handling and investigation of Market Complaints

OBJECTIVE :
1.1 To lay down a procedure for handling and investigation of Market Complaints.
2.0 SCOPE :
2.1 This procedure is applicable to all written or oral market complaints (regarding finished product manufactured at ABC Pharma Private Limited) received either from customers, regulatory authorities or distribution points.
3.0 RESPONSIBILITY :
3.1 QA Executive / Sr. Executive:
3.1.1 Logging of Complaint received from Customer or Other department.
3.1.2 Assigning a number to the Complaint.
3.1.3 Distribution to concerned departments. (Production / QC/ Warehouse)
3.1.4 Maintaining records.
3.1.5 Preparation of an investigation report.
3.1.6 Response to the customer based on the Market Complaint investigation report.

3.2 Manager Production:
3.2.1 Investigation of Complaint / Preparation of Investigation report.

3.3 Head Quality control(QC):
3.3.1 Analysis of the Complaint sample and / control sample as applicable.

3.4 Head Quality Assurance:
3.4.1 Investigation of Complaint.
3.4.2 Classifying the market complaint and initiate investigation.
3.4.3 Coordinating with relevant Head of Department for gathering the information.
3.4.4 Preparation of investigation report.
3.4.5 Ensuring the timely implementation of any corrective and preventive action.
3.4.6 Responsible for implementation of this SOP.

3.5 Plant Head/Director shall be responsible for:
3.5.1 Monitoring the market complaint handling.

4.0 ACCOUNTABILITY :
4.1 QA Head / Plant Head

5.0 PROCEDURE :
5.1 Receipt of the Product complaint:
5.1.1 Any verbal or written communication received directly from any customer, retailer, distributor, physician pharmacist, patient (Consumer) , regarding the Identity, purity, efficacy, side effect, labeling / packaging defects, shortages or any other such Complaints shall be considered as a Market Complaints.
5.1.2 Complaints received from anywhere shall be registered with the QA Department as refer Annexure-1.
5.1.3 QA shall enter source from where complaint received & date of complaint received refer Annexure-1.
5.1.4 QA shall enter the Complaint in the Market Complaint register as per the Annexure-2.
5.1.5 On receipt of the complaint the following additional information shall be obtained.
5.1.6 Defective product name, Batch No(s), Manufacturing and Expiry Date, reference sample of defective product.
5.1.7 Nature of defect in detail.
5.1.8 No. of pack/container involved
5.1.9 Container sample enclosed or not
5.1.10 Name and complete address of the complainant including the email id and contact no.
5.1.11 Brief Description of Complaint.
5.1.12 Nature of Complaint like; Product defect, packaging defect, Adverse drug reaction, other-specify

5.1.2 Logging of the Complaint in the register shall be done as MC/YY/ ZZZ.
Where, MC- stands for market Complaint
YY- represents the year in which the Market Complaint is received.
ZZZ- represents the serial no. of Market Complaint starting from 001,
002…so on of each Year in which the Market Complaint is received.
Example: MC/19/001 represents the first Market Complaint in the year 2019.
5.2 Type of Complaint:
5.2.1 Critical: The defect presents a life threatening or serious risk to health.
5.2.1.1 Wrong product (label or packaging relevant to a different product)
5.2.1.2 Correct product but incorrect dosage/strength with serious consequences for health.
Microbial contamination of injectable products.
5.2.1.3 Chemical contamination with serious consequences for health.
5.2.1.4 Mix up of product with more than one container involved.
5.2.1.5 Adverse Drug Reaction.

5.2.2 Major: The defect may cause mistreatment or harm to the patient but is not life threatening or serious
5.2.2.1 Microbial contamination of injectable products.
5.2.2.2 Major chemical / physical contamination.
5.2.2.3 Primary container that is not intact (defect not obvious).
5.2.2.4 Missing or incorrect information on the leaflet /package.
5.2.2.5 Mix up.

5.2.3 Minor: The defect is unlikely to cause harm to the patient.
5.2.3.1 Primary container that is not intact (defect obvious).
5.2.3.2 Damaged secondary packaging.
5.2.3.3 Poor or missing overprint.
5.2.3.4 Missing components.
5.2.3.5 Quantity error.
5.2.3.6 QA will make an initial assessment and detailed investigation as to whether the Complaint appears justifiable or not and whether the complaint sample received or not.
5.2.3.7 Unjustified Complaints shall be sent back to the customer along with a justification note.
5.2.3.8 Results of Observation and Analytical findings shall be attached with the investigation report in case of any analysis is carried out for Complaint samples, Control samples or related samples.
5.2.3.9 Quality Assurance department shall determine the past history of complaint whether similar nature of complaint occurred earlier or not.
5.2.3.10 If the Complaint is assessed as critical, then Head- Quality Assurance shall instruct the Head-Distribution to immediately stop further distribution / dispatch of the Batch (and any associated batches) until the investigation is over.
5.3 Note:
5.3.1 If there is a report of serious adverse drug reaction resulting from the use of a drug, then the concerned drug licensing authority shall be appropriately kept informed.

