Receiving the Complaint
Companies must provide open channels through which customers
can raise their complaints. For example, P.O. box numbers or email IDs, or
toll-free numbers for complaint filing must be publicized. The company must
appoint a person who will be responsible for receiving the complaint and
documenting it as per company requirements.
Technical Examination and Investigation of the Complaint
Once the complaint has been received, a complaint
investigation form should be prepared with the following information.
• Name and contact details of the complainant,
• Details of the drug product on which the complaint has
been raised – product name, manufacturing batch number/lot number,
manufacturing and expiry dates, the quantity of product where the problem is
seen, and
• Details of the nature of the complaint – what exactly is
wrong and has been complained about.
Product complaint data sheet details:
• Serial number of complaints.
• Complaint details.
• Name and address of the complainant.
• Date of receiving complaint.
• Name of the person who received the complaint.
• Details of product involved – name, strength, batch
number.
• Size of the sample obtained from the person raising a complaint.
• Complaint evaluation report.
• Name and signature of investigators with date.
• Action taken report.
• Copy of written response sent to the complainant.
Complaints may be classified as:
(a) Product quality complaints (non-therapeutic) – to be
investigated within 5 days.
(b) Packaging complaints (packing error/shortage) – to be
investigated within 10 days.
(c) Medical complaints (therapeutic) – to be investigated
within 3 days.
This information is sent to the Quality Assurance (QA)
department to start an investigation. A QA Officer is appointed as a Complaint
Officer to oversee the next stages. Two phases of investigation will follow:
first, a document-based investigation, and next, a laboratory analysis.
Document-Based Investigation
This involves a review of
(a) Complaint files to see how many previous complaints of a
similar nature have occurred, and how the complaints were handled.
(b) Batch manufacturing and packaging records to check for
any incidents of non-conformance during that particular batch’s processing.
Laboratory Analysis
This phase involves an analysis by the Quality Control (QC)
laboratory. The samples received with the complaint as well as the samples that
have been retained by the manufacturer must be tested and the results must be
documented.
The Complaint Officer compares the results of the laboratory
analysis and the document-based investigation and prepares a report that may
result in one of three conclusions:
1. Confirmed complaint: When out-of-specifications
(OOS) results are seen in both complaint and retained samples or in only
complaint samples. For example, if both samples of tablets showed discoloration;
or one tablet is missing from the blister pack in the complaint sample but not
in the retained sample.
2. Non-confirmed complaint: When both complaint and
retained samples test results comply with specifications or if only the complaint
sample shows OOS results. For example, tablets in complaint samples are discolored
but this is not seen in retained samples. This could be attributed to improper
storage of the drug at the point of sale.
3. Counterfeit/tamper suspicion: When the retained
sample meets specifications but the complaint sample results are OOS, with no
possible reason to explain the deviation. For example, if the packing material
in the complaint sample is different from that of the retained sample, it could
indicate a counterfeit drug. If the color of the complaint sample drug is different
from the retained sample drug, it may indicate tampering.
The Complaint Officer must also investigate if the complaint
involves any unexpected or serious adverse drug reaction.
After completion of the investigation, generally within 30
days of receiving the complaint, the report is prepared and signed by the Complaint
Officer and QA Manager.
The complaint file must be maintained for at least one year
following the expiry date of the concerned product batch.
Corrective Measures and Giving Feedback to Complainant
In case of confirmed complaints, the company must implement
corrective actions depending on the severity of the problem. In simple cases,
it may be sufficient to impart training to employees; in more complex
situations, it may call for launching a Corrective Action and Preventive Action
(CAPA) by putting together a team of representatives from Production, QC, QA,
and higher management areas.
In case of non-confirmed complaints that may have originated
from improper handling of the product, the company must send a written response
to the complainant, including information on the correct method of handling the
product. The customer may also be sent a free replacement product along with
the response letter.
In case of complaints about serious therapeutic problems or
adverse drug reactions in a significant number, the company may decide to opt
for a product recall if they foresee a considerable risk in the continued sale
of the drug.
Trend Analysis
All complaints received must be analyzed and a trend
analysis must be performed, to collect relevant information. Some of the areas
to be investigated include – how many complaints were received? How many were
confirmed, non-confirmed, and counterfeit/tamper suspicions?
The complaint file along with the trend analysis reports
must be kept available for perusal during cGMP (current Good Manufacturing
Practices) audits/inspections.
Complaint files must be maintained for a minimum of one year
after the expiry of the drug product or one year after the date of receiving
the complaint, whichever is longer. For Over the Counter (OTC) products where
there is no expiry date, the files must be maintained for at least 3 years
after the product’s distribution.
In case of complaints where an investigation was not
performed, the file must record this along with the reason for not performing
the investigation. This record must also indicate the name of the person who
took this decision to not investigate the complaint.