a GMP Setting
APR March 2024 - 20
APR March 2024 - 21
APR March 2024 - 22
APR March 2024 - 23
APR March 2024 - FORMULATION AND DEVELOPMENT - Precision Medicine in Clinical Trials: A Statistical Perspective
APR March 2024 - 25
APR March 2024 - 26
APR March 2024 - 27
APR March 2024 - An Interview with Dan Smithey, PhD President & CEO, Serán
APR March 2024 - 29
APR March 2024 - 30
APR March 2024 - FORMULATION AND DEVELOPMENT - Still Early Days for AI in Drug Discovery...Says Who?
APR March 2024 - 32
APR March 2024 - 33
APR March 2024 - QC Corner - Enhancing Material and Equipment Availability in Production Isolators
APR March 2024 - 35
APR March 2024 - BIOPHARMACEUTICALS - Technologies for Aseptic Filling: The Choice is Clear
APR March 2024 - 37
APR March 2024 - 38
APR March 2024 - 39
APR March 2024 - Vendor Viewpoint - Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
APR March 2024 - 41
APR March 2024 - MICROBIOLOGY - Bacterial Spore Formers in Disinfectant Efficacy Testing
APR March 2024 - 43
APR March 2024 - Partner Perspective - Nanoparticle Technologies: Enablers for Ocular Drug Delivery
APR March 2024 - 45
APR March 2024 - 46
APR March 2024 - 47
APR March 2024 - DRUG DELIVERY - Your Nails and You
APR March 2024 - 49
APR March 2024 - 50
APR March 2024 - 51
APR March 2024 - DRUG DEVELOPMENT - Battling Exorbitance: High Costs in Sickle Cell Gene Therapies and the Imperative of Global Patient Registries for Equity
APR March 2024 - 53
APR March 2024 - 54
APR March 2024 - 55
APR March 2024 - FORMULATION AND DEVELOPMENT - How Pharma Companies Are Solving Regulatory Challenges with AI-based Technology
APR March 2024 - 57
APR March 2024 - Event Preview - CPHI North America
APR March 2024 - 59
APR March 2024 - Event Preview - Excipient World 2024
APR March 2024 - 61
APR March 2024 - P.I.N. Points
APR March 2024 - 63
APR March 2024 - Advertiser's Index
APR March 2024 - Cover3
APR March 2024 - Cover4
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