Supplier Approval, Qualification and Certification SOP

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Supplier Approval, Qualification and Certification SOP

This Standard Operating Procedure (SOP) describes the program necessary to ensure qualifying a supplier is to assess the supplier’s reliability, continuous quality of products and services and the overall effectiveness of the supplier’s quality assurance system. This SOP describes the complete process in a step-by-step approach to qualify a supplier from an approved to a certified status.



This SOP is applicable to all GxP manufacturing and quality operations including development processes manufacturing clinical trail materials, toxicity testing and stability studies as well as to the personnel who are responsible for conducting Supplier certification.

This procedure pertains to any supplier that provides raw materials, intermediates, packaging materials and components that are subject to GMP manufacturing, or could have a direct impact upon the quality of a medicinal product or medical device in development, registered or marketed.


Regulatory basis, reference documents

  • 21 CFR 211 Section 211.84
  • EU GMP Chapter 7


Table of Content: 

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Quality Assurance

4.3       Quality Control Department

4.4       Procurement Department

5          Related documents

6          Definitions

7          Procedure

7.1       Supplier Qualification and Certification Program (general)

7.2       Supplier Approval (Step I)

7.3       Supplier Qualification (Step II)

7.4       Supplier Certification (Step III)

7.5       Reduced Testing

8          Attachments

8.1       Attachment 1: Supplier Status List

8.2       Attachment 2: Supplier Change Control Sheet

9          SOP distribution

10        Health, safety and environmental considerations


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 11 pages procedure
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