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Supplier certification program
Standard Operating Procedure

Updated Version
  Description:
The aim of the supplier certification program is, firstly, to ensure that all products and services necessary for GMP operations consistently meet your acceptance criteria and, secondly, to enable you to implement a reduced testing regime for incoming goods. This Standard Operating Procedure (SOP) is applicable for all suppliers that provide raw materials, intermediates, packaging materials and components that are subject to GMP manufacturing processes.

Using a step-by-step approach, this procedure describes all the measures that need to be taken to certify a supplier. This Standard Operating Procedure (SOP) covers all key processes in supplier certification, starting with supplier approval, then subsequent steps toward becoming a qualified supplier and, finally, achieving certified status. This supplier certification program will result in increased customer satisfaction, accurate and up-to-date supplier records, a better understanding of your partners, mutually beneficial partnerships and improved product and service quality.

The 8-page SOP, which includes two attachments – a supplier status list and a supplier qualification change control sheet – is ready to use and only needs a small amount of site-specific modification.
 
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  Price: 79.– EUR *
(appr. 102.- USD)
Add to cart  
* additional 19% tax for customers from germany / no shipping costs will be charged

  Delivery item:
  Icon Open Word Document*
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
  Further details of this Standard Operation Procedure:

Table of Contents of this Standard Operating Procedure:

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Purchasing Department
4.2 Quality Department
5. Procedure
5.1 Supplier Approval
5.2 Supplier Qualification
5.3 Supplier Certification
5.4 Reduced testing regime
6. Definitions
7. Distribution
8. Attachments
Attachment 1: Supplier Status List
Attachment 2: Supplier Qualification Change Control Sheet





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