Product Formulation Realization Gap Assessment Service

Service Description:

– Product Formulation Realization Gap Assessment Service
– An analysis of your current Quality System performance for the
purpose of compliance per the PMTA prerequisite requirements
and applicable regulatory requirement(s) of 27 CFR Part 40 –
Manufacture of Tobacco Products, Cigarette Papers and Tubes,
and Processed Tobacco, 21 CFR Part 1140 Cigarettes, Smokeless,
Tobacco, and Covered Tobacco Products.
– Gap Assessment Service – Document (Program) Off Site Audit.
– Gap Analysis – Report per the specified inspection, if applicable,
respective to the regulatory or certification guidelines.

Requirements:

– Pre-schedule by contacting services@consultareinc.com
– Subject to consultant and facility representative schedule
availability.
– Gap Analysis are based on specified regulatory requirements and
Quality System guidelines, if applicable.
– Consultancy Services are non-refundable.
– In the event of a scheduled conflict, client may re-schedule the
Consultancy Service.
– Google Meet – Screen Share for discussion. To be scheduled by our
Compliance Team, if applicable.
-Recommendation and guidance given or implied are based on best
practices and the adherence to a regulatory or certification body
requirements or a Quality System and may or may not conform to
the requirements or the intended use or application.

Deliverables:

– Consultancy Service – Gap Analysis – Off Site – 3 Days – Virtual
with Document Review or Off-Site Document Review.
– Gap Analysis Report – Per the specified inspection, if applicable,
respective to the regulatory or certification guidelines or Quality
System.

Delivery Date:

– Scheduled per consultant and facility representative availability.