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SOP For Qualification of Vendors - Pharmaceutical Guidelines
SOP For Qualification of Vendors - Pharmaceutical Guidelines
1.0 OBJECTIVE:
To lay down the procedure for the qualification of vendors for the Raw materials and Packaging materials.
2.0 SCOPE:
This SOP shall be applicable for all the incoming Raw materials and Packaging materials used for Own & Contract manufacturing sites.
3.0 RESPONSIBILITY:
QA Officer / QA Executive
4.0 ACCOUNTABILITY:
Head- QA & QC
5.0 PROCEDURE:
5.1 Procedure for inclusion of vendor in approved vendor list (Raw materials)
5.1.1 New vendors shall be qualified and approved by QA department before regular supply of raw materials.
5.1.2 Purchase department shall locate the new vendor and find out the details of products manufactured supplied by them. In case of existing
materials, Purchase department shall provide specification to the vendor.
5.1.3 In case of RM source, after the initial assessment, Purchase department shall arrange to get the Supplier Questionnaire filled by the supplier.
5.1.4 If the Questionnaire evaluation is found suitable, Purchase department after discussion with R&D and QA shall ask for 3 batches of samples
along with certificate of analysis of in-house & Public Testing Laboratory for quality evaluation and subsequent stability studies.
5.1.5 Purchase department shall arrange to send 3 batches of samples along with New Source Request form to R&D for quality evaluation and
stability testing.
5.1.6 R&D shall send the samples along with New Source Request Form to QA Head for evaluation
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9/11/2019 SOP for Qualification of Vendors : Pharmaceutical Guidelines
5.5 Procedure for Inclusion of Vendor in Approved Vendor List (Packaging Materials)
5.5.1 New vendors must be qualified and approved by QA department before regular supply of packaging materials.
5.5.2 Purchase department shall locate the new vendor and find out the details of products manufactured / supplied by them. In case of existing
materials, Purchase department shall provide specification to the new vendor.
5.5.3 For printed and primary packaging materials, vendor audit is performed by representative of QA department and GMP Cell.
5.5.4 Samples of printed packaging materials if necessary shall be submitted to QA department.
5.5.5 Purchase department after studying the comments of QA department shall inform the supplier for the supply of the material.
5.5.6 Based on the product compliance and assessment, further procurement of packaging material should be continued. On ensuring compliance
with specifications the vendor shall be included in Approved vendor’s list.
5.8 FREQUENCY
List of approved vendors to be prepared once in a two years or as & when required.
6.0 ABBREVIATIONS:
6.1 SOP: Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
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9/11/2019 SOP for Qualification of Vendors : Pharmaceutical Guidelines
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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