SOP for Handling of Product Complaint (Customer Complaint or Market Complaint)
1.0 OBJECTIVE
To lay down the procedures for receipt, investigation, evaluation, reporting and closure of the Product Complaints received in written or verbal.
2.0 SCOPE
The scope of this standard operating procedure (SOP) is to provide the system for receipt, investigation, documentation, and closure of Complaints received through Corporate Quality Assurance (CQA), Regulatory Agency, Depots, marketing, drug stores or directly from customers to Quality Assurance Department at [Company Name].
3.0 RESPONSIBILITY
Quality Assurance (QA) personnel – to investigate complaint.
Head QA or his designee – Evaluation of complaint. In coordination with other Concern Head of Departments or his designee
4.0 PROCEDURE
4.1 The product complaints shall be categorized as follows:
4.1.1 “CRITICAL”
This category covers Complaints about defects, which directly affects quality, safety, purity, identity and strength of the product and makes the product unsafe for consumption. Eg. Complaints of product mix up, adverse drug reactions, if drug declared as spurious drug that has caused or has been found to have potentials to cause serious health hazards and If the drug found to produce pharmacological reaction other than it purports to do.
4.1.2 “MAJOR”
This category covers the complaints about defects, which indirectly affects quality, safety, purity, identity and strength of the product and makes the product unsafe for consumption. Eg. Complaints of missing of batch overprinting details on Product, Batch mix-up, lack of batch trace-ability, failure of product to comply with the finished product specifications and fungal growth in the product during handling.
4.1.3 “MINOR”
This category covers the complaints about the defects that can be noted and corrected by a scheduled program. Eg. Complaints of de-shaped or defaced secondary packaging components, Shortage such as empty pockets, missing blister, missing leaflet.
4.2 The product complaint may further be categorized on the basis of its nature into following:
4.2.1 Quality related,
4.2.2 Process related,
4.2.3 Packaging related,
4.2.4 Short supply related,
4.2.5 Transit and Storage related,
4.2.6 Any other as appropriate.
4.3 On receipt of product complaint, a unique reference number shall be allotted to the complaint in the following manner:
PC/XXX/YY
Where,
PC – Product Complaint
XXX – Serial number of the complaint (Eg. 001 means first complaint of the year)
YY – last two digits of the Year
4.4 The Complaint should be entered in product complaint register as per Annexure – I with following details:
4.4.1 Sr. No
4.4.2 Date of receipt
4.4.3 Reference No.
4.4.4 Product Name & strength
4.4.5 Batch No.
4.4.6 Manufacturing & Expiry date.
4.4.7 Details of Complaint.
4.4.8 Category (Critical/Major/Minor)
4.4.9 Received from
4.4.10 Enclosures
4.4.11 Corrective Action
4.4.12 Preventive Action
4.4.13 Investigation report sent to CQA on date
4.4.14 Sign
4.4.15 Customer Correspondence copy received from CQA on date.
4.5 The complaint received from other than CQA shall be forward to CQA for their record and after recording the complaint at CQA it is represented to site as per the procedure of corporate guideline.
4.6 In case of oral complaint received at site Representative person at site take the complaint & note down the complaint in product complaint register with available details in annexure I & send this information to CQA for their official record.
4.7 The complaints shall be accompanied with suitable evidence or proof or the case may be.
Investigation of complaint:
4.8 The product complaints shall be investigated to identify the root cause. All documents generate while investigation or reporting shall bear the Complaint number for traceability.
4.9 The investigation may include (if require), but not limited to the following as applicable:
4.9.1 Review of Batch records.
4.9.2 Review of Analytical Reports based on the nature of complaints.
4.9.3 Review of Batch records and analytical data of batches manufactured in the same period.
4.9.4 Physical and analytical verification of the retained samples.
4.9.5 If required or on the basis of criticality of the complaint, evaluation of the preceding and succeeding batches, where in the same ingredients / raw materials were used.
