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Despite all precautions taken by a manufacturer, there is always the likelihood that some problem is present in a given drug product. At such times, customers are likely to find fault with either the content or the packaging of the product, and this dissatisfaction is conveyed in the form of a complaint.
These complaints must be investigated, and corrective actions are taken to deal with the complaints as well as any underlying problems responsible for the conditions that lead to the complaint. All pharmaceutical manufacturers are required to have a complaint handling system to address such issues.
There must be written procedures that describe how to handle all oral and written complaints about a drug product. These procedures must lay down the actions to be taken in the event of receiving a complaint.
Steps in Complaint Handling
The process of handling complaints may be studied under the following headings:
1. Receiving the complaint
2. Technical examination and investigation of the complaint
3. Corrective measures and giving feedback to the complainant
4. Trend analysis
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 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 complaining about.
Product complaint datasheet details:
- A serial number of the complaint.
- Complaint details.
- Name and address of the complainant.
- Date of receiving the complaint.
- Name of the person who received the complaint.
- Details of product involved name, strength, batch number.
- Size of the sample obtained from person raising a complaint.
- Complaint evaluation report.
- Name and signature of investigators with a 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 Complaint Officer to oversee the next stages. Two phases of the investigation will follow: first, a document-based investigation, and next, a laboratory analysis.
This involves the 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.
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 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 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 complaint sample shows OOS results. For example, tablets in the complaint sample 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 retained sample meets specifications but 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. Or if the color of the complaint sample drug is different from 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 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.
All complaints received must be analyzed and a trend analysis must be performed, 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 till a minimum of one year after the expiry of the drug product or till one year after the date of receiving the complaint, whichever is longer. For Over 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.
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