– Program and Applicable Form(s): Product Development and
Realization Quality System Program Development
– Customized for Quality System compliance with PMTA
prerequisite requirements and applicable 27 CFR Part 40 –
Manufacture of Tobacco Products, Cigarette Papers and Tubes,
and Processed Tobacco.
– Program Document includes the following Sections; Program,
Signatories, Purpose, Scope, Introduction, Policy, Procedures,
Responsibility, Corrective Action, Review Requirements,
References, and History.
– Send approved company logo and your facility address to be
incorporated on the documents, if applicable, to
– Google Meet – Screen Share for discussion. To be scheduled by our
Compliance Team, if applicable.
– Program(s), Policy (or Policies), Procedure(s), and Form(s)
purchased require customization, review, and approval for their
intended use. Review, and approval are not included on this service.
– Should you need customization assistance, please schedule a
complimentary discussion via gmeet screen share with our
Compliance Team by emailing email@example.com.
-Recommendation and guidance given or implied are based on best
practices and the adherence to a regulatory or certification body
requirements and may or may not conform to the requirements or
the intended use or application.
– Consult your inhouse Practitioner, Preventive Control Qualified
Individual (PCQI) or Qualified Individuals (QI) prior to the
implementation of the Program(s), Policy (or Policies), Procedure(s),
– Program(s), Policy (or Policies), Procedure(s), and Form(s) created
requires review and approval by your company’s authorized
personnel and qualified personnel.
– Program in word format: Product Development and Realization
Quality System Program
– Form(s) in word or excel format: Product Development
Validation and Verification Form.
-7 to 10 Business Days upon receipt of completed information
required for inputs.