Supplier Audit Program - GMP SOP
Regular supplier audits must be performed to assess the effectiveness of suppliers’ quality assurance systems and to ensure that suppliers meet the requirements of cGMP. The comprehensive testing of pharmaceutical goods is no substitute for an efficient site supplier audit program.
This Standard Operating Procedure (SOP) deals with suppliers involved in activities such as contract manufacturing, packaging/labelling operations, analytical/microbiological laboratory testing, stability testing and general cGMP facilities.
The 16-page Standard Operating Procedure (SOP) guides you step by step through the essential key processes of pre-audit activities, the audit itself and post-audit activities. It describes the responsibilities of the lead auditor, the audit team and the party subject to the audit and also includes a general audit scheme quoted directly from the “Food and Drug Administration Compliance Program Guidance Manual Program”.
Attached to the Standard Operating Procedure (SOP) is an audit report form reflecting all the details needed for a common industry audit report. This SOP template only needs a small amount of site-specific modification before it can be adopted for your operations.
Table of Content
1. Regulatory Basis, Reference Documents
3.1 Types of Audits
3.1.1 Audits of new suppliers / Due Diligence
3.1.2 Regular Audit
3.1.3 Re-approval Audit (Timed Cycle)
3.1.4 For Cause Audit
4. Responsibilities and Accountabilities
4.2 Audit Cycles
5.1 Pre Audit activities
5.1.1 Planning of a new supplier Audit
5.1.2 Supplier’s Response to the Audit Questionnaire
5.1.3 Common Pre-Audit Activities
5.1.4 Audit team
5.1.5 Audit Agenda
5.2 Performing the Audit
5.2.1 The Audit
5.2.2 Final wrap up meeting
5.2.3 Conflict Resolution
5.3 Post audit activities
5.3.1 Audit Report
5.3.2 Conclusion of the Audit
5.3.3 Supplier approval categories
5.3.4 Audit Closure
5.3.5 Records Retention
8. FDA System Overview Checklist
8.1 Quality Systems
8.2 Facilities and Equipment System
8.3 Material Systems
8.4 Production System
8.5 Packaging and labelling System
8.6 Laboratory control System
9. Attachment I: Audit Report Form
Summary of Results
|SKU||Supplier Audit Program - GMP SOP|
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
Here's how it works: Download your copy of this document and if for any reason your aren't completely satisfied after SEVEN ENTIRE DAYS just give us a call, and we'll personally guarantee you get a complete refund.
- PAI Protocol For Drug Products - GMP ChecklistRegular Price $240.00 Today $209.00+ 19% german VAT when applicable
- Supplier Certification Program - GMP SOPRegular Price $90.00 Today $79.00+ 19% german VAT when applicable
- Technical Quality Agreement For Contract Manufacturing (Technical Agreement, Quality Agreement)Regular Price $470.00 Today $397.00+ 19% german VAT when applicable
- Contract testing laboratory - quality questionnaire - GMP Quality ContractRegular Price $240.00 Today $197.00+ 19% german VAT when applicable