1. Objective:

To lay down the procedure for handling of Market Complaints related to Intermediates &/or API.

2. Scope:

Applicable to all market complaints related to API &/or Intermediates.

3. Responsibility:

Marketing Dept., QA, QC, Regulatory Affairs, Quality Head, Site Head

4. Definitions:

  • Market Complaint: Complaint simply designates the something is wrong or not good enough. Market complaint in pharmaceutical industry indicates the customer dissatisfaction regarding quality of product, received verbally or in written format.

5. Procedure:

Basically, there are three types of complaints:

  • Quality related: Originating at consumer level & concerned with physical, chemical & biological properties or condition of labeling &/or packaging of the product.
  • Adverse Reaction related: Due to allergic reactions of any other untoward reaction or fatal reaction or near to fatal reaction
  • Other Medical Complaints: Such as lack of efficiency or clinical response.

Further on basis of Criticality, complaints can be categorized as

  • Critical Complaints: These can be Life threatening & require company to take immediate action. Such as Cross contamination of product, serious adverse drug reaction etc.
  •  Major Complaints: They can put patient health at some risk & requires product recall or withdrawal from market within a few days like loss of potency, significant discoloration etc.
  • Minor Complaints: Related to defect in product quality, packing defects which lead to least problem to patient’s health

Complaints can be received written or by verbal communication by customer, retailer, wholesaler, doctors, etc.

On receipt of the market complaint, QA shall log the complaint in Market Complaint Log with details like product name, complaint type, complainant name & date of receipt.

QA shall assign the identification no. to Market Complaint as follows:

MC-XXX-YY

Where MC stands for Market Complaint

 XXX stands for sequential no. starting from 001, 002 & so on & starts form January 1

           YY stands for last two digits of current year (for ex. 19 for 2019)

  • Review, Investigation, Evaluation & Closing of Complaints

Review:

  • QA head shall review the complaints & evaluate whether investigation is required or not.
  • If required, then QA head shall investigate complaints along with HODs of other Depts.


Preliminary Investigation Report:

  • QA shall start preliminary investigation prepare report within 7 working daysfrom receipt of complaint.
  • The conversation documents shall be chronologically attached with the market complaint investigation report.
  • Preliminary Investigation Report shall contain following information but not limited to,

-Complaint received from

-Product Name & batch no.

-Complaint Details

-Type of Compliant

-Investigation

-Conclusion /Root Cause

-Corrective And Preventive Action taken / proposed

-Request to Complainer/Customer like any sample, document, procedure required from customer for the investigation

  • The Preliminary Investigation report shall be Signed & approved by Quality Head & Site Head & shall be forwarded to the Customer via marketing.
  • If the root cause is identified in the preliminary investigation report and the CAPA is satisfactorily addressed then there shall be no need for Final Investigation.
  • In case investigation represents that complaint is serious & affect quality, safety, efficacy of product then detailed investigation shall be carried out.

Detailed Investigation report:

  • QA shall continue further investigation and complete the investigation within 30 working days from the date of receipt of compliant
  • In case extension is required then interim report must be prepared as on 30 days status report and take due authorization /approval from Quality head & Site head.
  • Brief flow, of investigation, but not limited to, is narrated as under.

-History (whether such incidents happened in past).

-Manufacturing documents (i.e. BMR, ECR).

-Change control register, event register, incident register, OOS register, forced degradation data and stability data.

-Cleaning/sanitization/sterilization/depyrogenation records.

-Training documents of concerned persons.

-Qualification /calibration records of equipment / machines.

-Environment monitoring records.

-Sequential logs of equipment / machines.

-Age of the equipment. Type of reaction or operation being done.

-Preventive / breakdown maintenance records of equipment/machines to identify wear and tear.

-Standard operating procedure.

-Specification / test procedures /sampling procedure review and Comparison with customer specification.

-Stability data/ data of additional testing/data of trials.

-Trend of process / quality parameters of the product/ equipment/ material used. (Comparison of incident batch with other batches).

-The investigation report shall also address additional testing / generation of trial data, as appropriate.

-Analysis of control sample/Complaint Sample of the batch or the batches manufactured within the specified time frame or batches available in ware house.

-Check distribution records to identify the customers, in case if notification is required to be sent and availability of material in ware house.

-Analysis and discussion of joint analysis

-Investigations done if any with the involvement of R&D.

  • Root cause (Probable/assignable) /Conclusion: A clear description of assignable or probable root cause of the complaint must be recorded based on investigation. In case there is no Root cause (Probable/assignable) identified mention the brief conclusion.
  • Corrective action taken / proposed: The term “correction” usually refers to the repair, rework or adjustment made to the product as part of the disposition of an existing nonconformity. Include the actions taken / proposed to correct machine / system / batch.
  • Preventive actions taken /proposed: A preventive action is an action taken to eliminate the cause of a potential non-conformity, defect or other undesirable situation in order to prevent its occurrence. Include preventive actions if any.
  • Request to Complainer/Customer: If any requirement / information required from the customer or recommendation to the customer shall be mentioned in the section.
  • After completion of investigation, conclusion shall be made by Head QA & closing comments shall be mentioned.
  • Any concluded/signed investigation report is liable to be supplemented if the customer or Regulatory Agencies or Quality system auditing agency suggests to investigate further.
  •  The supplement investigation report shall be clearly identified as “supplementary investigation report” and shallbe supplemented with previously concluded/signed investigation report.   Such   supplement investigation report shall be shared to the customers to whom the investigation reports were submitted.

Complaint Closure:

  • The market complaint closure shall be done as per the given format.
  • If complaint is substantiated then verify the distribution record to identify the customers to whom the defective product batch have been distributed and initiate recall of the product, if required.
  • During investigation, if critical defect is identified, product recall shall be carried out.
  • Marketing department shall get a written acknowledgment for either acceptance or rejection of the investigation report from the customer and shall forward the same to the QA.
  • Complaint shall be considered “closed” in case if customer fails to communicate acceptance/non-acceptance of the investigation report and the material within 30 working days. The same shall be recorded in the closure part of the market complaint Investigation report.
  • Impact analysis: Include the impact on quality of the product batch/es manufactured prior to or after the manufacturing date of the questioned batch.
  • Also evaluate the impact on quality of the distributed or ready for distribution product batches.
  • In case if the failure is confirmed upon analysis, investigate the failure and extrapolate to the other product batches analyzed by initial chemist till date and document in the investigation report.
  • Repetitive complaint: Identify from Market Complaint Log and record if same type of complaint is received from other customers. Check and verify distribution record to identify the customers to whom the complained batch is distributed and notify to those customers through Marketing for recall, if the complaint is substantiated or confirmed.
  • After verifying all relevant investigation, CAPA and documents the market complaint shall be closed and will be informed to CQ. All documents shall be attached chronologically with the market complaint investigation report.
  • All market complaints shall be reviewed quarterly & trends shall be prepared.

Closure of Market Complaint

Impact Analysis:

1 Recall Required / Not Required (If required Recall No)  
2 Impact on the other batches of the product and on other product. :  
3 Information to third Party :  
4 Any other  
5 Material accepted by Customer
If NO and material returned, Handle the material as per the Return Goods Procedure  
YES / NO
6 Sales Return No. :  
7 CAPA No. :      
8 Market complaint Closed by (QA) / Date :