Follow
Any market complaint received or to be raised by marketing / sales team shall be filled up in the market complaint form along with complaint details (Attach original complaint document if applicable). If the details of the complainant are not available in the document then the details of the chemist shop or recipient from where the complaint has been received will be recorded in the market complaint form.
Customer complaints which are received by marketing department or complaint raised by marketing department shall be forwarded to Head of Quality with appropriate details in the market complaint form.
Head of Quality shall send the complaints along with complaint sample, if received, to the QA Manager.
QA Manager shall arrange the investigation and generate a comprehensive report on the customer complaints.
In some instances, complaints with regard to quality of product or other technical related issues shall be received by Head of Quality directly. In such cases, step 6.5 or 6.6 shall be followed and the Marketing department shall be informed immediately. In case of adverse drug reaction complaint follow the procedure for adverse drug reaction.
Investigation of complaints
QA manager shall record the complaint in a compliant logbook. This detail should include a complaint number, name of the product, batch No., Mfg. date, Expiry date, nature of the complaint, name & address of complainant and date of receipt at the investigating site.
QA shall assign a distinct control number to every complaint as follows:
MCR/10/001
Where,
MCR – Market Complaint Report.
10’ represents the last two digits of the year 2010
“001’ represents for serial number of the market compliant report, which starts from
001 for the calendar year.
If complaint sample is received along with the complaint, the investigator shall record the quantity of sample received in the market complaint investigation form.
If no complaint sample is received along with the complaint, the investigator shall record the relevant details disclosed in the complaint form.
QA Manager shall carry out the detailed investigation of the market complaint under the supervision of the Head of Quality to find out the root cause of the complaint and to generate corrective & preventive actions. In his / her absence, Head of Quality shall nominate any other person to carryout activity in this regard.
Investigator shall carefully inspect and record the physical appearance of the sample, seal etc. and compare the details of the references available in documents of the same batch number. Destructive tests or chemical analysis shall be done on the sample at this point of time.
The investigator in consultation with the Head of Quality shall arrange to carry out chemical and / or microbiological analysis of the reference sample (along with the complaint sample, if available) if deemed necessary based on the nature of the complaint to establish the genuineness of the complaint. The investigator must also scrutinize the analytical report of the product under reference.
The investigator shall then discuss the results of the analysis with Head of Production and for the investigation at production end.
The Head of Production along with the respective departmental manager shall investigate the complaint in detail. The investigation should include scrutiny of batch production records for any manufacturing and / or packing problems encountered during the production of the batch. Any equipment breakdowns recorded during production of the batch and any material quality problems faced during manufacturing and packing of the batch also must be studied.
Cognizance should also be given to similar complaint reported in the past and investigation carried out at the time of reporting of those complaints and review of stability studies to be conducted. At the end of investigation the production head shall send a written report, where needed, to the investigator for further investigations.
In case of market complaints following nature, Head of Quality in consultation with MD/ COO may decide to recall the product / batch as per Recall procedure (QA007).
• Product mix up and label mix up
• Failure to meet regulatory specification (i.e. Assay, impurity)
• Adverse drug reaction due to product defect.
• Contamination due to foreign matter. (e.g. Glass pieces, metal pieces, black particles, particulate matter, microbial growth etc)
QA shall record the detailed investigation in market complaint investigation form and response to the market complaint. Reporting and Response to the Market Complaints.
Head of Quality shall prepare the final market complaint response report for products manufactured at site.
The market complaint investigation report should be exhaustive, reveal complete facts of investigation, identify the causes clearly in the best possible manner, may contain corrective action plan by the QA Manager for preventing recurrence of such complaints and also indicate actions already taken if any to prevent recurrence.
The report should be concluded as to whether the complaint is substantiated or non-substantiated. The complaint register must be completed with a brief report of the complaint investigation. The Head of Quality must sign off the complaint report and forwarded to complainant. Copies of the report shall also be distributed to MD, COO, Head of Marketing and Head of Manufacturing.
All records of complaints, reports, corrective and preventive actions taken to resolve the quality problems, responses to the complaints, redressal, complaint register / log etc. shall be maintained by the QA Manager.
Review the complaint, if physical checking of control sample or dockets and a first response/reply is sent to Marketing department within 15 days after receipt of complaint.
Detailed response report after thorough investigation includes complete analysis of control sample (and/or complaint sample) shall be sent.
If a microbiology analysis is required, inform to concern accordingly, regarding time required for analysis and tentative date of secondary reply.
The closure of complaints along with redressal should be completed within 1(one) month period after the receipt of the complaints. Any delays shall be justified.
In case of complaints received from marketing department the Marketing Manager shall attach his note to response report and forward to the complainant. Copy of the same note may also be sent to Head of Quality.
In case of complaint received directly at site, the Head of Quality or the QA Manager shall directly write to complainant and copy to marketing department.
In case of complaint received directly by Beximco Pharmaceuticals Limited (contract acceptor) a communication to the contract giver to be maintained about the received product complaints. A copy of the investigation report should then also be forwarded to the contract giver for contract manufactured products.
Complaint redressal
Head of Marketing after consultation with COO should appraise the customer on the corrective actions taken and on the redressal actions, wherever necessary and a copy of such shall be forwarded to Head of Quality for his reference.
Management reviews of complaints
The Market complaint report, the trends, effectiveness of the corrective actions etc. shall be summarized and reviewed in management review meeting.
