Follow
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 manufacturer.
An opening meeting shall be arranged with the vendor to inform them about the purpose of audit. The information provided by the vendor in the questionnaire shall be checked in case of new sources, production facilities & in-process control procedure shall be checked.
It shall be checked whether always written manufacturing instruction and related SOPs are followed or not. A batch shall be selected. Analytical report, manufacturing documentation and approval procedure of the primary packaging material shall be checked. In case of secondary packaging material a product shall be selected and all the steps of printing operation shall be checked according to procedure.
The Quality Control Laboratory facilities shall be checked for adequacy of testing equipment (if applicable). It shall also be checked whether all the tests are carried out as declared and the results meet specification.
General Housekeeping and safety measures shall be observed.
A closing meeting shall be conducted and the vendors shall be briefed about their requirements and their overall performance. Audit report shall be prepared and submitted to Head of Quality for his comment along with Vendor Audit Summary Report. Audit Report along with summary report shall be sent to Purchase Manager for his comment. Purchase Manager shall return it to Quality Assurance Department
The original copy shall be kept in Quality Assurance Department and one photocopy shall be sent to Purchase Department to take necessary action with the vendor & audit shall be carried out before vendor approval and the ongoing process shall be monitored once in a year or as per comment on Audit Report.
