Follow
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 RESPONSIBILITY/ACCOUNTABILITY
4.1 Head of Quality shall be responsible for constituting an Audit team and giving his comment reviewing the Audit Report.
4.2 Manager, Quality shall be responsible for reviewing the Questionnaire of vendors for raw/primary packaging materials, testing samples and evaluating the performance of the vendors.
4.3 Manager, Quality or his /her nominee shall be responsible for reviewing the Questionnaire of vendors of secondary packaging materials before going for Audit.
4.4 Purchase Manager shall be responsible for sending vendor Questionnaire to national and international vendors, finalizing the audit program, taking necessary action on vendors after getting the audit report. He is also responsible to give his comment about customer service on vendor audit summary report.
4.5 Audit Team shall be responsible for carrying out the Audit Program and preparation and submission of Vendor Audit Report.
5.0 ABBREVIATIONS AND DEFINITIONS
Not applicable.
6.0 PRECAUTIONS /SPECIAL INSTRUCTIONS
Not applicable.
7.0 PROCEDURE
7.1 Vendor for Primary/Secondary Packaging Material
7.1.1 A visit program shall be chalked out and an audit team shall be constituted.
7.1.2 The Head of Quality shall inform Purchase Manager to finalize the program.
7.1.3 The vendor shall be informed at least one week earlier of the proposed visit date.
7.1.4 The ‘Vendor Questionnaires’ (Form nos. GE023-01, GE023-02) shall be send to the packaging material manufacturer.
7.1.5 An opening meeting shall be arranged with the vendor to inform them about the purpose of audit.
7.1.6 The information provided by the vendor in the questionnaire shall be checked in case of new sources.
7.1.7 The production facilities & in-process control procedure shall be checked.
7.1.8 It shall be checked whether always written manufacturing instruction and related SOPs are followed or not.
7.1.9 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.
7.1.10 The Quality Control Laboratory facilities shall be checked for adequacy of testing equipment (if applicable).
7.1.11 It shall also be checked whether all the tests are carried out as declared and the results meet specification.
7.1.12 General Housekeeping and safety measures shall be observed.
7.1.13 A closing meeting shall be conducted and the vendors shall be briefed about their requirements and their overall performance.
7.1.14 A vendor Audit report shall be prepared and submitted to Head of Quality for his comment along with Vendor Audit Summary Report (Form no. GE023-03)
7.1.15 The Audit Report along with summary report shall be sent to Purchase Manager for his comment. Purchase Manager shall return it to Quality Assurance Department
7.1.16 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
7.1.17 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.
7.2 Vendor for Raw Material
7.2.1 ‘Vendor Questionnaire’ (Form no. GE023-01) shall be send to the vendor for their response.
7.2.2 The filled ‘Vendor Questionnaire’ and the sample test results with related documents shall be reviewed. The related documents are:
– Vendor’s brochure
– Analytical Procedure & COA
– Stability data as per ICH guideline
– Drug Master File (open part if available) etc.
7.2.3 The vendors’ performance shall be reviewed item wise once in a year by scrutinizing the past analytical records.
7.2.4 A program shall be chalked out to audit the vendor (where possible) following steps 7.1.2 to 7.1.17
7.2.5 The vendor shall be informed about their performance evaluation.
