Complete Pharma Solution
SOP on Handling of Market complaints
OBJECTIVE :
To establish a procedure to investigate, document, respond and review of all product-related complaints received
RESPONSIBILITY :
Quality Assurance department to process and respond to all product complaints.
Head – RA to co-ordinate with concerned Regulatory Authority.
Head of Quality Assurance Department to ensure compliance.
PROCEDURE
Every product complaint received shall be appropriately documented and responded to in a responsible manner.
All the departments shall be instructed to forward all written and oral product complaints to the Head of Quality Assurance Department.
Each complaint will be assigned a five-digit complaint number consisting of the last two numbers of the current year, followed by a dash and the next sequential three digit number.
For e.g.., The first complaint received in 2023 will be assigned complaint number 23-001.
Note : If a product complaint is determined to be serious and unexpected as stated in 21 CFR 314.80(c)(1)(i),
The Complaint Information Form (annexure-1) shall be filled in order to document all the available information regarding the complaint by Officer-QA and filed in Complaint File kept in QA Office.
If any complaint sample is received, the same shall be labeled with the complaint number.
A complaint acknowledgment letter shall be sent to the complainant in a timely manner. A copy of the acknowledgment letter will be filed in the complaint file.
If the complaint can be attended within one week, the final response letter can be submitted to the complainant instead of the complaint acknowledgement letter.
All the final responses, shall be sent within 15 days from the date of receipt of complaint or upon full information on the complaint.
Investigation :
Head – Quality Assurance shall arrange for review of Batch Production Record, as necessary.
Head – Quality Assurance shall arrange for examination of Reserve Sample of the complaint batch, as necessary.
An investigation request memo alongwith any available product sample, shall be forwarded to the concerned department by the Head of Quality Assurance department for investigation.
The appropriate department investigating the complaint shall document their findings and conclusions and prepare a report.
In case an investigation is not desired, the reason and name of the responsible person taking this decision shall be stated on the report.
The report alongwith any remaining complaint sample, shall be forwarded to the Quality Assurance department.
Officer – QA shall ensure storage of remaining complaint sample in reserve sample room.
Depending upon the nature of the complaint, extend the investigation to other related batches also.
Once the investigation is complete, Head of Quality Assurance department shall review the report and correlate with trend analysis data available for the concerned product as per SOP “Annual Review of Drug Product Quality”.
Head of Quality Assurance department shall prepare the final response letter to the complainant or the appropriate agency. A copy of the same shall be distributed to Divisional Head and Head of RA department and a copy shall be filed in Complaint File.
All forms, documents and correspondence associated with the complaint shall be identified with the complaint number and filed in the complaint file.
Each written complaint shall be maintained for at least one year after the expiry date of the drug product or one year after the date on which the complaint was received, whichever is longer.
In case of certain drug products lacking expiration dating, the written complaints shall be maintained for 3 years after distribution of the last lot of drug product or 1 year after the date on which the complaint was received, whichever is longer.
A trimonthly status report of complaints shall be generated by Head of Quality Assurance department and forwarded to Management review committee comprising of Division Head and all departmental heads for a detailed review.
The status report of complaints shall be filed in the complaint file.
If the same batch of a product is distributed in more than one country and complaint is received from a country, then the status of the product in other countries shall also be investigated depending upon the nature of the complaint and the Regulatory Authority / (s) of the country / (s) shall be informed.
Forms and Records (Annexures)
Specimen format of “Complaint Information Form” – Annexure 1.
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure 1.
Specimen format of “Complaint Information Form” –
COMPLAINT INFORMATION FORM
- Complaint No.: ____________Date : ___________________
- Product name & Strength : ___________Batch/Lot No. :: _____________Batch/Lot Size :: ____________
- Expiry Date :: _______________Manufactured by & At : _____________
- Complainant’s Name /Company: ____________________ Complainant’s Address: ______________
- Complainant’s Phone No. :_____________Complaint Received Via MAIL/PHONE/FAX/OTHERS
- Sample available: Yes / No
- Sample received on : __________________Amount of samples sent :________________
- Nature of Complaint:_________________ Signature /Date :________________
- The final response to the complainant given on ________________________