SOP on Handling of Product Complaints
Objective : To lay down a procedure to investigate, document and respond to the product complaints.
Scope : This Standard Operating Procedure shall be applicable to all pharmaceutical drug products (formulations) manufactured or marketed.
Responsibility
Head, Marketing of the concerned division 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.
Head, Clinical Research department shall be responsible for coordinating, processing and responding to all product complaints related to Adverse Drug Reactions / Adverse Drug Events.
Procedure :
Product complaint shall be defined as any product related complaint received from customer regarding efficacy/quality /purity of the product which may/may not affects the health of the customer. Product complaints can be broadly classified as Product complaint Critical /Major /Minor.
Critical complaints: include those where efficacy of product is in question for e.g. label mix ups, overdosing or some critical side effect or adverse drug reactions which may cause death of the patient.
Major complaints: include those which may put patient at some risk but are not life threatening and are quality related. For e.g. assay is low, broken/half tablets found, lamination problem, layer separation in case of bilayer tablets, mottling or colour defading 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. For e.g. shortage or excess quantity received by stockiest, empty pockets, improper sealing etc.
All quality complaints related to packaging or the quality of the products shall be directly received or referred to QA. Any complaint received by Marketing Department, Exports Department or any other department on product quality shall be referred to QA for logging and assigning number to the complaint.
The Marketing personnel or whosoever receiving the complaint shall forward the same with details and original to QA through mail/phone/hardcopy.
QA shall fill in Complaint Information Form with Complainant Information and a brief description of complaint.
QA shall then forward the complaint to the concerned department for further investigations. In case, where Complaints wherein 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 Complaint Information Form shall be given to QA for closing of the complaint.
Complaints related to adverse events, serious adverse events (SAE), or serious adverse drug reaction (ADR) shall be referred directly to Clinical Research Department through Complaint Information Form. Clinical Research department shall get the complaint logged and product complaint number assigned from QA before initiating the investigations or evaluation of the complaint as per SOP. Clinical Research department shall reply to the complainant. Thereafter, the copy of the reply along with Complaint Information Form shall be given to QA for closing of the complaint.
For all other complaints except the above mentioned , 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 complaint shall be referred to the concerned departments as appropriate e.g. complaints received from outside drug analysts shall be referred to Quality Control and / or Production, stability related issues shall be referred to R&D and packaging related issues to Production. However, based on the exact nature of the complaint, QA shall decide the relevant department for investigation
On receiving complaint forwarded by Marketing or any other department, each complaint shall be assigned a Eight-character number by QA in the form PCXXX/YY where:
PC : stands for Product Complaint , XXX : serial number of compliant e.g. 001, 002, 003 etc. , / : ‘slash’ ,YY : Last two numbers of the calendar year i.e. 25 for 2025.
e.g. the first complaint received in 2025 shall have the complaint number as PC001/25. A new series of the complaint number shall be started at the beginning of a new year.
QA shall fill in the information in ‘Complaint Information Form’ . The QA personnel shall mention details regarding Sample Information and description of complaint and if any additional information is available then that is furnished in the form.
QA shall decide if any additional information is required regarding the complaint. If so, QA shall obtain the same.
QA shall maintain a logbook of receipt of product complaints.
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 co-ordination 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 Complaint Information Form. If additional space is required, additional pages may be used. If required, CAPA shall be filed.
The investigation report and necessary CAPA shall be submitted back to QA, complete in all respects within 7 working days.
Based on the findings of investigations by the concerned department or report sent by Regulatory Affairs and Clinical Research departments to regulatory body / complainant, Head QA shall give final reply to complainant and shall finally give the disposition in the Complaint Information Form. If the receipt of acknowledgement of reply is available same shall be addressed in disposition in the Complaint Information Form.
During the course of investigation and final disposition, if it emerges that there is a need of product recall then the SOP titled “Product Recall and Handling of Recalled Products” shall be followed.
Once the investigation is complete, Head QA shall send copy reply send to complainant 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 who 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.