APR March 2024 - 18

» MICROBIOLOGY
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regulatory challenges and to achieve consistent behavioral patterns.
The facility's contamination control strategy may also incorporate the
presence of a site COM-B model and the existence of CBA controls for
aseptically manufactured products. The introduction of the framework
also enhances the site's Quality Management Maturity (QMM)21
as it
displays a high level of management commitment to quality, advances
the existing Pharmaceutical Quality System (PQS, and effectively
improves employee engagement and empowerment.
References:
1.
2.
founder of SHJ Consulting Services, providing GMP consulting services.
Having held senior leadership roles, including Senior Vice President of
Quality Assurance at Hospira, Orchid Healthcare as VP of Quality, Dr.
Reddy's, and Lupin, Satish has excelled in various functions like QA,
Compliance, QC, Analytical Development, and Packing Development. His
expertise extends to successfully navigating regulatory inspections from
agencies such as USFDA, MHRA, TGA, ANVISA, Taiwan and GCC. Notably,
Satish is recognized for his pivotal role in setting up Greenfield projects
and establishing robust Quality procedures and systems. He is committed
to excellence and strategy, contributing significantly to the industry's
adherence to compliance and quality standards.
FDA (2024) Data Dashboards- Inspections, US FDA. https://datadashboard.fda.gov/ora/cd/
inspections.htm
FDA (2024) Warning Letters, US FDA. https://www.fda.gov/inspections-complianceenforcement-and-criminal-investigations/compliance-actions-and-activities/warningletters
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Wang, F. et al. (2012) Acute intraocular inflammation caused by endotoxin after intravitreal
injection of counterfeit bevacizumab in Shanghai, China. Ophthalmol.
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patterns in a cleanroom, Building and Environment 37(7):705-712.
Sandle, T. (2023) Glove disinfection and aseptic technique: Creating a schema for the
cleanroom and laboratory EJPPS, 282.
Deveau, I. F. (FDA) FDA Inspectional Observations and Corrective Actions, CDER.
Larkin, D. (2012) The contamination risks posed by laundered cleanroom apparel,
Kimberly-Clark Professional.
Soper, M. (2017) How can Employees Contaminate a Clean Environment? Setra
Friedman, R. L. (2005) Aseptic processing contamination case studies and the
pharmaceutical quality system. PDA journal of pharmaceutical science and technology.
PDA (2013) Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic
Processes, PDA.
ISPE (2018) Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition, ISPE.
PDA (2015) Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection
Programs for Aseptic Manufacturing Facilities, PDA.
PDA (2016) Points to Consider for Aseptic Processing, PDA.
PDA (2011) Technical Report No. 22, Process Simulation for Aseptically Filled Products, PDA.
PDA (2008) Technical Report No. 44, (TR 44): Quality Risk Management for Aseptic
Processes, PDA.
16. Michie, S., Atkins, L., & West, R. (2014). The behaviour change wheel: A guide to designing
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Zheng, S, Yang, Q, Wang, X, Zhang, X, Zhou, Q. (2022) Capability, Opportunity, Motivation,
and Hand Hygiene Behavior in Healthcare Workers: A Structural Equation Modeling.
Psychol Res Behav Manag, 15:2219-2228.
ICH (2008} Q8 (R2) Pharmaceutical Development, ICH.
FDA (2011) Process Validation: General Principles and Practices, FDA.
ICH (2019) Q12 Technical and Regulatory Considerations For Pharmaceutical Product
Lifecycle Management, ICH.
FDA (2023) CDER's Quality Management Maturity (QMM) Program: Practice Areas and
Prototype Assessment Protocol Development, FDA.
Author Biographies
Satish Joshi is a distinguished figure and renowned consultant in the
pharmaceutical industry with over 28 years of experience. He is the
18 |
| March 2024
Dr. Ajay Pazhayattil is a seasoned management consultant and an
industrial pharmacist with experience in the industry's sterile, solid oral,
and API sectors. He is the founder of cGMPWorld and a founding partner
at Itaan Pharma, an injectable manufacturer. He has been in leadership
roles with North American pharmaceutical brands, generics and CDMOs,
including VP QA, Scientific & RA at Capcium, Quality Director at Eurofins,
Asso. Director at Apotex, etc. Ajay plays a key role in assisting organizations
to navigate compliance and remediation efforts arising from FDA 483s
and WL scenarios. He has been the lead author and contributor for
industry guidance documents, including PDA, ISPE, AAPS and RAPS. With
a blend of technical acumen, strategic vision, and operational experience,
Ajay continues to make significant industry contributions.
Marzena Ingram is an accomplished independent senior pharmaceutical
consultant. She brings to the table a wealth of experience in quality
and technical operations and process validation. At the forefront of
her responsibilities is the critical task of addressing FDA warning letter
scenarios for clients, ensuring compliance and regulatory adherence.
Her strategic leadership and meticulous attention to detail have enabled
her to spearhead compliance programs and initiatives meeting global
regulatory requirements and to set new benchmarks in the industry. She
has developed and led specialized teams at high-volume manufacturing
organizations. Marzena serves as the Vice President of the International
Society for Pharmaceutical Engineering (ISPE) Canada. She plays a pivotal
part in shaping the industry's future, contributing to the advancement of
pharmaceutical science and fostering collaboration among professionals.
Mava Fakoori Mava Fakoori is a highly skilled psychotherapist, holding
a Master of Arts in Clinical Psychology. With a deep understanding
of cultural nuances shaping adherence and viewpoints, Mava's
clinical psychotherapy practice encompasses children, adults, older
adults, couples, families, and the LGBTQ community. Specializing in
psychoanalytic and somatic therapy, Mava brings a unique perspective to
her counseling approach. She navigates the complexities of cognitive and
behavioral elements to influence positive outcomes. As an experienced
therapist, Mava provides comprehensive care beyond traditional
modalities. Beyond her clinical work, Mava is a captivating voice in
behavioral psychology. She hosts engaging shows on two radio stations
and contributes insightful articles to " Today's Women " magazine. Actively
involved in the Iranian Psychological Association of America (IPAA), Mava
is committed to advancing the understanding of behavioral science and
psychology for the well-being of a broad spectrum of individuals.

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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