Product complaints in pharmaceuticals

Rahul Kashyap
0

Purpose

To lay down the procedure for receipt, record, classification, investigation cause and CAPA, response, closure, trending of Product Complaint to ensure that all product complaints are handled in accordance with the regulatory requirements and are appropriately responded to satisfy customer and avoid repetition.
Procedure

Definition

Any type of "un-satisfaction" received from consumer against product (it may be deficiency in strength, identity, safety, purity or the quality of the products.
Classification of Complaint:
Critical: Which directly affects the quality, safety, purity, identity and strength of product and making the product unsafe for consumption. Serious complaints pertaining to product quality non-conformances, confirmed adverse reactions & probability of spurious drugs, Product Batch mix-up.
Major: Which indirectly affects the quality, safety, purity, identity and strength of product and may make the product unsafe for consumption. Complaints pertaining to batch coding, improper spray pattern, actuator missing etc.
Minor: Complaints which do not have potential to cause death or permanent physical disability to the consumer and does not fall in above mentioned two classifications. Complaints pertaining to Shortages, Empty can or Short fill in can, temper seal damaged etc.
Receipt of Complaint:
Product complaint may be received orally / telephonically / e-mail from various sources at Head -QA, Depot, Sales & Marketing, customer or other department/ Location/ agency/ authority (hereafter called as "Originator"), shall be sent/forwarded/informed to Head -Quality.
Complaints shall be sent / informed to Head–QA in the prescribed format “Complaint Form.

Logging of the Complaint:

On receipt of the complaint the Head-QAD shall acknowledge the receipt of complaint within two working days.
Head-QAD shall evaluate the genuineness, intensity and nature of complaint.  Any additional information if required, it shall be forwarded to the complainant / initiator of complaint.
Head-QAD/Designee or the receiver of complaint shall insist for complaint sample with original packaging details along with storage conditions of sample (Wherever possible and applicable).
Head-QAD/Designee shall categories the complaint on basis of nature of complaint and investigation and keeping in mind impact of complaint on complainer/customer and user. 
Categorization of the complaint can be done by using relevant tool of Quality Risk Management like Brain storming etc.
The nature of complaint shall be categorized as:
Physical Appearance Related.
Process related.
Analytical Related.
Medical related.
Packaging related.
Storage and Transportation related.
Shortage related.
Others.

Handling, Counterfeit of Complaint Sample:

Executive/Designee-QAD shall receive the complaint sample.
Executive/Designee-QAD shall check the complaint sample for its genuineness and keep the sample under lock and key until closure of complaint.
When the retained sample is within the specification but the complaint sample does not match, complaint sample shall be considered as a counterfeit or tampered product. Further Investigation is not required in such cases. 
The Legal affairs and the competent authorities or customer must immediately be informed for further action (if required).
Executive/Designee-QAD must also check if the complaint represents a serious and unexpected adverse experience, which is required to be reported to the health authorities, according to the specific safety reporting regulations of the respective countries.

Initial feedback & review

Executive/Designee-QAD shall send the initial feedback (where investigation requires more time) to the customer within 24 to 48 hours and it shall include:
Acknowledgment of the complaint.
Additional information/ sample, if required.
Counterfeit/Tamper Suspicion (If Complaint Sample Available).
Review of Reserve sample and results of its analysis, if available.
Evaluation of customer’s sample, if evaluation is over, if applicable.
Executive/Designee-QAD shall communicate the authority, customer regarding product complaint based on the nature of complaint.
Executive/Designee-QAD shall record the complaint in the “Complaint Register”

Investigation:

Investigation shall include following steps:
Initiation of Investigation
Collection of Data
Identification of possible factors (Root Cause Analysis)
Summarization and Completion of Investigation

Initiation of Investigation:

Investigation shall be initiated to identify the non-compliance or suspect quality issue. It shall be compressive so as to understand the fundamental or underlying cause of the discrepancies and to find the solution so that reoccurrence of the problem does not take place. The aim of the Investigation is to identify the incident, ascertain the probable causes of incident and to suggest and implement corrective and preventive actions to eliminate the cause & recurrence.
Collection of Data:
Executive/Designee-QAD shall collect the data/documents needed to carry out the investigation as per SOP of “Root Cause Analysis”. Data shall be collected from various sources but not limited to the following:
General sources: Previous Similar Investigations, APQR data and interview of associated personnel.
Analytical Data: In process, finished product, Stability and hold time study data.
Process Deviations: Process/Packaging validations, cleaning validations, batch   manufacturing and packing record of complaint batch.
QMS Review: Deviations, OOS/OOT if observed during processing of complaint batch.
Equipment/instrument logs: Preventive Maintenance/Breakdowns.
Raw Material nonconformance: Raw material receiving test procedures and testing reports.
Environmental Monitoring: Microbiological trend data, temperature and humidity data.
Data for each question such as what specific system/process has the problem shall be collected. Data can also be collected by discussion with personnel from concerned department to carry out the investigation.

Review of Documents:

Documentation based investigation shall be carried out by review of documents. It consists of checking if this complaint occurred previously in the other lot or if any non-conformance was found in the lot during its manufacturing or packing that could explain the complaint.
The primary documentation to be reviewed consists of the complaint log and the batch records. Complaint log can be checked that how many other complaints of the same nature had occurred and how they were handled.
Batch records shall be verified in order to see if there was any non-conformance during the production that can explain or confirm the quality deviation, and how it was investigated and concluded. In-process checks details during the processing of the batch shall also be checked.

