How the market complaints are handled in Quality control department
In order to protect public and animal health, a system and appropriate procedures should be in
the place to record, assess, investigate and review complaints including potential quality defects,
and if necessary, to effectively and promptly recall medicinal products for human or veterinary
use and investigational medicinal products from the distribution network. Quality Risk
Management principles should be applied to the investigation and assessment of quality defects
and to the decision-making process in relation to product recalls corrective and preventative
actions and other risk-reducing actions.
Appropriately trained and experienced personnel should be responsible for managing
complaint and quality defect investigations and for deciding the measures to be taken to
manage any potential risk(s) presented by those issues, including recalls. These persons
should be independent of the sales and marketing organization unless otherwise justified.
Sufficient trained personnel and resources should be made available for the handling,
assessment, investigation, and review of complaints and quality defects.
There should be written procedures describing the actions to be taken upon receipt of a
complaint. All complaints should be documented and assessed to establish if they
represent a potential quality defect or other issues.
There should be procedures in place to facilitate a request to investigate the quality of a
a batch of a medicinal product in order to support an investigation into a reported suspected
When a quality defect investigation is initiated, procedures should be in place to address at
least the following:
i. The description of the reported quality defect.
ii. The determination of the extent of the quality defect.
iii. The need to request a sample, or the return, of the defective product from the
complainant and, where a sample is provided, the need for an appropriate evaluation
to be carried out.
iv. The assessment of the risk(s) posed by the quality defect, based on the severity and
extent of the quality defect.
v. The decision-making process that is to be used concerning the potential need for riskreducing actions to be taken in the distribution network, such as batch or product
recalls, or other actions.
vi. The assessment of the impact that any recall action may have on the availability of
the medicinal product to patients/animals in any affected market, and the need to
notify the relevant authorities of such impact.
vii. The internal and external communications that should be made in relation to a quality
defect and its investigation.
viii. The identification of the potential root cause(s) of the quality defect.
ix. The need for appropriate Corrective and Preventative Actions (CAPAs) to be
identified and implemented for the issue, and for the assessment of the effectiveness
of those CAPAs.
This should be followed by,
Investigation and Decision-making
The information reported in relation to possible quality defects should be recorded,
including all the original details.
Root Cause Analysis and Corrective and Preventative Actions
An appropriate level of root cause analysis work should be applied during the investigation of quality defects.
Appropriate CAPAs should be identified and taken in response to a quality defect. The
effectiveness of such actions should be monitored and assessed.
Quality defect records should be reviewed and trend analyses should be performed
regularly for any indication of specific or recurring problems requiring attention.
Reference: EUDRALEX- Volume 4
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Part 1, Chapter 8: Complaints, Quality Defects and Product Recalls