How to preparetion Specifications and STP, how to review MFC, MPR.

Question

Accepted Answer

To prepare Specifications and STP, review MFC and MPR, follow these steps.

Gather requirements and define specifications for the product or process.
Create detailed test cases in the Software Test Plan (STP) based on the specifications.
Review the Master Formula Card (MFC) for manufacturing processes and procedures.
Review the Master Production Record (MPR) for documenting the production process.
Ensure that the specifications align with the MFC and MPR for consistency.
Conduct thorough reviews of the MFC and MPR to identify any discrepancies or errors.

Accepted Answer

Specifications STP prepared as USP and Europe monograph and AMV documents  MFC  : review as per specifications, inline with BOM, matrial Name, quantity label claim, product code, vendor grade and materials, formulation process check.
MPR: batch size, item code, packing material inline with BOM, vendor details pack size product code check.

How to preparetion Specifications and STP, how to review MFC, MPR.

Popular interview questions of Quality Assurance

Top HR questions asked in Intas Pharmaceuticals Quality Assurance