Shelf Life and Stability Program.

Service Description:

– Program and Applicable Form(s): Shelf Life and Stability
Program includes; Register, Shelf Life Study Protocol, Shelf Life
Evaluation Log Sheet, Shelf Life Study Report – Real-Time, Shelf
Life Study Report – Accelerated Time, Stability Statement,
Stability Statement Validation.
– Document will include the following Sections; Program,
Signatories, Purpose, Scope, Introduction, Policy, Procedures,
Responsibility, Corrective Action, Review Requirements,
References, and History.

Requirements:

– Send approved company logo and your facility address to be
incorporated on the documents, if applicable, to
services@consultareinc.com.
– 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 services@consultareinc.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),
and Form(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.

Deliverables:

– Program and Applicable Form(s) in word or excel format: Shelf
Life and Stability Program includes; Register, Shelf Life Study
Protocol, Shelf Life Evaluation Log Sheet, Shelf Life Study Report –
Real-Time, Shelf Life Study Report – Accelerated Time, Stability
Statement, Stability Statement Validation.

Delivery Date:

– 5 to 7 Business Days upon receipt of completed information
required for inputs.