Product Complaints – Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for
distribution ,When a customer or any other party (internal or external) has reported a product defect or adverse event with any of the company’s marketed products and to establish and maintain procedures for receiving,
reviewing, and evaluating complaints by a Formally Designated Unit to ensure:
Processing in uniform and timely manner
Documentation of oral complaints upon receipt
Evaluation to determine if failure investigation
To lay down a procedure to investigate, document and respond to product complaints.
This Standard Operating Procedure shall be applicable to all pharmaceutical drug products manufactured or marketed by (Pharmaceutical Company Name).
- Head, of Marketing, shall be responsible for forwarding the complaints received from sales representatives, customers, etc. to Quality Assurance Department.
- All other Department Heads, if receive any product complaint, shall be responsible for forwarding the same to Quality Assurance Department.
- Head, Quality Assurance shall be responsible for coordinating and processing all product complaints except product complaints related to or from regulatory agencies and product complaints related to Adverse Drug Reactions / Adverse Drug Events; however, Head, Quality Assurance shall be responsible for sending the final reply of the complaint to complainant and final disposition of all product complaints.
- Head, Regulatory Affairs department shall be responsible for coordinating, processing and responding to all product complaints related to or from regulatory agencies.
Accountability: The head – of QA and RA shall be accountable for the compliance of the SOP.
NOTE: – Every person who deals with the product complaint shall be responsible and accountable for taking prompt action at his level giving top priority to the matter.
Abbreviations and Definitions
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- RA: Regulatory Affairs
- CAPA: Corrective and preventive action
Product complaint shall be defined as any product-related complaint received from the customer regarding the efficacy/quality/purity of the product which may/may not affect the health of the customer. Product complaints can be broadly classified as 1. Critical 2. Major 3. Minor
Critical complaints: include those where the efficacy of the product is in question e.g. label mix-ups, overdosing, or some critical side effect or adverse drug reactions which may cause the death of the patient.
Major complaints: include those which may put the patient at some risk but are not life-threatening and are quality related e.g. assay is low, broken/half tablets found, lamination problem, layer separation in case of bilayer tablets, mottling or color defending problem in case of coated tablets, molten tablets, broken capsules, microbial growth, insect or insect residue found, deformed capsules, less volume, suspended impurities in solution, breaking of suspension, leakage of tubes, carton/foils without proper overprinting details, missed overprinting, etc.
Minor complaints: include those which are not life-threatening e.g. shortage or excess quantity received by stockiest, empty pockets, improper sealing, etc.
Any product complaint received by any department shall be forwarded to the QA Department for log in and assign a number to the complaint as per Annexure-I.
The complaint in original shall be attached with the complaint format and its copy shall be retained by the Department who forwarded the complaint.
The Marketing personnel or whosoever receiving the complaint shall forward the same with details and original to QA through mail/phone/hardcopy.
Complaints where Regulatory bodies are concerned, the receiving department shall forward the complaint directly to RA. In this case, RA shall get the complaint logged and product complaint number assigned from QA. Then RA shall initiate the investigations or evaluation of the complaint and shall reply to the concerned regulatory body. Thereafter, the copy of the reply along with Product Complaint Form shall be given to QA for closing of the complaint.
For all other complaints except the mentioned above, the final reply to the complainant shall be send by QA.
The complaint shall be forwarded to the QA for registration. QA shall fill the complaint information form and forward the complaint information form to appropriate department(s) for further investigation. The type of complaint shall be identified and investigated accordingly. Investigation of the market complaint shall include, as relevant but shall not be restricted to investigation of batch manufacturing records, control samples, analysis reports and deviation reports, if any.
Product complaints shall be referred to the concerned departments as appropriate. However, based on the exact nature of the complaint, QA shall decide on the relevant department for investigation.
Each complaint shall be assigned a unique number consisting of 9 alphanumeric characters by QA as PC/XXX/YY where:
- PC: stands for Product Complaint
- / : ‘slash’
- XXX : serial number of compliant e.g. 001, 002, 003 etc.
- / : ‘slash’
- YY: stands for the calendar year i.e. 23 for 2023.
- e.g. the first complaint received in 2023 shall have the complaint number as PC/001/23.A new series of the complaint number shall be started at the beginning of a new year.
QA shall fill in the information in the ‘Product Complaint Form’ (Annexure-I).
QA shall decide if any additional information is required regarding the complaint, if so, QA shall obtain the same.
QA shall record the product complaints in Product Complaint Logbook as per Annexure-II.
The complaint receiver (i.e. Marketing/Export/QA/any other department Head) shall send the complaint acknowledgment to the complainant. Based on the nature of the complaint, if the complaint receiver in coordination with QA, feels that the investigation can be completed within seven working days, then the initial acknowledgment can be avoided and a final reply of the investigation shall be sent to the complainant.
The concerned department(s), investigating the complaint shall document their findings in the Product Complaint Form as per Annexure-I. If additional space is required, additional pages may be used.
If required, CAPA shall be filed as per SOP on Corrective and Preventive Action (CAPA).
The investigation report and necessary CAPA shall be submitted back to QA, and complete in all respects within 7 working days.
Based on the findings of investigations by the concerned department or report sent by the Regulatory Affairs department to the regulatory body/complainant, Head QA shall give a final reply to the complainant and shall finally give the disposition in the Product Complaint Form (Annexure-I). If the receipt of acknowledgment of reply is available same shall be addressed in disposition in the Product Complaint Form.
During the course of the investigation and the final disposition, if it emerges that there is a need for product recall then the SOP titled “Product Recall” shall be followed.
Once the investigation is complete, Head QA shall send a reply to the complainant and to the Department head receiving the complaint or his/ her designee.
All forms, documents, and correspondences associated with the complaint shall be filed in the Product Complaint File.
Each written complaint shall be maintained for three years after the expiry date of the drug product.
Any market complaint received shall be closed in a period of not more than 45 days. However, for any particular case, if the investigation takes more than this period, QA shall inform the concerned department Head (i.e. the department that has received the complaint), who in turn shall inform the complainant.
There shall be an annual compilation and review of all the market complaints product-wise.
Forms and Records (Annexures)
- Production Complaint Form: Annexure-I
- Product Complaint Log Book: Annexure-II
- Flow Chart (Product Complaint Investigation): Annexure-III
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores, Purchase,Sales, Regulatory Affairs.
|Date||Revision Number||Reason for Revision|
Annexure – I
Product Complaint Form
I. Product Complaint No.:………………………………………………..
Part A (Preliminary Investigation Form)
1. Complainant’s Information
Complaint received via
Complaint received on
2. Product Information
- Generic Name
- Mfg. Date
- Pack Size
- Batch No.
- Exp. Date
3. Brief Description of Complaint
4. Complaint Received By
Complaint forwarded to QA / RA Department on:
II.Part B (Investigation Report)
Complaint Received in QA by: Complaint received in QA on:
Complaint received by QA via:
Complaint No. :
1. Sample Information
- If samples are available – Yes/ No
- If yes, then mention Quantity
- Condition of samples
- Date samples received
- Detail of any other enclosure with a sample like a packer’s slip
2. Description of Complaint
3. Investigation by the relevant department
4. Proposed Corrective and Preventive Action
Is recall of product needed:- Yes / No (if yes then follow the SOP on Product Recall)
5. Disposition by Quality Assurance
Head of QA
Annexure – II
Product Complaint Log Book
- S. No.
- Date of Receipt of Complaint
- Source of Complaint
- Type of Complaint
- B. No.
- Details of Complaint
- Details of Investigation
- CAPA No.
- Reply Letter No. & Date
- Investigation Completed on