| STANDARD OPERATING PROCEDURE | ||
| Title | : | Procedure For Handling of Market Complaints |
OBJECTIVE
To lay down the Procedure for Handling of Market Complaints.
SCOPE
This Procedure is applicable for handling of market complaints received from wholesaler, Distributor, Retailer, Customer, Physicians, Patients, field staff etc. at Pharmaceutical Company.
RESPONSIBILITY
It is a joint responsibility of Manager-Marketing and Manager-Quality Assurance in coordination with Quality Assurance.
It is a joint responsibility of Country Manager/Company appointed Business agent in coordination with Quality Assurance (In-case of Export).
Executive – Quality Assurance.
ACCOUNTABILITY
Manager – Quality Assurance.
PROCEDURE
RECEIPT OF PRODUCT COMPLAINT
COMPLAINT MAY BE RECEIVED FROM
Wholesaler
Distributor
Retailer
Customer
Physicians
Patients
Regulatory agencies/National Health Authorities
COMPLAINTS MAY BE GENERALLY RECEIVED BY FIELD STAFF
Medical representative
Manager – Marketing
Company appointed Business agent (In-case of export).
- Complaint may be in written or verbal. In-case of telephonic message, the receiver shall try to get the detailed information so as to facilitate the investigation.
- Manager- Marketing / Company Appointed Business agent shall take all the efforts to get a complaint sample (if applicable).
- Manager- Marketing / Company Appointed Business agent shall send a copy of correspondence received from the complainant along with the complaint sample to Site, Manager – Quality Assurance.
- All such complaints shall be addressed to the Manager-Quality Assurance.
- On receipt of the complaint the following additional information shall be obtained.
- Defected Product Name, Batch No(s).
- Nature of defect & details.
- Any adverse health problem occurred from the use.
- Name and complete address of the complainant.
- Stock details of the particular batch (s) in distribution chain.
- Specimen sample of defect sample.
- On receipt of the above information Manager-Marketing and Country Manager/Company appointed Business agent (In-case of export) shall forward the details to Site Quality Assurance along with the specimen sample of the defect product and a copy of correspondence received from the complainant.
HANDLING OF PRODUCT COMPLAINT.
On receipt of product complaint, Quality Assurance shall enter the details in the Market Complaint Register.
QA shall assign a unique, sequential number for each quality complaint as below
XX / XXX / XXX-XX
Last Three Digits of Sr. No. Running Calendar Year
Next Three Digits of Sr. No.
Initiator Department Code
Company Code
FOLLOWING INFORMATION SHALL BE ENTERED INTO THE MARKET COMPLAINT REGISTER.
- No.
- Date
- Complaint No.
- Name, Address and Telephone Number of the Complainant.
- Product Brand Name/Generic Name.
- Batch No.
- Date of Mfg/Exp date.
- Details and nature of the complaint.
- Investigation details.
- Investigation Report send to Marketing / Country Manager.
- Done by
- Verified by
- Remarks
- In-case the complaint relates to an adverse effect on health or might produce an adverse effect on health, pass the information immediately to G.M. Technical and action shall be initiated within 24-48hrs.
- In such case initiate recall committee meeting and proceed as per SOP Procedure for product recall.
- On receipt of product complaint (In case of export), Company Appointed business agent will inform the National health authority/competent authority of the country on the nature of complaint to the competent authority of the country. Further the company appointed business agent will be continually updating the further proceedings of the complaint like impact of complaint, critical findings of investigation, possible effected batch(s) adverse effect on health, etc. to the National Health Authority/Competent Authority of the Country.
- In case complaint is regarding the product quality and efficacy, Head Quality Assurance shall carry out detailed investigation, check the control samples of the same batch and analyze the same. Necessary help from QC may be taken, in case if stability is under question.
- Investigation shall be extended to other batches, which may be affected by the reason of complainant.
- Batch Production and control Record and related documents shall be checked thoroughly by Manager – Quality Assurance and Manager-Production to check for any deviations or abnormalities reported or recorded during the manufacturing of the subjected batch.
- Manager-Quality Assurance along with the assistance of the Manager –Quality Control and Manager-Production shall conduct a detailed investigation of the defect and cause of the complaint.
INVESTIGATION SHOULD CONSIST OF THE FOLLOWING
-
- Inspection of the defect product.
- Analysis of the defect product, if required.
- Examination of the control sample.
- Review of the analytical report and related document.
- Review of the Batch Manufacturing and Packing Records.
- Review of the other related documents.
- The findings of investigation shall be assessed by Manager –Quality Control & Manager-Production.
- Finally Manager-Quality Assurance shall evaluate the investigation findings and propose corrective action to avoid the re-occurrence of the complained defect.
- Document the investigation findings .
- 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.
- After the investigation, appropriate follow-up action shall be initiated including product recall if necessary based on the evaluation of the complaint by Head medical.
- The corrective action plan and measures taken as a result of complaints shall be recorded and referenced to the corresponding batch records.
- Review the complaint records annually for any indication of specific or recurrent problems that require attention and might justify the recall of marketed products.
