Phone +49 7621 76176 Mo - Fr 9.00 - 17.00 (GMT)
Standard Operation Procedures

Supplier audit program

Updated Version
Standard Operation Procedures
85,00 EUR
app. 112.20USD
(Non-german customers)

101,15 EUR
(German customers incl. 19% tax)

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.
GMP Money Back Guarantee
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.

Description of the Standard Operation Procedures - Supplier audit program

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
2. Purpose
3. Scope
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
4.1 Responsibilities
4.2 Audit Cycles
5. Procedure
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
6. Definitions
7. Distribution
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
Audit Report
Audit Observations

Supplier audit program
85,00 EUR
Additional 19% tax for customers from Germany
Customers who bought this item also bought:
Product Recall
120,00 EUR
19.82% also purchased this product.
Pest control program
95,00 EUR
17.12% also purchased this product.
Handling of chemicals, reagents and solutions in laboratories
50,00 EUR
15.02% also purchased this product.
Handling of OOS results
100,00 EUR
10.21% also purchased this product.
NDA field alert
100,00 EUR
8.71% also purchased this product.
Validation master plan drug substance manufacturing (API)
170,00 EUR
7.21% also purchased this product.
Site master file (SMF) for API - drug substances
245,00 EUR
5.41% also purchased this product.
PAI protocol for API
195,00 EUR
3% also purchased this product.
SOP for refrigerated shipment
85,00 EUR
2.7% also purchased this product.
Contract manufacturer solids - contractor quality questionnaire
210,00 EUR
1.8% also purchased this product.
Product Recall
120,00 EUR

eCommerce Engine © 2006 xt:Commerce Shopsoftware