This Standard Operating Procedure (SOP) describes the program necessary to ensure suppliers effectiveness of their quality assurance system and to ensure that the requirements of the Good Manufacturing Practice (GM) are being met by independent Audit. It assesses supplier’s reliability as well as continuous quality of products and services.
The purpose of this document is to provide clear guidance for Quality and GMP personnel conducting Audits of suppliers, contract manufacturing, packaging/labeling operations, analytical/microbiological laboratory testing, stability testing and general GMP facilities.
Regulatory basis, reference documents
- 21 CFR 211 Section 211.84
- EU GMP Chapter 7
- Guide to Good Pharmaceutical Manufacturing Practice 1983.
- Code of Federal Regulations, Food and Drug, 21.211.
- EEC Guide to Good Manufacturing Practice for Medicininal Products, 1989.
- Article 14 of the EU directives on GMP (91/356/EEC and 91/412/EEC).
Table of Content (just Headers):
3 Regulatory basis, reference documents
4 Responsibility and accountability
4.1 Company Management
4.2 Quality Assurance
4.3 Procurement Department
5 Related documents
7.1 Different Types of Audit (general)
7.1.1 Audits of new suppliers / Due Diligence
7.1.2 Regular Audit
7.1.3 Re-approval Audit (Time Cycle)
7.1.4 For Cause Audit
7.2 Audit cycle time
7.3 Pre Audit (preparation) activities
7.3.1 Planning of a new supplier Audit
7.3.2 Supplier’s Response to the Audit Questionnaire
7.3.4 Common Pre-Audit Activities
7.3.5 Audit team
7.3.6 Audit Agenda
7.4 Performing the Audit
7.5 Post Audit activities
7.5.1 Audit Report
7.5.2 Conclusion of the Audit
7.5.3 Supplier Approval Categories
7.5.4 Audit closure
7.5.5 Record Retention
8.1 Attachment 1: FDA Audit Checklist (6 pages)
8.2 Attachment 2: Audit Report Form (3 pages)
9 SOP distribution
10 Health, safety and environmental considerations
Size and Format:
- Microsoft Office 2003
- Word File
- 21 pages procedure