APR March 2024 - 17
« MICROBIOLOGY
Table 2. Critical Behavioral Attributes and Control Measures
Aseptic
Operation
Critical Behavioral
Attributes (CBAs)
Impacted Critical Quality
Attributes (CQAs)
Current Controls and Measures
* Batch record initial entry only upon the availability of primary operator, secondary operator,
sterile components, and disinfectant for filter assembly (Best Practice).
* Real-time observation and live feedback of the aseptic connections by microbiologist in the fill
room (Best Practice).
* IPQA on floor observation and live feedback of the aseptic practices (Best Practice).
* IPQA real-time video review and feedback of aseptic behaviors, including glove and gown
management (Best Practice).
* QA audit of aseptic practices recorded videos prior to batch release (Best Practice).
* The secondary operator hands over filter assembly connections; the primary operator unwraps
under LAF and immediately completes the connection (Best Practice).
Filling
Technique:
Filtration Assembly
Sterility Test
LAL Test
EM (Viable)
EM (Non-Viable)
EM (Personnel)
* The primary operator performed all tasks inside the filtration assembly station; the secondary
operator verified that the primary kept elbows off the cart (Best Practice).
* The secondary operator observes if the primary operator violates First Air principles while
assembling (Best Practice).
* The primary Operator sanitized gloves prior to and after performing an aseptic connection.
Secondary operator to facilitate and verify the same (Best Practice).
* Supervisory verification of training and qualification records prior to assigning operators for
assembly tasks. The verification is documented (Best Practice, COM-B).
* Adequate time for execution assigned for filter assembly during batch planning (Best Practice, COM-B).
*
Sufficient tools and resources, such as connecting tubes, additional carboy, gloves, and LAF space
available (COM-B).
* Peer witness and friendly prompting are part of internal aseptic operation practice (COM-B).
* Reward points issued in the system by the supervisor for the successful completion of filtration
assembly (COM-B).
* The supervisor conducts a pre-batch team meeting to identify and acknowledge the leads,
including for filtration assembly setup (COM-B).
Technique: Open Door Setup
Technique: Closed Door Setup
Technique: Stopper Loading
Skill: Cart Vessel Equipment Movement
Technique: Empty Vial Loading
Technique: Glove Box Use
Skill: Lyo Cart Vial Loading
Skill: Identified Interventions
Skill: Unplanned Interventions
Skill: EM Plates
Technique: Cleaning Disinfection
Technique: Glove Control
Technique: Gown Control
Technique: Personnel Monitoring
development and the Capability, Opportunity, and MotivationBehavior
(COM-B) model for behavioral change are relatively new
concepts introduced in 2008 and 2011, respectively. The industry has
also adopted lifecycle concepts since the introduction of the US FDA
process validation guidance in 2011. As established in the industry
best practices guidance, aseptic processes peremptorily require
control of aseptic behaviors to meet patient safety and product quality
needs. Further, to align with the current ICH and lifecycle concepts,
early identification and systematic mitigation or development of a
control strategy is required as part of product development (Stage 1).
The introduction of the Critical Behavioral Attributes (CBAs) elements
supports defining and enumerating the aseptic behavior controls
established for the product. The existence of CBA in your control
strategy acknowledges the importance of behavioral elements to
achieve sterility and prevent cross-contamination. The availability
of CBAs allows for future risk reduction opportunities, such as the
introduction of automation solutions. This is supported by the US
FDA's drive to modernize the industry.
This article integrates behavioral science concepts (COM-B model) and
CBAs with pharmaceutical best practices and regulatory considerations
(QbD and PV lifecycle). This connection emphasizes the need for
identification and systematic mitigation of behavioral challenges at
an early development stage rather than addressing them reactively.
The authors take this opportunity to call on manufacturers to adopt
this improved framework for addressing the current aseptic behavior
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| 17
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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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