Complaint Handling - Customer Complaints

In stock

This Standard Operating Procedure (SOP) describes the Complaint Handling program, all necessary steps, starting from the notification recording, investigation and subsequent actions, which must be carried out for any customer complaint received.

Complaint Handling and Customer Complaints SOP



This procedure covers all products, which are manufactured and or released by the company. All quality complaints whether verbal or in written must be recorded according to this SOP. Complaints records should be reviewed regularly for any indication of specific or recurring problems requiring attention and possibly the recall of marketed products.



Regulatory basis, reference documents´╗┐


  • 21 CFR Part 211.198, Complaint files
  • EudraLex Volume 4, Part 1 Chapter 8 Complaints and Product Recall



Table of Content (just Headers):


1          Purpose

2          Objective

3          Regulatory basis, reference documents

3.1       Company Management

3.2       Quality Management Representative / Quality Assurance

4          Related documents

5          Definitions

6          Procedure

6.1       Complaint categories

6.1.1    Commercial Complaints

6.1.2    Product Technical Complaints (PTC)

6.1.3    Adverse Drug Event (ADE) Complaints

6.2       Complaint Investigation

6.3       Complaint Investigation details

6.3.1    Complaint information          

6.3.2    Complaint registration

6.3.3    Complaint Tracking and follow up

6.3.4    Complaint final decision

6.3.5    Complaint response

6.3.6    Document complaint compiling and retention

6.3.7    Complaint Trending

6.4       Quality control

6.4.1    Testing of complaint samples

6.4.2    Reserve Samples / Retention sample

6.4.3    Report of test results

7          Attachments

7.1       Attachment 1: Complaint Investigation Form (5 pages)

8          SOP distribution

9          Health, safety and environmental considerations



Size and Format:


    Microsoft Office 2003

    Word File

    14 pages procedure

Write Your Own Review
You're reviewing:Complaint Handling - Customer Complaints