To lay down a procedure for receipt, investigation, review and response of market complaints
- In charge / Designee – Quality Assurance shall be responsible
- For handling market complaints
- Maintaining relevant documents and market complaint register.
- Keeping the procedure current and applicable
- In charge– Quality Control and In charge – Production
- Assist in investigation of the market complaint
- In charge – Marketing.
- Responsible to provide all relevant information on market complaint.
- Head – QA –Ensure implementation /compliance of this procedure.
- Qualified Person of respective contract Mfg- For contract Mfg Products-To provide all relevant information on market complaint.
- Any complaint received for the marketed product from the end user, customer, retailer, distributor or field staff or marketing manager regarding the purity, efficacy, labeling defect, or any other such complaint shall be considered as a Market Complaint.
- Any communication in written or verbal, received directly or through respective country manager /representative shall be considered as a complaint.
- Wherever possible efforts shall be taken to get the complaint sample. If complaint sample not available, investigation shall be carried out with the control sample based on the nature of complaint. After receiving of the sample the same shall be kept as per storage conditions mentioned on the sample till investigation of complaint.
- Country Manager/representative shall send a copy of correspondence received from the complainant and a complaint sample (if available) to In charge – QA/designee.
- Control sample shall be taken from the control sample section by sending communication.
- On receipt of complaint, In charge – QA/designee shall document the following details in the Market complaint register.
- Complaint number
- Date of receipt
- Product Name & Strength
- Batch Number
- Date of manufacture
- Date of expiry
- Name, address and telephone number of the complainant
- Nature of the complaint.
- Replied on
- Corrective and preventive action
- Disposition date
- After receiving the complaint sample,(If available) In charge – QA/designee shall document the details in complaint sample register.
- Complaint receiving date.
- Complaint number.
- Complaint sample receiving date.
- Product Name.
- Batch Number.
- Complaint received from.
- Number of samples received.
- Investigation for physical examination / Analysis.
- Investigation completed on.
- The market complaint received shall be assigned with an alphanumeric numbering system market wise:
C – Complaint
Z – U/E/O/B
U for USA Market. & E for Europe Market. & O for Other Market. & B for Brazil market.
XX – Market complaint number
YY – Year of the market complaint
Example: First complaint received from US market in 2020 shall be numbered as follows:
- If any complaint sample is received, the same shall be labeled with the complaint number.
- Each complaint shall be entered into the “Market Complaint Information form”
- A personnel shall send a field alert report, where required, within two working days to concern regulatory authority as per SOP
- Note: Complaint received, for the product not marketed, from any contract manufacturer or from our warehouse or distribution center shall also be investigated and records to be maintained. The numbering system for the complaints shall be five characters and mentioned below:
Where C – Complaint, XX is the serial number and YY is the year of the complaint.
- Complaint shall be classified as follows to facilitate the investigation
- Packaging complaints
- Quality complaints
- Medical complaints
- Packaging and Quality complaints shall be jointly investigated by QA In – Charge, Manager – QC, Formulation Research Development In-Charge and Production In- Charge.
- The following shall be considered while investigating the Packaging / Quality complaints:
- Inspection of the defective product received.
- Analysis of the defected product if required.
- Review of the batch processing and packaging records.
- Physical examination of the reference sample.
- Analysis of the reference sample.
- Before starting of investigation of market complaint, complaint information form to be filled as per available information, during investigation all supportive documents which were reviewed and collection of documents (If required) and other information to be filled as per the market complaint checklist at the end of investigation the same should be retained along with investigation report.
- Wherever required Medical complaints shall be investigated in co-ordination with medical doctor or equivalent or pharmacovigilance coordinator.
- Investigation shall be extended to other batches, which were manufactured with same Raw Material and primary packaging material during same time period and likely to be affected.
- A manager or designee in co-ordination with the concerned departmental head shall arrange for review of the batch documents for any abnormalities, deviations, and incidents. Where necessary the equipment /instrument usage logs, personnel training records, stability data, trends etc.shall be reviewed.
- QA Incharge shall arrange for the examination of complaint sample, where available, along with the reserve sample of the complaint batch as necessary.
- Check if similar complaints have been received earlier, during the last one year. If the complaint is repeated, check and ensure whether the preventive actions proposed have been implemented and are effective.
- Wherever applicable the Investigation shall be carried out as per SOP failure investigation and various investigation tools shall be used to find out the probable root cause and reports shall be summarized. After completion of the investigation, incharge Quality Assurance shall discuss the findings with Head – Quality Assurance.
Refer Investigation tools used in pharmaceuticals https://pharmaceuticalupdates.com/2020/02/10/investigation-tools-used-in-pharmaceuticals/
- The Quality Assurance incharge along with the concerned departments In-charge and Head- QA shall propose the necessary corrective and preventive actions to avoid the reoccurrence of the complaint.
In case of any intimation of market complaint received from contract giver a detail investigation shall be carried out and shall be forwarded to Qualified Person or equivalent designee of contract giver for necessary action.
- If the investigation report concludes that the product will put the public at risk such complaints shall be referred to recall committee for taking recall decision .
- The complaint investigation report shall be written and filed in Quality Assurance department.
- Based on the complaint investigation report, Quality Assurance shall communicate the appropriate conclusions stating whether the complaint is substantiated or not to the concerned complainants or to the appropriate agency.
The investigation report shall be sent to the complainant with in 30 days from the date of the receipt of the complaint unless otherwise justified.
- Incase where Head – Quality Assurance finds that investigation is not necessary such written records shall be maintained including the reason for not conducting the investigation.
- After completion of the corrective action and preventive actions, complaint shall be closed.
- All the documents related to the Product complaints shall be retained for one year after the expiration date / one year after the date of receipt of the complaint whichever is longer.
- Based on the nature of complaint, trend shall be prepared once in a year.
- Quarterly summaries shall be prepared and forwarded to Director Pharma and Head– Quality Assurance for information.
- In case of any complaint which is already investigated and closed from the customer end, the same shall also be investigated at our site once again along with customer report.
- Handling of Market Complaint Samples
- The remaining complaint samples shall be maintained by incharge / designee QA at the storage conditions specified for the drug product for a period of one year after the expiry date of the drug product or one year after the date on which complaint was received which ever is longer.
- On completion of the specified retention period the samples shall be destroyed and record of it shall be maintained.
4.1 QA – Quality Assurance
4.2 QC – Quality Control
5.1 Product Recall.
5.2 Failure Investigation.
5.3 Field Alert
5.4 Sampling, storage and Destruction of Reference/Control samples
of Raw materials and Drug Products
6.1 Market Complaint Information Form.
6.2 Investigation form.
6.3 Requisition for reference samples / Complaint samples
6.4 Market Complaint check list.