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To perform a risk assessment for each TPMP subpart, factors such as the complexity of compliance, potential impact of non-compliance, resource demands, and likelihood of regulatory changes or challenges are considered. Each subpart will be evaluated on these criteria and ranked from highest to lowest risk.
To perform a risk assessment for each TPMP subpart, factors such as the complexity of compliance, potential impact of non-compliance, resource demands, and likelihood of regulatory changes or challenges are considered. Each subpart will be evaluated on these criteria and ranked from highest to lowest risk.
Subpart A - General Provisions
Subpart A - General Provisions
Challenges:
Understanding and interpreting the scope and definitions.
Ensuring all products and activities comply with the TPMP requirements.
Keeping up-to-date with any changes or updates to the regulations.
Resource Allocations:
Legal and compliance teams to interpret and implement regulations.
Training programs for staff to understand the scope and definitions.
Continuous monitoring systems to stay updated with regulatory changes.
Subpart B - Management System Requirements
Subpart B - Management System Requirements
Challenges:
Establishing and maintaining an effective organizational structure.
Handling tobacco product complaints efficiently.
Implementing Corrective and Preventive Actions (CAPA).
Resource Allocations:
Sufficient personnel with appropriate responsibilities and training.
Systems for complaint handling and CAPA implementation.
Documentation and record-keeping systems to track activities.
Subpart C - Buildings, Facilities, and Equipment
Subpart C - Buildings, Facilities, and Equipment
Challenges:
Ensuring buildings and facilities are suitable for manufacturing.
Maintaining equipment to prevent contamination.
Implementing effective environmental controls.
Resource Allocations:
Investment in suitable buildings and facilities.
Regular maintenance and calibration of equipment.
Environmental control systems and monitoring tools.
Subpart D - Design and Development Controls
Subpart D - Design and Development Controls
Challenges:
Controlling the design and development of tobacco products.
Managing risks associated with the product and production process.
Ensuring design verification and validation.
Resource Allocations:
Design and development teams with expertise in risk management.
Tools and software for design verification and validation.
Procedures and documentation for design control activities.
Subpart E - Process Controls
Subpart E - Process Controls
Challenges:
Establishing and maintaining purchasing controls.
Implementing acceptance activities for incoming and in-process materials.
Managing nonconforming products and reprocessing.
Resource Allocations:
Quality control and assurance teams.
Systems for tracking and documenting acceptance activities.
Procedures and tools for handling nonconforming products.
Subpart F - Packaging and Labeling Controls
Subpart F - Packaging and Labeling Controls
Challenges:
Ensuring compliance with multiple regulations.
Preventing mix-ups in packaging and labeling.
Maintaining accurate records of packaging and labeling activities.
Resource Allocations:
Approval processes and administrative oversight.
Technological solutions like barcode scanners and label printers.
Training programs for personnel involved in packaging and labeling.
Subpart G - Handling, Storage and Distribution
Subpart G - Handling, Storage and Distribution
Challenges:
Preventing contamination during handling and storage.
Ensuring proper conditions for storage and distribution.
Maintaining traceability of products throughout the supply chain.
Resource Allocations:
Storage facilities with appropriate environmental controls.
Distribution systems that ensure product integrity.
Tracking systems for product traceability.
Subpart H - Recordkeeping and Document Controls
Subpart H - Recordkeeping and Document Controls
Challenges:
Maintaining accurate and up-to-date records.
Ensuring records are attributable, legible, and contemporaneously recorded.
Establishing procedures for document approval and changes.
Resource Allocations:
Recordkeeping systems and software.
Personnel trained in document control procedures.
Regular audits to ensure compliance with recordkeeping requirements.
Subpart I - Small Tobacco Product Manufacturers
Subpart I - Small Tobacco Product Manufacturers
Challenges:
Delayed compliance date, requiring planning for future implementation.
Limited resources compared to larger manufacturers.
Ensuring all TPMP requirements are met within the extended timeframe.
Resource Allocations:
Planning and budgeting for future compliance.
Training programs tailored to small manufacturers.
Incremental implementation strategies to spread out resource allocation.
Subpart J - Exemptions and Variances
Subpart J - Exemptions and Variances
Challenges:
Understanding the procedures for petitioning for exemptions or variances.
Preparing and submitting comprehensive petitions.
Complying with TPMP requirements while petitions are under review.
Resource Allocations:
Legal and regulatory teams to prepare petitions.
Documentation and evidence to support exemption or variance requests.
Systems to track the status of petitions and ensure ongoing compliance.
Risk Assessment and Ranking
Risk Assessment and Ranking
Subpart B - Management System Requirements
Subpart A - General Provisions
Subpart E - Process Controls
Subpart G - Handling, Storage, and Distribution
Subpart F - Packaging and Labeling Controls
Subpart C - Buildings, Facilities, and Equipment
Subpart D - Design and Development Controls
Subpart H - Recordkeeping and Document Controls
Subpart J - Exemptions and Variances
Subpart I - Small Tobacco Product Manufacturers
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