SOP for Handling of Market Complaint

This Document describes (Standard Operating procedure) SOP for Handling of Market Complaint.

SOP for Handling of Market Complaint

I. Purpose & Scope:

• The purpose of this SOP for Handling of Market Complaint.
• This Standard operating procedure shall be applicable for Handling of Market Complaint.

II. Responsibilities:

• All Quality Assurance personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part:

1) Procedure :

• All oral or written communication received from a complainant (Regulatory Authority, Distributors / Retailers / Stockiest / Field Staff / Customers / Doctors) regarding the defects in the product quality shall be considered as Market Complaint.
• Head/Designee-Quality Assurance shall review the complaint for its originality and declare as ‘Justified’ / ‘Non-Justified’
• The product complaints shall be categorized as follows:

2) Critical complaint :

Those defects in which there is a reasonable probability that the use of, or exposure to, is life threatening or could cause serious risk to health or death and require the company to make immediate action by all reasonable means. Such as,

• Complaints of product mix up/Mislabeling
• Adverse drug reactions, if drug declared as spurious drug that has caused or has been found to have potentials to cause serious health hazards
• If the drug found to produce pharmacological reaction other than it purports to do.

3) Major Complaints :

Those defects in which the use of, or exposure to, could cause illness or mistreatment may put the patient at some risk but are not life threatening. Such as

• Complaints of missing of batch overprinting details on Product,
• Failure of product to comply with the finished product specifications
• Any labeling misinformation (or lack of information) which represents a significant hazard

4) Minor Complaints :

This category covers the complaints about the defects that can be noted and corrected by a scheduled program. Such as,

• Complaints of de-shaped or
• Defaced secondary packaging components,
• Shortage such as empty pockets, missing blister, missing leaflet.
• The site QA shall log in the complaints in the register with specific identification number (ID no)  and other relevant details.
• Complaint Identification Number shall be allotted in the Following number :
• CP/XX/YYY

Where,

CP – Indicate complaint

XX – Last Two Digits of Current Year.

XXX – Serial Number Starting from 001, 002, 003…..

For e.g.: CP/19/001 is the fifth complaint in the Year 2019.

• The complaint serial number shall run in serial order and enter in Market complaint register with following details:
• Complaint No. and Name of product
• Batch No., Mfg Date / Exp. Date
• Complainant Nature and Type of complaint
• Complaint closed on

5) Market Complaint time frame details:

Details	Critical	Major	Minor
Log- in time	Same day after receipt of complaint (Working day)
Acknowledgement of complaint	Within 24 hrs (Working day) from date of receipt	Within 2 days (Working day) from date of receipt	Within 2 days (Working day) from date of receipt
Intimation to concern Regulatory authority/ MA Holder /EUQP/ PL Holder / CG (as applicable).	Within 48 hours from acknowledgement of complaint.	Within 3 working days from acknowledgement of complaint.	–
Investigation report	Within 5 working days Preliminary /interim investigation report and Further Investigation report within 15 working days from date of receipt.	Within 30 working days from date of receipt	Within 30 working days from date of receipt
Timeline for closure	Within 30 working days from the date of reply	within 45  working days from the date of reply	within 45working days from the date of reply

 

6) Investigation of Market complaint :

• All market complaints oral or written shall be channeled through the Quality Assurance.
• All verbal communication to be noted and records to be kept along with investigation report.
• Head – Quality Assurance/designee and other functional head/designee shall be responsible for the investigation of Market complaint.
• However in case of critical complaints about Adverse Drug Reaction or in event of potential hazard or risk to the patient, which calls for immediate action / Product Recall, the Initiator shall directly inform the management.
• Head – Quality Assurance/Designee shall further investigate this based on the nature of complaint. If no samples have been received, if required they shall be requested.
• If any market complaint on investigation is believed to have an impact on the quality, safety or efficacy of other products, action shall be initiated on the other products If required the contract giver shall also be informed immediately about the course of action.

7) The investigation may include (if require), but not limited to the following as applicable:

