1.0 OBJECTIVE
To provide a procedure to evaluate a potential new source or to monitor ongoing quality on a routine basis for existing vendors.
2.0 SCOPE
This SOP shall be applicable to all vendors manufacturing raw & packaging materials supply to the BPL.
3.0 ASSOCIATED DOCUMENTS
Not applicable.
4.0 ...
Objective
To provide a procedure to audit a new vendor or re-audit an existing vendor for the active / inactive ingredients and packaging materials.
Scope
This procedure is applicable for approval of all vendors (manufacturers) and suppliers of incoming Active Pharmaceuticals Ingredients (APIs), Inactive ...
A visit program shall be chalked out and an audit team shall be constituted. The Head of Quality shall inform Purchase Manager to finalize the program. The vendor shall be informed at least one week earlier of the proposed visit date & ‘Vendor Questionnaires’ shall be send to the packaging material ...