A complaint is any expression of dissatisfaction with a product or service marketed.

Any written/ genuine verbal communication received directly from any customer, retailer, distributor, healthcare professional, regulatory agency, patient (Consumer) or field staff, regarding the safety, identity, strength, purity, efficacy, quality, shortages or  any other such  complaints shall be considered  as a Market Complaint.

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PROCEDURE:

All the market complaints shall be received by marketing department (Domestic/International) at Head Office.

Concern marketing person shall record all the details of complaint product, name and address of complainant and nature of complaint in “Market Complaint Form and forward the same to Head-CQA.

Head-CQA/Designee shall ensure that all information available in the “Market Complaint Form” concerning the particular complaint. Ensure that all required information is entered and all required information for complaint investigation is received and if not, then Head-CQA shall ask to  send  required information to marketing department.

In case of quality/efficacy related complaint, Head-CQA/Designee shall request the complainant/marketing department for complaint sample. Head-CQA/Designee shall follow up for complaint sample up to 15 days from the date of complaint.

If marketing department is unable to provide the required information (Details of complaint) and complaint sample to Head-CQA then the same complaint shall treated as non-justified complaint and closed.

If the required information provided by marketing department/complainant, Head – CQA shall acknowledge the “Market Complaint Form” by signing on received by column with date and the same shall be forwarded to Head-QA/Designee at site.

Head-QA/Designee shall enter the complaint details in market complaint log

After logging of complaint, Head-QA/Designee shall start the investigation of compliant based on guideline provided

Physical inspection of complaint & control sample.

Review of batch document for,

o  API calculation.

o  Qty. added of API & excipients (dispensing slip/raw material requisition against bill of material.

o Source of material.

o Dispensing precautions: e.g. API dispensing & storage in the dedicated polybag or container etc.

o Processing precautions, low light, and nitrogen flushing or any other.

o Processing parameters.

o In process checks by production & QA.

o Any deviation, which has direct or indirect impact on product quality.

In process quality control data.

Review of FP analytical report & trend.

Review of stability data.

Complaint & control sample analysis for,

o Weight variation, Hardness & friability.

o  Content uniformity.

o  Dissolution.

o  Assay.

o  Degradation.

o  Moisture content.

o  Biological assay.

o Storage condition.

Audit of distributors, C & F agent or retailer etc.

o Minor crack.

o Improper sealing.

o Condition of container label & / or carton to eliminate possibility of leakage.

Review of batch manufacturing record for,

o  API calculation.

o Qty. added of API & excipients (dispensing slip/raw material requisition against bill of material.

o In process checks by production & QA.

o Yield & reconciliation of the batch.

In process & FP quality control data.

Equipment usage logbooks of compression or capsule filing machine for breakdown.

Complaint & control sample analysis for,

o Average weight

o  Dissolution.

o  Content uniformity.

o  Assay.

o Degradation.

o  Weight variation.

Physical inspection of control & complaint sample.

Review of storage condition.

Review of stability data.

Analysis of complaint &/or control sample for,

o  Assay.

o  Degradation.

Physical inspection of complaint & control sample.

Physical inspection of particular AR No. of RM used for manufacturing of the batch.

Review of batch manufacturing record.

Cleaning record of mfg equipments & area.

Environmental monitoring data.

Analysis of complaint sample for,

o  Assay, Degradation.

o  Microbial contamination test.

Training record of visual inspectors.

Review history of the patient.

Review of package insert.

Microbiological analysis of complaint sample.

Pharmacology of the API & related formulations.

/capsules.

Physical inspection of complaint & control sample

Review of batch manufacturing record for,

o  Special precautions required during processing e.g. controlled humidity/ light sensitive & temperature etc.

o  Cleaning record of granulation, compression and coating equipments & area.

o  In process checks by production & QA during manufacturing & packing.

Analysis of control & / or complaint sample for,

o  Assay, Degradation, Stability data

Storage condition.

Review of batch manufacturing record for,

o  Visual inspection record

o  Temp. & humidity conditions

o  Capsule filling machine setting parameters

o  In process checks during manufacturing & packing by QA & production.

Vendor of EHG capsule.

Equipment logbook of capsule filling machine for breakdown.

Training of the visual checkers.

Physical inspection of complaint & control sample.

Review of batch manufacturing record for,

o  In process checks by production & QA during manufacturing & packing.

o  Visual inspection record.

Review of trend of processing, in process & FP Parameters and Handling of the bulk product.

Training record of the visual checkers & strip/blisters

Review of system followed to ensure proper segregation product at different stages.