• Review received complaint sample/photograph or other information etc
• Compliant sample analysis/retained sample analysis
• Verification of counterfeit /suspected compliant sample
• Review of Analytical Reports for incoming materials and finished product for compliant batch and same nature complaint.
• Review of Batch records and analytical data of batches manufactured in the same period.
• Physical and analytical verification of the controlled samples of complaint batch and previous three batches and subsequent three batches.
• Verification of stability samples.
• Verification of quarantine stock for compliant batch or same nature batch.
• Review of formulation/Product packaging configuration
• On the basis of the complaint nature, impact analysis shall be done for the preceding and succeeding batches of the same product and other product.
• Checking the training records of the concerned responsible person and to identify the need for retraining.
• Review of trend data of Annual Product Review records.
• Review of the stability data.
• Review of preventive maintenance
• Manufacturing and packaging operation walk through for key process
• Review of validation and qualification
• Review of past same nature complaint
• Review of dispatch details
• Any other focused area
• The records, Investigation details and findings of the complaints shall be recorded in detail investigation report.
• Complaints received from drug regulatory authorities may be attended and evaluated as per the directives received from them.
• 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.
• The Implemented corrective and preventive action plans should be periodically checked through internal audits or need based.
• The Head QA/designee shall prepare summary of investigation report and send the final reply to the Functional Head (concerned Marketing Division)/Regulatory head.
• The marketing head / coordinator/ Regulatory head shall be responsible for correspondence with customers / agencies for all complaints. The same shall be communicated within one working day by email / fax/ courier.
• In case of result of an investigation of a complaint of one customer the root cause shows that the same material was also used for other customer, then the other customer shall be also be informed about the nature of complaint and the corrective measure implemented. This shall be communicated by the marketing head / coordinator within one working day by email / fax / courier.
• In case of any quality complaint or enquiry regarding the product manufactured for export to any country is received from regulatory body then; marketing head shall immediately inform customers / agencies and inform about the course of action and seek their advice on further proceedings if required.
• Market complaints should be referred to Formulation and Development Head where the nature of complaint is (e.g. quality of the product, broken product, dissolution of product etc.) required.
• The Adverse Drug Effects associated with Technical Complaints should always be referred to Medical officer, Regulatory Head, Head F&D by site QA Head.
• Normally each product complaint shall be replied within 30 working days / 45 working days or as per classification from the date of receipt.
• The market complaint shall be treated closed if no further query has been raised by the complainant within 45 working days from the date of reply. The complaint will be closed with necessary remarks on it and all the complaints should be archived at one place.
• If query has been raised by the complainant after 45 working date from the date of reply same complaint shall be re-open.
• At the end of year, a data for all the product complaints received in the year shall be recorded and Trend analysis to be performed .
• All the corrective action / preventive actions suggested by company and or agreed upon by the customers / agencies shall be implemented and the action and subsequent verification for their effectiveness shall also be immediately communicated to the customers / agencies once established.
• The corrective action based on findings of complaint may result in product recall, Field alert report to FDA which is to be decided by management. Follow the procedure for product recall follow the procedure as per SOP.

IV) ANNEXURE:

Annexure No.	Name of format
Annexure – I	Market Complaint Investigation Form
Annexure – II	Complaint register
Annexure-III	Market Complaint Trend

 Annexure I 

Market Complaint investigation form

Complaint Report Number details:

Complaint No

:

Received on

:

 

• Product Complaint Report received details :

Customer’s Name	Country	Received via	Dispatched qty

 

• Product Details:

Product Name	Batch No.	Mfg. Date/ EXP Date	Pack size

 

• Originality of Complaint:

 

Justified	Non Justified

 

 

• Nature Of Complaint:

 

• Compliant sample receipt details:

Product Name
Batch No.
MFG Date/EXP Date
No. of sample received
Received on and received through

 

 Type of Complaint: Quality (Critical/Major/Minor)/Adverse effect/event

 

• Investigation:

• Past history (Details of earlier complaint of similar nature if any) :

Past History details	Yes/No
For same product
For Same Nature
If yeas give the details for the same:

 

• Root Cause

 

• Corrective Action and Preventive Action:

 

• Conclusion:

• Batch withdraw status:

Compliant nature (Critical/Non-Critical	Batch withdrawal from market require (Require/Not Require)

 

• Investigation Team:

Name	Designation	Sign and Date

 

• Investigation Approval:

Name	Designation	Sign and Date

 

• Complaint Close Out Details:

Closed by (QA) (Sign and Date)		Approved by (QA head/Designee) (Sign and Date)

 

Annexure – II

Complaint register

Sr. No.	Complaint No	Name of Products	Batch No	Mfg. Date  / Exp. Date	Complaint  nature	Type of Complaint	Complaint Closed on

 

Annexure-III

Market Complaint Trend analysis

Review Period: From__________ to _____________       Details of Received Market Complaints:
Nature of Complaints	Total Number	Classification			Open			Closed			CAPA implementation Pending
		Critical	Major	Minor	Critical	Major	Minor	Critical	Major	Minor
Human error
Machine related
Process related
Material related
Prepared By:                                                                         Reviewed By:                                                                          Approved By: (Sign. & Date)                                                                      (Sign. & Date)                                                                         (Sign. & Date)