4.9.6 Checking the training records of the concerned responsible person and to identify the need for retraining.
4.9.7 Review of trend data of Annual Product Review records.
4.9.8 Review of the stability data.
4.10 The records, Investigation details and findings of the complaints shall be recorded in investigation report as per annexure II.
4.11 Complaints received from drug regulatory authorities may be attended and evaluated as per the directives received from them.
4.12 On identification of the root cause of the complaint, corrective action is to be taken and a preventive action plan is to be prepared and implemented. These actions shall be recorded in CAPA register [Ref. SOP Title: Corrective and preventive actions (CAPA)]
4.13 Prior to sending the investigation report and data to CQA, Head Production and Head QA should evaluate and check it for completeness.
4.14 On completion of investigation, Product complaint investigation report shall be forwarded to CQA for final comment / review and to respond to the customer. The product complaint report shall be sent to CQA along with the investigation report.
4.15 Details of sending the Product Complaint reports to CQA and receiving of customer correspondence copy from CQA shall be recorded in Product complaint Register as per Annexure I and the received customer correspondence copy shall be filed.
4.16 The Implemented corrective and preventive action plans should be periodically checked through internal audits or need based.
4.17 At the end of year, a data for all the product complaints received in the year shall be recorded as per Annexure III. Trend analysis to be performed considering last five year data and comparative trend to review by QA head.
4.18 Product complaint Records shall be reviewed annually for any indication of specific or recurring problems
4.19 In case of repetition of complaints similar in nature for specific product or recurring cause, the matter may be taken up with top management in management review meeting.
4.20 Normally each product complaint shall be replied within 30 working days from the date of receipt.
4.21 In case of delay in sending the response to CQA due to technical reasons like extra analysis, extra stability studies to be carried out, an interim report with suitable justification shall be forwarded to CQA mentioning the tentative date of submission of investigation report.
4.22 In case of the investigation (as the case may be) is not required, written record shall include the reason and justification why the investigation was not required and give the reference of responsible person making such a determination.
4.23 Copy of reply given by CQA to compliance shall be file with complaint docket.
5.0 ANNEXURE (S)
Annexure I – Product Complaint Register
Annexure II – Investigation Report
Annexure II – Trend Data
Annexure I – Product Complaint Register
Sr. No.
Date of receipt
Ref. No
Product Name
Batch No
Mfg date
Exp date
Details of Complaint
Category (Critical / Major / Minor)
Received from
Enclosures
Corrective Action
Preventive Action
Investigation report sent to Corporate QA on
Sign
Customer Correspondence copy received on date
Annexure II – Investigation Report
Product Complaint Reference No.
Mode of Intimation
Date of Receipt
Product
Batch No.
Mfg. Date
Exp. Date
Party
Market
Pack Style
Nature of Complaint
Classification Minor / Major / Critical
Complaint Sample(s) Received / Not Received
Quantity of Complaint Sample
Investigation Started on
Investigation completed on
Complaint History (Details of earlier complaints of similar Nature if any):
Details of Investigation:
Observation of Retain Sample: (Attach analytical reports in case of any analysis is carried out)
Complaint Sample(s)
Retain Sample (complained batch)
Related Samples of other batches
Review of Batch Record:
Following guideline may be followed for investigation:
1. Human Error – List Out and identify personnel involved
2. Machine Related – Check maintenance / machine logs for any break downs, failure and check adequacy of safety systems and controls.
3. Process Related – Check for any deviation / discrepancies / non compliance
4. Material Related – List AR numbers, Source & Check initial test reports
5. Others – Check out other possible causes
Details of Experimental Investigation (If any):
Details of Annual Product Review (if any):
Details of Review of Stability Data (If any):
Summary and Conclusion:
Corrective action taken / planned:
Preventive action taken / planned:
Head Production (Sign & Date)
Head QA (Sign & Date)
(Attach additional sheets, if required.)
Annexure IV – Trend Data
Period:
Categories:
Quality
Process
Packaging
Short supply
Transit and Storage
Critical
Major
Minor
Total Complaints