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

Word File

14 pages procedure

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