- Copy of investigation report shall be sent to Manager-Marketing & Company appointed Business agent (In-case of export) to give feed back to the complainant.
- Send a copy of investigation report to the competent authority of the country (When exported), together with all related information on the corrective action followed, and affected related batches distributed to the country and action plan taken for future.
- Based on the investigation conclusion instruct the distribution in-charge to initiate hold of further distribution of the said batch(s) or to recall the said batch(s) from the distribution chain and arrange for free replacement.
- All the documents related to the market complaints shall be retained at least one year beyond the expiration date of the product or one year after the, date of receipt of the complaint whichever is longer.
- Closing time required for domestic market complaints is one month and for export market complaints, it is three months.
ABBREVIATIONS
SOP – Standard Operating Procedure
QA – Quality Assurance
ATTACHMENTS
| Sr. No. | Title | Format No. |
| 7.1 | Product Complaint Form | |
| 7.2 | Market Complaint Investigation form | |
| 7.3 | Market Complaint Register |
DISTRIBUTION LIST
| Sr. No. | Copy No. | Department |
| Quality Assurance | ||
| Quality Control | ||
| Quality Control – Microbiology | ||
| Production | ||
| Engineering & Utility | ||
| Personnel & Administration | ||
| Warehouse |
ATTACHMENT-I
PRODUCT COMPLAINT FORM
Complaint No.: …………………….
Date: ..……………………..
To,
Manager – Quality Assurance
1.0 Product : …………………………………………………………..
2.0 Batch No. : …………………………………………………………..
3.0 Date of Mfg. : …………………………………………………………..
4.0 Date of Exp. : …………………………………………………………..
5.0 Complaint received from
Party Retailer Physician Patient Others
Regulatory agency/National Health authority /competent authority of Country
Address and phone number of the complainer.
……………………………………………………………………………………………………
……………………………………………………………………………………………………
6.0 Defected sample enclosed Yes ( ) No ( )
Nature of complaint
……………………………………………………………………………………………………
7.0 Defect related to adverse health problem Yes ( ) No ( )
Details:
……………………………………………………………………………………………………
8.0 Complaint received by:
Sign & Date ______________________
(Marketing Department)
- Defected sample received by
Sign & Date ______________________
(Marketing-Department)
10.0 Product complaint forwarded by
Sign ______________________
Date______________________
(Manager-Marketing)
ATTACHMENT-II
MARKET COMPLAINT INVESTIGATION FORM
Complaint No. : ………………………………………………….
Complaint received on : ………………………………………………….
- Defect sample inspection
| OK | Not OK | Remarks | ||
| a) | Physical Appearance | |||
| b) | Packaging Components | |||
| c) | Printed Matter | |||
| d) | Other if any (specify) |
2.0 Control Sample Evaluation:
| OK | Not OK | Remarks | ||
| a) | Physical appearance | |||
| b) | Packaging Components | |||
| c) | Printed Matter | |||
| d) | Other if any (specify) |
3.0 Analytical Evaluation:
(Q.C. Reports to be attached)
| OK | Not OK | Remarks | ||
| a) | Specimen Sample (Defected Product) | |||
| b) | Control Sample | |||
| c) | Review of analytical reports | |||
| d) | Other related documents (Specify) |
4.0 Batch document evaluation:
| OK | Not OK | Remarks | ||
| a) | Review of BMR/BPR | |||
| b) | Other related documents (Specify) |
5.0 Product Details
- Product on which complaint received :
……………………………………………………………………………………………
- Other related B. No, investigated
……………………………………………………………………………………………
6.0 Assessment of Complaint
6.1 Review comments from Manager-Quality Control:
……………………………………………………………………………………………
Sign/Date: …………………………………………….
(Manager-Quality Control)
6.2 Review comments from Manager- Production:
……………………………………………………………………………………………
Sign/Date: ………………………………………
(Manager-Production)
7.0 Recommendations from Manager-Packing:
……………………………………………………………………………………………
Sign/Date: ……………………………………….
(Manager-Packing)
- Comment on adverse effect on health (If applicable)
……………………………………………………………………………………………
Sign/Date: ………………………………………
(Head-Medical Officer)
- QA Evaluation of complaint :
……………………………………………………………………………………………
- Details of Destruction (if Applicable):
| Batch No | Quantity | Quantity received from recalled/in stock/ Other than factory | Mode of destruction |
11.0 Action plan for the said batch(s):
11.1 To recall from market
11.2 To hold further distribution
11.3 To replace quantity
11.4 Others
Specify: ……………………………………………………………………………………………
12.0 Proposed Corrective Action for future:
……………………………………………………………………………………………
13.0 Conclusion Report:
……………………………………………………………………………………………
Sign with Date: ………………………….
(Manager – Quality Assurance)
ATTACHMENT-III
MARKET COMPLAINT LOG
| Sr. No. | Date | Complaint No. | Name, Address & Telephone No. | Product Name | Batch No. | Mfg./Exp. Date | Details & Nature of Complaint | Investigation
Details |
Investigation report send to marketing on | Done by | Verified by | Remarks |
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