5.4 Investigation:
5.4.1 Head Quality Assurance is designated as responsible for handling market complaints and deciding the measures to be taken.
5.4.2 Head Quality Assurance shall record the physical description of the Complaint Sample as per Annexure-1
5.4.3 Head-QA shall investigate first regarding the authenticity of the complaint. If after investigation it is found that it was just the mistake or misconception of the complainer, he shall document the same and close the complaint.
5.4.4 In case, if the complaint is found to be genuine after identification of problem, check if it is for goods shortage or a quality related compliant. In case of the goods shortage investigate the cause, alert the line crew and close the complaint.
5.4.5 If analysis of the complaint sample (if available) or analysis of the reference /control sample is required and approved by the Head- Quality Assurance then Quality Control shall perform the required determination(s).
5.4.6 Then after, Head –QA, Head-QC, and Head Production shall jointly analyze the findings observed during the investigation with maximum possible ways.
5.4.7 QA shall send a copy of the Complaint to customer for their consideration and investigation (if required).
5.4.8 QA shall review the following topics although all may not be mandatory for each complaint:
5.4.8.1 The Batch Record
5.4.8.2 Analytical testing data for the batch.
5.4.8.3 The complaint sample
5.4.8.4 The reference/control sample
5.4.8.5 Any deviations that may have caused the complaint
5.4.8.6 Any other similar complaints received for the same defect (whether or not the same product) received in last two years
5.4.8.7 The environmental monitoring data.
5.4.8.8 The implications to other batches (RM/PM of Lots/AR Nos.)
5.4.8.9 Based on the observations, Head Quality Assurance shall identify the root
Cause of the complaint.
5.4.8.10 Finally Head Quality Assurance shall evaluate the investigation findings and propose corrective action to avoid the recurrence of the complained defect (for CAPA refer SOP-FPPL/QA/015-01)
5.4.9 The findings of investigation shall be assessed by Plant Head/Director and Head QA along with their comments.
5.4.10 Prepare a Market complaint investigation report as per the Annexure-1 and make the entry market complaint register as per the Annexure-2. Document the report if the complaint is still considered justified and if the categorization of Critical, Major or Minor is appropriate.
5.4.11 Based on the investigation findings, if product defect is discovered in a batch, consideration should be given to check other batches in order to determine whether they are also affected. In particular, other batches that may contain reprocess able recovery added from the complained batch of the product shall
be investigated.
5.4.12 If after the findings any change is to be required either in the process or in the Equipment shall be done prior permission to be taken from the Plant Head/Director and to be done according to the process of change control. This whole process shall be documented in the investigation report.
5.4.13 On completion of investigation report, the Head Quality Assurance shall prepare a response to the Complaint based upon the findings of the investigation report and mention the date of Final Report sent to Party in Annexure-1.
5.4.14 After the investigation, appropriate follow-up action shall be initiated including product recall if necessary. Product recall shall be recommended by Head QA .Product recall shall be done as per respective SOP.
5.4.15 Initial response shall be sent to the Party within 3 days after receipt for Critical Complaints, and within 7 days after receipt for non- critical Complaints.
5.4.16 The Complaint shall be treated as “Closed” after receiving satisfactory feedback from the customer or if no response is received in the time period outlined below:

5.5 The time period for receiving feedback from the customer is:
5.5.1 Customer feedback from the Market within 3 weeks.
5.5.2 Head Quality Assurance shall review and close the Market Complaint.
5.5.3 Analyze & review the customer Complaint status every quarter to evaluate specific or recurring problems, which require further attention.
5.5.4 Flow chart for handling of Market Complaint as per Annexure-3.

6.0 ABBREVIATION:

Sr. No.	Abbreviation used	Full form of abbreviation used
1.0	SOP	Standard Operating Procedure
2.0	QA	Quality Assurance department
3.0	QC	Quality Control
4.0	RM	Raw Material
5.0	PM	Packing Material
6.0	CAPA	Corrective Action & Preventive Action
7.0	No.	Number

7.0 ATTACHMENTS (ANNEXES) :
Annex I : Market Complaint Investigation Report
Annex II : Market Complaint Register
Annex III : Flow chart for Handling of Market Complaint

8.0 REFERENCE:

Sr. No.	Reference Title
1.0	Schedule M (Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products) of Drugs and Cosmetics Act-1940, Drugs and Cosmetics Rules-1945, India

Annex I :

Market Complaint Investigation Report