PURPOSE
To define a procedure for handling market complaints.
SCOPE
This SOP shall be applicable to all the market complaints of drug products received directly or from any other source.
REFERENCE(S) & ATTACHMENT(S)
REFERENCE(S)
In House
CROSS REFERENCE DOCUMENTS
Document(s) and Data Control Procedure.
Change Control Management.
Corrective and Preventive Action (CAPA).
Quality Risk Management (QRM).
SOP on Investigations.
Handling, Management and investigation of Deviation.
Good Document Practice (GDP).
DEFINITIONS
Complaint: A market / consumer complaint is notification that a product in commercial distribution (which also includes physician sample).
May be in violation of the laws or regulations administered by the FDA (Drug Control Authority)
May have caused an illness, injury or death.
Is alleged to have caused problems not covered by the above.
Adverse Drug Event: It refers to any injury occurring at the time a medication or drug product is used, whether or not it is identified as a cause of injury.
Adverse Drug Reaction: All harmful and unintended response to a medicinal product related to any dose should be considered adverse drug reaction.
Attachment-I: Flow Chart for the handling of Market complaints.
Attachment II: Format of market complaint log at the manufacturing location.
Attachment-III: Format of Market Complaint Preliminary Investigation Report (PIR).
Attachment-IV: Examples of market complaints-guideline for investigation
Attachment-V: Format of Market Complaint Final Investigation Report (FIR).
Attachment-VI: Classification of market complaints
Attachment-VII: ADR Reporting Form
PROCEDURE:
SAFETY/PRECAUTION/EHS
NA
Source of Complaint: A complaint may be received from C & F agent, consumers, field source government agencies, trade sources & healthcare professionals or any other source.
Types of Complaints:
Complaints are categorized in 2 categories:
Quality Related: The complaints which are life threatening or cause serious adverse health consequences or do not match designed specification.
The Quality related problems are again divided into 3 categories as under:
Critical: They are the complaints which directly affect the health of the consumer or violates the law or regulations by drug regulatory authorities of India, FDA. e.g.
Reflecting poor quality, ineffectiveness, product deterioration, product mixing, batch coding problems, sterility problems, contamination like microbial growth & presence of foreign matter, product having low assay, failure of dissolution rate, product causing adverse effect / adverse reactions to the patient or death.
Major: These are the complaints which do not affect the health of the customer but
Causes him/her the financial loss and somehow or the other violates the laws or regulations administered by FDA. e.g. Marked change in description, smudged prints, empty pockets & tampering of shippers.
Minor: The complaints do not require immediate or prompt actions but may be investigated, referred or closed without further investigation at management’s discretion.e.g. Packaging complaints like shortage in intact shipper, shortage of strips, blisters.
Note: for more examples of classification of market complaint refer Attachment-VI.
Packing Related: The complaints do not require immediate or prompt actions but may be investigated, referred or closed without further investigation at management’s
Procedure for handling of complaints (Quality related):
Receipt & Registration: On the receipt of complaint from any of the source Q.A.Documentation section shall log the complaint, shall allocate the complaint registration number & shall forward it to the concern Department. The complaint registration number shall be allotted as under:
Investigation of the complaint:
Any quality related complaint investigation shall be completed within 30 days from the date complaint receipt, if does not demand for any additional work. If the investigation exceeds days reason for the same shall be documented & prior justification from QA head shall be taken.
In case of critical complaint where investigation may take time, location QA shall prepare PIR; as per Attachment-III & send to CQA within 2 working days of the receipt of Complaint (PIR may include but not limited to review of BMR / BPR / Control sample/Product literature / Trends depending on nature of complaints).
CQA shall send initial reply to the complainant if required, with or without replacement.
Site QA shall attach the PIR with the complaint, which shall be the part of market complaint investigation report.
Following are the examples of critical complaints.
Ineffectiveness
Melt back of lyophilized cake
Foreign matter
Colour change
Change in physical form
Adverse event/ Adverse drug reaction
Any quality defect that may cause Permanent disability or serious health consequences
QA shall conduct the investigation with the help of concern departments.
QA shall arrange for the physical inspection of control sample if required & shall prepare report of the same, which shall be part of the investigation report.
QA shall provide required quantity of control sample to QC for analysis if required.
QA shall provide required batch manufacturing documents to production or QC for review & data collection.
Production & QC shall provide required information to QA for the preparation of investigation report.
QA shall prepare FIR as per attachment V & shall get it reviewed and approved by the concerned persons
QA shall send copy of the final investigation report to CQA along with necessary attachments like control sample physical inspection report, trial batch report, quality control analytical data (in process trend, FP trend, stability data, complaint sample analytical results, control sample analytical results, trial batch results),training record or any other data .
CQA shall review the investigation report & ask for further investigation details, if required.
On receipt of FIR, CQA shall send final reply to the complainant, as required.
Reply to complainant:
In case of critical complaint, CQA shall send initial reply to the complainant, if required.
Subsequently, CQA shall send copy of initial reply to the concern location for the record.
After receipt of FIR, CQA shall send final reply to the complainant.
Copy of reply shall be send to Manufacturing location.
Procedure for handling of complaint- (Packaging related):
Receipt & Registration:
On the receipt of complaint from any of the source C.Q.A. shall log the complaint, shall allocate the complaint registration number & shall forward it to the manufacturing plant.
Investigation of the complaint:
Any packing related complaint investigation shall be completed within 45 days from the date of complaint receipt, if does not demand for any additional work. If the investigation exceeds 45 days reason for the same shall be documented & prior justification from QA head shall be taken.
QA shall conduct the investigation with the help of concern departments.
Location QA shall forward the complaint to the production/packing department.
Subsequently production/packing department shall check all the parameters required at the time of packing.
The production/packing head shall discuss the complaint with concern heads, impart the training, document the same and take other action as required based on investigation.
Department head shall send a copy of the training record to QA.
QA shall provide required batch manufacturing documents to production / packing department for review & data collection.
Production & QC shall provide required information to QA for the preparation of final investigation report.
QA shall prepare investigation report as per Attachment-V & shall get it reviewed and approved by the concerned persons.
A shall send copy of the final investigation report to CQA along with necessary attachments like training record, BPR & BMR or any other supporting documents.
CQA shall review the investigation report & ask for further investigation details, if
Reply to complainant:
After receipt of FIR, CQA shall send final reply to the complainant.
Subsequently, CQA shall send copy of reply to the concern location for the record.
Complaint Investigation Cycle Time:
Cycle Time (Quality related Complaints):
In the above mentioned case the PIR should be submitted within 2 days of registration.
FIR should be submitted within 30 days from the date of registration considering following two situations as under:
If complaint sample is available: FIR should be submitted within 30 days from the receipt of samples at the concerned location.
If the complaint sample not available: FIR should be submitted within 30 days from the date of confirmation of non-availability of complaint sample.
Cycle Time (Packing related Complaints):
FIR should be submitted within 45 days from the date of registration considering following two situations as under:
If complaint sample is available: FIR should be submitted within 45 days from the receipt of samples at the concerned location.
If the complaint sample not available: FIR should be submitted within 45 days from the date of confirmation of non-availability of complaint sample.
Six monthly review of complaints:
Quality review of complaints shall be done after every six months by manufacturing location, conclusion shall be drawn & CAPA shall be implemented by each location. The date of implementation of CAPA & effective B .No. shall be informed to CQA & the record shall be kept by CQA.
NOTE: Product Recall: In case of confirmation of critical complaints, product(s) shall
be recalled as per the product recall SOP of the manufacturing location.
