SOP for Handling of market complaints in pharmaceuticals | Handling of market complaints in pharmaceuticals |
- Handling of Market Complaints SOP covers below points:
- how to handle market complaint in pharma industry
- Handling of Market Complaints procedure
- Complaint capture and processing
- Complaint management
- Corrective Action Plan
- Complaint resolution and closure
- Retention Of Complaint Test Samples
- Complaint Report format
- Complaint Register format
- Product Complaint Form format
1.0 OBJECTIVE :
- To establish a procedure to investigate, document, respond and review of all product related complaints.
2.0 SCOPE :
- This procedure applies to all the market complaint of products received from various agencies such as Drug regulatory bodies, customers, field force, mail etc and adverse reactions reported by doctors, licensing authorities.
3.0 RESPONSIBILITY :
- Receiver : To receive the complain from customer, licensing authorities, field force etc and forward to Quality Assurance Head. The receiver may be marketing, commercial or administration department.
- Quality Assurance Head: Logging the Complaint in complaint register, carry out the investigation with the help of the respective department head, recommend the corrective action, send the reply to complaint.
- Head of Department: Help Quality Assurance head to carry out the investigation.
- Head Technical: To evaluate the Complaint investigation form and fix the responsibilities of corrective action as recommended by Quality Assurance head by coordinating with concerned individual.
4.0 ACCOUNTABILITY:
- Q.A. Head
5.0 PROCEDURE :
5.1 Product complaint is a information regarding any product defect, purity, labeling defects, shortage or dissatisfaction of customer. Complaint can be from doctors, clinics, hospitals, paramedics, pharmacies, dealer, government agencies, regulatory bodies and customers. It can be of two forms like verbal or written like mail, letter etc. The verbal complaint must be documented by receiver.
5.2 Complains shows customer (consumer, prescriber, regulator and other stakeholder) dissatisfaction about the quality of product and is an indicator of potential source of danger or concern after distribution or sale.
5.3 All the concerned function like marketing, production, quality control, warehouse, distribution are involved in investigation.
5.4 After receipt, all such complaint shall be sent to Quality Assurance head or designee for investigation along with sample, if any. The receiver must acknowledge the complaint to sender.
5.5 The procedure consists of five parts viz.
5.6 Complaint capture and processing:
- All complaint (written, verbal, telephonic or E-mail) received directly are forwarded to Quality Assurance Head or designee to initiate the investigation.
- The quality assurance department will file the complaint in register with reference number (MC/YY/XXX).
- Where,
- MC : Market complaint
- YY : Current year i.e.22
- XXX : Serial number,
- e.g. First complain of 2022 year will have the number as MC/22/001.
- Under the supervision of Quality Assurance head or designee, the officer/chemist or above of quality assurance department will perform investigations by root cause.
5.7 Complaint management:
- Observation and Investigation:
- The investigation is divided into two parts as documentation based and laboratory based (Quality Control).
- Document based investigation consist of review of raw material testing reports, review of batch records of complaint batch, In process Testing report, finished goods testing reports, Stability review etc.
- Laboratory based investigation is to reanalyze the complaint sample along with control sample and review of data. In case of complaint sample is not received only control sample is to reanalyzed and data compared. Analyze the sample on same specifications on which product was approved initially.
- Test parameters to be performed for the complaint sample are to be specified by Quality Control head or designee. After completion of analysis, Quality control Head or designee has to send the report of analysis to Quality Assurance Head or designee for further investigation.
- The complaint report should contain the following (Refer Annexure No. 01).
- Name and address of the complaint.
- Complaint number.
- Complaint received from and complain received on.
- Product detail with product pack batch number manufacturing and expiry date.
- Detail of complaint with unique complaint number.
- Nature of Complaint.
- Findings by production/Quality Control/ Quality Assurance.
- Conclusion
- Action to be taken
- CAPA
- Signatories with Department
- Quality Assurance Head or designee shall observe the complaint sample and control sample and investigate nature of the complaint. Classify the complaint as Critical/Major/Minor depending upon nature of the complaint & inform to Director/Technical Head.
- Critical : Complaint regarding Product stability / quality
- On the consumption of the drug either the reaction is adverse or death of the patient or it is ineffective. In this case stop consumption or sale & recall shall be immediate.
- Major: Complaint regarding primary Packing
- Spots, sealing defects etc. are major complaint.
- Minor : Complaint regarding secondary Packing
- Labeling defect, quantity less, number of tablets less are minor complaint.
- Quality Assurance Head or designee coordinates all the activities with marketing department till the complaint is closed.
- In case of Critical Complaint: The batch shall be recalled (Refer Product Recall SOP) and shall follow procedure for recall, handling and destruction.
- Quality Assurance Head or designee shall carry out the detailed investigation, check the control sample of the complaint batch & should get re-analyzed with the complaint sample (if received with complaint) by using a current version of specification used for the routine testing of the product.
- Also the Quality Assurance Head or designee should recheck the BMR/BPR of that batch & also preceding & succeeding batch to confirm that the operation of manufacturing & the packing were performed as per SOPs & GMP norms as part of investigation.
- Quality Assurance Head or designee has to consult (as per requirement) with Technical Head/ Marketing/ Production for necessary investigation at their end. Appropriate action is to be chosen from the following, depending on the nature of the complaint:
- In case of Major Complaint: the batch shall be handled as per SOP for Handling of Return Goods:
- If the Complaint are other than the product quality, the Quality Assurance Head or designee sends a photocopy of the original complaint along with the sample ( if available) to the respective department head for investigation.
