SOP for Vendor Audit : Pharmaceutical Guidelines

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SOP for Vendor Audit

Standard operating procedure to conduct audit at vendors manufacturing site to check the manufacturing procedure of the material that vendor supplies.

1.0 OBJECTIVE

Quality of inputs forms a base for product quality. A vendor audit programme is an initial step towards ensuring input quality. This programme will build our confidence for quality of material received from our qualified suppliers.

2.0 SCOPE

2.1 As a part of a vendor audit programme, a facility and system will be inspected periodically and supplier will be qualified accordingly. In case of deficiency in supply, a deficiency related audit may be conducted for a qualified supplier. This will help to identify the problem and will avoid repetition of such failure.

3.0 RESPONSIBILITY

3.1 In charge-Purchase

4.0 ACCOUNTABILITY

4.1 Manager-Quality

5.0 PROCEDURE

5.1 Prepare the list of vendor on the basis of vendor rating analysis.
5.2 Intimate commercial department to audit the vendors and provide them the checklist of ‘vendor audit’.
5.3 Circulate the checklist of Attachment-1 for ‘Audit of Vendor’ to the respective supplier, through commercial dept.
5.4 On receipt of communication from vendors, prepare the audit schedule and hand over to commercial dept.
5.5 Confirm the date of the audit of respective vendors with the help of commercial dept.
5.6 Intimate the vendor regarding confirmation of the audit date.
5.7 Audit the vendor as per the checklist of Attachment-1
5.8 Prepare the audit report & fill the checklist & circulate it to concerned dept. & management.
5.9 Give suggestion/ recommendation to the vendor on the basis of the audit report through commercial dept.
5.10 Follow up with the vendor for suggestion/recommendation.
5.11 Intimate to the concerned location regarding vendor audit and provide vendor audit report and final remark of the approved vendor.
5.12 Plant QA will file the audit report along with vendor rating.
5.13 A team of members constituting members or designee of CQ, location Quality and purchase shall conduct the audit.
5.14 The audit report from other location shall be considered after reviewing.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 CQ: Corporate Quality

Attachment 1Download Vendor Audit Checklist
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