Learn how to write a standard operating procedure SOP for vendor audit (supplier audit) to select vendor or supplier in pharmaceutical.
1.0 PURPOSE
To evaluate a potential new source or to monitor ongoing quality on a routine basis for existing vendors.
2. SCOPE
This SOP is applicable to all vendors manufacturing raw & packaging materials supply to Pharmaceuticals industry.
3. ASSOCIATED DOCUMENTS
SOP for approval of suppliers of inventory material
4.0 RESPONSIBILITY
4.1 Head of Plant is responsible for constituting an Audit team and giving his comment reviewing the Audit Report.
4.2 Head of Quality Assurance or Manager/Executive is responsible for reviewing the Questionnaire of the vendors.
4.3 Personnel of Commercial Department is responsible for sending vendor Questionnaire to national
and international vendors, finalizing the audit program, taking necessary action on vendors after getting the audit report.
4.4 Head of Commercial Department is also responsible to give his comment about customer service on vendor audit summary report.
4.5 Audit Team is responsible for carrying out the Audit Program and preparation and submission of Vendor Audit Report.
5.0 ACCOUNTABILITY
Head of Quality Assurance Department
6.0 PRECAUTIONS
Not Applicable
7.0 PROCEDURE
7.1 Local Vendor
7.1.1 Chalk out a visit program and constitute an audit team.
7.1.2 Inform commercial to finalize the program.
7.1.3 Inform vendor at least one week earlier of the proposed visit date.
7.1.4 Send the ‘Vendor Questionnaire for Packaging Material’ (Annexure-2) to the local packaging material manufacturer and ‘Vendor Questionnaire for Raw and Capsule shell Material’ (Annexure-1) to the Raw and Capsule shell manufacturer.
7.1.5 Cross check the information provided by the vendor in the questionnaire in case of new sources.
7.1.6 Select a batch randomly and check finished product analysis, documentation and approval procedure of the raw material. In case of packaging material select a product and check all the steps of printing operation according to procedure.
7.1.7 Check Quality Control Laboratory facilities for adequacy of testing equipment (if applicable).
7.1.8 Check whether all the tests are carried out as declared and ensure the results meet our specification.
7.1.9 Observe general Housekeeping and safety measures.
7.1.10 Conduct a closing meeting and brief the vendors about their requirements and their overall Performance
7.1.11 Prepare a vendor Audit report and submit to Head of Quality Assurance for his comment.
7.1.12 Send the Audit Report to In-charge Commercial for his comment and return it to Quality Assurance Department
7.1.13 Keep the original copy of the report to Quality Assurance Department and send one photocopy to Commercial Department to take necessary action with the vendor.
7.2 International Vendor
7.2.1 Send ‘Vendor Questionnaire’ (Annexure –1) to international vendor for their response
7.2.2 Review the filled ‘Vendor Questionnaire’ and the sample test results with related documents such as-
Vendor’s brochure
Analytical Procedure & COA
Stability data as per ICH guideline
Drug Master File (if available) etc.
7.2.3 Review international vendors’ performance item wise once in a year by scrutinize the past analytical records.
7.2.4 Chalk out a program to audit the international vendor (where possible) following steps 7.1.2 to 7.1.13.
7.2.5 Inform vendor about their performance evaluation.
8.0 ABBREVIATIONS
8.1 SOP: Standard Operating Procedure
8.2 ICH: International Council for Harmonization
8.3 QA: Quality Assurance
8.4 COA: Certificate of Analysis
9.0 ANNEXURES
9.1 Annexure-1: Vendor Questionnaire for Raw & Capsule Shell
9.2 Annexure-2: Vendor Questionnaire for Packaging Materials
10.0 REVISION HISTORY
| Version | Effective date | Description of the Changes |
Related Topics:
How to Handle Audits in Pharmaceuticals
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the first Bangladeshi pharmaceutical blogger since 2019.