- The department head check the respective record of the complaint batch, (Quality Control head or designee check the Analytical report with Raw data, Production head check the BMR & BPR etc.) as per the nature of the complaint & report to Quality Assurance Head or designee for necessary action if any discrepancies observed.
- In case of Minor Complaint: Investigation and corrective action plan is indicated below:
- Key functionaries involved in the investigation of the complaint are – Quality Assurance Head Depending upon the nature of complaint, other Head of Department (e.g. production, Quality Control) are involved in the investigation and corrective/preventive actions are planned and authorized by Quality Assurance Head or designee. The concerned person from production / quality control shall be involved as part of preventive measures.
- Quality Assurance Head or designee follows up for the implementation of planned corrective and preventive actions.
- The investigation is divided into two parts as documentation based and laboratory based (Quality Control).
5.8 Corrective Action Plan :
- Quality Assurance Head or designee assesses the effectiveness of planned and implemented corrective/preventive action. This is done to prevent the possibility of repetition of the problem.
- All communication from factory to marketing shall be done by Quality Assurance Head or designee.
- All discussion/communication with the customer are done through Marketing Department /Director. The Director & customer are informed about the status of investigation and corrective action/ observation.
5.9 After approval of CAPA, with the signatories of production, Quality control and Quality Assurance, Quality Assurance head or designee will handed over the report to Technical Head for review.
5.10 Complaint resolution and closure:
- After receiving the analytical results and after performing the documentation based investigation, the Quality Assurance Head or designee will be able to conclude the investigation. There are three possible conclusion as below;
- Confirmed Complaint: When both complaint and control samples showed Out Of Specification (OOS) results or when only complaint sample showed OOS results, the complaint is classified as CONFIRMED. A missing tablet in Blister/ Strip will also be concluded as confirmed, even when OOS is not initiated.
- Non-confirmed Complaint : When both complaint and control samples showed result in compliance with specification or when only complaint sample showed OOS results, that cannot be considered a single unexplained failing product. OOS results in complaint sample can be attributed to misuse or mishandling, when the product was not stored under appropriate conditions. An example of non-confirmed sample may be when the tablets of the complaint sample show a change in appearance, which is characteristic of exposure to adverse conditions. This type of complaint is classified as Non-confirmed.
- Counterfeit/ Tamper Suspicion: When the control sample is within specifications but the complaint sample is clearly OOS with no reason for that. This is an example of counterfeit or tampered products e.g. when the packaging material is different from the original, colour of product is completely different from the original.
- On the completion of the Investigation, the Quality Assurance Head or designee shall fill the Complaint Register (Refer Annexure No. 02) containing the details like Complaint received from/on complaint number, detail of product, Investigation completion date, actions taken to avoid the complaints of same nature in future, status of complaints & take the signature of the Quality Assurance head or designee.
- Investigation shall be completed within 3 weeks.
- Simultaneously Quality Assurance Head or designee also fill the Product Complaint Form (Refer Annexure No. 03) containing details like Product Name, Complaint received from, Complaint received on, Reference Complaint number, Batch No., Manufacturing & Expiry date, Complaint Quantity, Number of Cartons/Corrugated box, Nature of the Complaint, Distribution record of the Complaint batch, Whether any complaint is received for the same batch from any other customer, Analysis of Complaint Sample & Control sample (if applicable), External & Internal Investigation details, Conclusion, cause of Failure & necessary Corrective actions etc. to keep the track of the complaint received for the individual product.
- The period for closing of the complaint depends upon the nature of complaint, the type of corrective and preventive action planned and the time required for the effective implementation of the same.
- After reviewing the corrective actions and the results obtained, the Quality Assurance Head or designee, Quality Control Head, Technical Head, Director and Marketing shall decide on the closing of the complaint. The investigation report may be given to customer along with proposed action. The customer is requested to reply within one month as regards to their satisfaction with proposed action. In case no communication is received from the customer in the said time period the complaint shall be deemed closed.
- Review of customer complaint is done once in every six months by Quality Assurance Head & Quality Assurance Officer/Chemist.
5.11 Retention Of Complaint Test Samples:
- The complaint unused sample including packaging, at their labeled storage conditions will be retained under custody of Quality Assurance Department for minimum of 90 days period after the investigation. Apart from this, the retention of samples is initiated at cases such as; Complaint referred to/received from Regulatory authorities, Samples collected by Drugs Inspectors, Complaint forwarded by principal/Loan licensor and / or received from customer, where the Complaint has expressed the intentions to take the issue to the Regulatory authorities.
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| SOP | Standard Operating Procedure |
| GMP | Good Manufacturing Practice |
| OOS | Out of Specification |
| BMR | Batch Manufacturing Record |
| BPR | Batch Packing Record |
| GEN | General |
7.0 ANNEXURES:
| Annexure No. | Title |
| 01 | Format for Complaint Report |
| 02 | Format for Complaint Register |
| 03 | Format for Product Complaint Form |
8.0 SOP REFERENCES
- WHO GMP Guidelines
END OF THE SOP
ANNEXURES :
Annex. No. 01 Format for Complaint Report
Annex. No. 02 Format for Complaint Register
Annex. No. 03 Format for Product Complaint Form
