Pharmaceutical API selection is an important part of a pharmaceutical industry. Where an API play a vital rule on product quality and process adaptability. So the selection of API should be based on the quality, feasibility and required documents availability.
Following information need to be collected from a manufacturer during vendor assessment of API as a questionnaire basis -
- Name of the material (API)
- Certificate of Analysis (COA) of the material
- Any approved DMF/EDMF (by USFDA/EMA) for the material
- Compendia reference (BP/EP/USP/JP)
- Manufacturing process/synthesis way
- Any specialized manufacturing equipment used
- Shelf life of the material
- Packing quantity (minimum and maximum) & Packaging material
- Storage condition of the material
- Any sensitivity of the material (metal, oxygen etc.)
- Established in-process control is available or not
- Which type of solvent used during manufacture/synthesis
- Residual solvent statement availability
- Elemental impurities declaration
- N-nitosamine impunity deceleration
- Availability of solvent recovery procedure
- Any animal origin raw material used during synthesis
- Microbial analysis report
- Adequate stability data which is justify shelf life/ expiry date/ retest date.
- Validated test method
- Typical batch size
- Any precaution for material handling (MSDS)
After availability of required documents or certification R&D activities will begin and they will assess the all required critical material attributes. The R&D checklist for vendor approval may includes -
- Analytical parameters (Identification, Solubility, Assay, Relative substances/ impurities etc.)
- Particles size distribution
- Density (Bulk & Tapped)
- Flow property
- Compressibility
- Stability
We hope this checklist will help your company to select the right material for maintaining the quality of a product in a continuous manner.
Related: New Vendor Approval Process