Review of logbooks of machine at every stage to know the previous or next product taken on the same machine & precautions taken to ensure absence of same /similar product in the surrounding area.

Review of other products packed on the same day on the nearby labelling machine or packing line of product under question.

Review of batch manufacturing record for,

o  Machine & line clearance record at different stages.

o  Reconciliation of packaging materials.

o  Reconciliation of bulk & FP.

Analysis of control &/or complaint sample for,

o  Identification test of two products under question.

o  Identification test of preservative.

Wrong labelling/ packing.

Training record of checker and packers.

Physical inspection of control & / or complaint sample.

Vendor of packing (cap) material.

Compatibility study

Review of stability data.

Comparison of complaint sample with control sample of appearance of strip/ label (font size of letters, printed text matter, size of the pocket, gap between the two pockets, knurling pattern, logo of the company, movement of tab or cap in the pocket etc).

Comparison of complaint sample with control sample of appearance of tablet or capsule (size or dimensions, colour, imprint, embossing, edge type etc).

Analysis of complaint & / or control sample.

Logbooks of striping or blistering machine for breakdown.

Working of Non Fill Detector (NFD) or Blister Inspection system (BIS)

Review of batch document for,

o  In process checks by production & QA during filling.

o  Leak test record.

o  Visual inspection record.

o  In process checks by production & QA during packing (e.g. on line compressed air flow or any other system followed to remove empty plastic container or empty pocket in strip or blister).

o  Yield & reconciliation of the batch & comparison with trend.

Balance or check weigher performance & calibration check record.

Weight variation record of packed cartons &/or shippers.

Proper segregation of packed & empty boxes.

Training record of the visual inspectors.

Physical inspection of control sample.

Previous & next product packed on the same machine.

Appearance of packing material of two products under question.

Review of batch document for,

o  Line clearance (by packing & QA) record.

o  Reconciliation of packing material.

o  Machine & line clearance record.

o  In process checks by packing & QA.

Storage of packing material in the store & in pkg. Dept.

Procedure to be followed for the left over pkg. Material after completion of packing.

Inspection of remaining stock of PM of the products under question.

Training of checker and packers.

Critical Complaint:

A complaint that strongly indicates the purity, identity, safety or efficacy of a product may have been compromised and has the potential to cause a life threatening or serious health situation.

Major Complaint:

A complaint that indicates the purity, identity, safety or efficacy of a product may have been compromised, but does not present as a life threatening or serious health risk.

Minor Complaint:

A complaint that is neither critical nor serious

If complaint is categorized as critical, Head-QA shall intimate (within 24 hours from the receipt of the complaint) to Head – Marketing/Distribution for the immediately stoppage of the further sale and distribution of the batch till the completion of investigation

Head-CQA / QA shall communicate to FDA / Regulatory Affairs / Customer / MA holder / QP / Customer regarding market complaint based on nature of market complaint

The investigation shall be carried out by a team of representatives from QC, QA, Production, Engineering, R&D, FRD, Marketing, RA and etc. (as per nature of complaint).

The investigation shall involve, but not restricted to, examining reserve samples, complaint samples and other samples, review of batches of complaint product, review of batch documents and other related logbooks and documents etc.

If complaint sample is received along with the market complaint, it should be thoroughly examined for the integrity of the pack, physical appearance and evidence of deterioration if any. Complaint sample needs to be checked for detection of counterfeiting. Check for counterfeit sample shall be carried out in accordance with title outline in this SOP as “Handling of Counterfeit Samples”.

In case of quality testing related complaint, QA shall send the complaint sample (if available) or  reserve sample of the complaint batch to quality control department for analysis.

Depending on the nature of complaint, the reserve sample and complaint sample is to be analyzed for the relevant test parameters specified by Head-QA. Analysis of the sample is to be carried out as per  the specification by which the product was registered.

After completion of analysis, QC shall send the analytical report to QA for further investigation.

The Head-QA/Designee shall review the analytical report for compliance to specification that may be relevant to the complaint.

If the results of reserve samples and complaint samples  are complying with the specification or either of samples complying with specification, probable root cause shall be identified with the help of guideline.

Complaint samples received shall be destroyed during of closure of complaint.

 Head – QA shall decide for the extension of the investigation if similar complaints for the product or other products have been received.

 Head – QA shall form an Investigation team, comprising of technical persons from requisite  departments such as QA, QC, Production, Stores, Engineering, R&D, FRD, RA and Marketing depending upon the nature of complaint.

 Investigation team shall investigate the complaint to identify the root cause and to take necessary CAPA.

