Supplier Certification Program - GMP SOP
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.
Table of Contents
1. Regulatory Basis, Reference Documents
4. Responsibilities and Accountabilities
4.1 Purchasing Department
4.2 Quality Department
5.1 Supplier Approval
5.2 Supplier Qualification
5.3 Supplier Certification
5.4 Reduced testing regime
Attachment 1: Supplier Status List
Attachment 2: Supplier Qualification Change Control Sheet
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- Change Control System - GMP SOPRegular Price $120.00 Today $99.00+ 19% german VAT when applicable
- Pre Approval Inspection - PAI - Free GMP SOP
- Corrective and preventive action (CAPA) - GMP SOPRegular Price $120.00 Today $99.00+ 19% german VAT when applicable
- Deviations (Failure Investigations, Non-Conformance) - GMP SOPRegular Price $95.00 Today $79.00+ 19% german VAT when applicable