General
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
- Word File
- 11 pages procedure
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