 For investigation methodology/tools “Failure Investigation and Root Cause Analysis” and for CAPA “Corrective and Preventive Action” SOP can be followed.

The complaint investigation may include the concerned Analytical Report, Batch Manufacturing Record, Batch Packing Record, instruments/equipment’s logbooks, Training  Records,  Stability Records, Cleaning Records, Calibration records, Environmental Monitoring Records of various stages of processing, Storage, Dispatch and distribution of the batch and other related documents such as any deviation in concerned batch.

Previous and next batches of the product shall also be investigated in case of same raw materials / packing materials are used for the batch.

The investigation shall extend to other batches of the same drug product and other drug products if investigation shows the possibility of similar defects in other batches/products.

If required, observations of stability study samples and review of data to be carried out.

If required, help of R&D – Formulations shall be taken in case of process related problems.

Take Medical department opinion (if any) from medical experts as a part of investigation for clinical related complaint.

Investigation team shall identify the root cause of complaint based on the observations made during investigation.

Manager-QA shall summaries the findings in the “Market Complaint Investigation Form” and the same shall be forwarded to Head-QA for impact assessment as per root cause identified.

Head-Manufacturing shall review and recommend suggested corrective and preventive actions.

Finally Head-QA shall review and approve the investigation report and CAPA. In case  the  investigation reveals nature of complaint as Critical, Head-QA shall initiate recall of the complaint batches which exist in the market as per “Product Recall” SOP.

 Head-QA/Designee shall send the investigation report to all concerned persons with the corrective and preventive actions in detail along with target completion date of actions.

TIME LINES FOR INVESTIGATION:

Investigation shall be completed within 7 working days for critical complaint and 30 working days for Major/Minor (or as per Technical Agreement requirement or Regulatory Agency requirement where appropriate) and same shall be sent to marketing department immediately after investigation.

If the complaint is from regulatory agency / MA holder, investigation shall be completed according to their timelines.

Approved Market Complaint Investigation report shall be forwarded to Marketing department, who in turn send response to the complainant.

In case of complaints from export market, QA/RA shall check the regulatory impact. While reviewing the impact, QA/RA shall consider the specific requirements mentioned in Technical Agreement  as   well as country specific requirements.

Wherever applicable, the regulatory agency / MA Holder / QP shall be informed if action is being considered following possible faulty manufacturing, product deterioration, detection of counterfeiting, or any other serious quality problems with a product that could result in a recall  or  abnormal  restriction on supply.

The corrective and preventive actions for all the complaints shall be tracked as per the SOP “Corrective and Preventive actions”.

The acknowledgement from the complainant for the receipt of the response shall be obtained against  the “Letter of Acknowledgment”. If complainant provides acknowledgment through email / letter / fax, same shall be documented.

The complaint shall be treated as “Closed” after receiving feedback from the MAH/Customer/Complainant. The time period for receiving feedback from the customer is 30 days.

If no further query is received within the stipulated time, the complaint shall be treated as closed. The closure details shall be recorded in “Market Complaint Closure Form”.

Designated QA person shall ensure that all correspondence related to complaint is available at site before closure of complaint. Correspondence if made by the Marketing department/ Medical department shall also be requested from the respective department.

In case of receipt of any complaints through a legal route, the investigation findings shall be communicated by Medley legal department in consultation with Head – Quality / QA. A copy of the response shall be kept with the complaint record at QA.

Handling of Counterfeit Samples:

In case if the received complaint samples is suspected to be counterfeit, then it shall be examined as follows:

à  In Comparison of packaging / labeling of the complaint sample with reserve sample.

à  Check the coding style / printing of the batch details.

à  Quality of the packaging components.

à  Organoleptic properties of the drug in comparison with reserve sample.

If the comparison of the packaging components, coding style and organoleptic examination does not reveal the conclusive evidence then perform the analysis of the complaint sample along with reserve samples.

During the course of investigation, if the complaint sample received found to be counterfeit then Head-QA shall inform to marketing and Medley representative in countries where the company’s products are marketed for appropriate action through Head-CQA.

In case of counterfeit complaint, put relevant remark in “Market Complaint Log” and in “Market Complaint Investigation Form” and close the complaint.

REVIEW AND TRENDING OF COMPLAINTS:

Head – QA shall review the complaint status every quarter to evaluate specific or recurring problems which require further attention.

Designated QA person shall prepare complaint yearly trends. Trends shall be reviewed by Head- QA and required action shall be taken accordingly.

The records of all  market complaints for drug products and the follow-up / related  records shall  be kept for one year from the date of expiry of the batch for  which  the  complaint  has  been received.