Identification of possible factors (Root cause Analysis):

Executive/Designee-QAD shall carry out the investigation by Identifying possible contributing factors (Root Cause Analysis) as per SOP of “Root Cause Analysis”, and by analyzing the situation from different perspectives.
The scope shall determine (but not limited to) the area under investigation, the duration under investigation, the activity under investigation, the document under investigation, the equipment/instrument under investigation etc.
A comprehensive root cause analysis shall be performed for the investigation of discrepancies. Tools can be used on the basis of identification of assignable cause or root cause.
Appropriate investigation techniques (tool) shall be used to determine the root cause as per SOP of “Root Cause Analysis”
Based on the nature of the complaint, it shall be forwarded to:
Quality Control Department
Production Department
FRD Department
Quality Control: Complaints requiring analysis, including suspected contamination / adulteration or mislabeling.
Production: For quality and packaging related complaints.
FRD: For ADR related and technical review.
Head-QAD/Designee shall be responsible for coordination and completion of the investigation report.

Laboratory Investigation done by quality control department: 

Executive/Designee-QCD shall examine the reserve sample of the complaint batch and check for physical observations, and also compare the reserve sample with the complaint sample, if received along with the complaint.
If the complaint is related to the quality attributes, quality control analysis records shall be reviewed.
If required, calculations and test records shall be checked for calculation mistakes, instrumental errors, and deficiency in the sampling or sampling errors.
If needed the reserve sample and complaint sample (if received) shall be analyzed, for ensuring the quality of the product.
Comparison of the results of analysis of the reserve sample and customer’s complaint sample with those obtained at the time of release of the batch shall be done.
Executive/Designee-QCD shall send the results of analysis along with the supporting documents to QA for further action, if, the results are within the specifications and analysis do not reveal any problem w.r.t. batch.
If results indicate non-conformance to the specifications further investigations shall be carried out.
Re-Examine/Re-Test preceding and succeeding batches, Review the stability records if required.
Executive/Designee-QCD shall send the results of laboratory investigation to QA along with all supporting documents, i.e. calculations, graphs, chromatograms, spectra etc.

Corrective & Preventive actions:

In case laboratory investigation reveals that the original results were not correct,
review the checking mechanism of the results and re-qualify the analyst.
If the results of laboratory investigation indicate that the product does not   conform to specifications full failure investigation shall be carried out.
If observed that the problem was on account of the original sample, review the     sampling procedure or re-train & re-qualify the chemist responsible for             sampling.
If the results of laboratory investigation indicate that the reserve sample     conforms        to specifications, while the complaint sample does not conform reasons for the possible product failure shall be explored with production and      FRD.
In case of proven product failure, Head-QAD shall take up the matter with FRD    for further study and review of the process to address the problem.

Production (Manufacturing / Packing) Investigation done by Production & QA:

Executive/Officer/Designee Production and QA shall review the packaging and labeling records.
If the specimen label and overprinting details on the label are correct and checked by production and verified by QA. If the line clearance was carried out and signed by both Production and QA.
In case no problem is found, examine the feasibility of checking the consignment at the customer’s place to ascertain the cause and take appropriate corrective and preventive action.
Missing batch coding or improper spray pattern is considered to be a critical mistake as it may tantamount to mislabeling or misbranding.
Empty can, low fill weight actuator missing or damage etc.
Damage to the consignment shall be verified.
Shortages related to quantity missing etc.
Factors that can contribute to the shortages shall also be examined.

Corrective and Preventive action:

In case the complaint relates to wrong batch coding mistake product recall shall be immediately initiated.
Labeling and packaging operations & systems shall be reviewed and more rigid    controls shall be introduced.
Monitoring the activities of personnel at the packaging belt.
Possibility of pilferage shall be ruled out.

Investigation Period:

In case of critical complaint, investigation shall be completed within seven working days after receipt of complaint. However, product recall if required shall be initiated within 48 hours of receipt of product complaint.
In case of major complaint, investigation shall be completed within three weeks after receipt of complaint.     
In case of minor complaint, investigation shall be completed within four weeks after receipt of complaint.

Summarization and Completion of Investigation:

The information from all concerned departments involved in investigation shall be complied and summarized in the “Investigation of product complaint”.
QA shall make an investigation report based on the information, highlighting all the findings, risk assessment, proposed corrective actions, where required, steps taken – where applicable to prevent the recurrence of the problem.

Closure of complaint:

Head-QAD shall review the investigation report and outcome of investigation along with CAPA and ensure that there is effective implementation of CAPA to eliminate reoccurrence of complaint.
Executive/Designee-QAD shall ensure the adequacy and completeness of the investigation report.
Head QA shall approve the investigation report.
Executive/Designee-QAD shall send the investigation report to the customer or to the regulatory bodies.
QA shall preserve all the data pertaining to the investigation as well as final conclusions, corrective and preventive actions and the complaint shall be treated as “Closed”.
If any complainer wants to reopen the closed report then it can be reopened within seven days after closing of report, based on management decision and on the basis of criticality of complaint with supporting data provided by complainer.
In case complaint is not closed within defined timeframe justification shall be filled by Head-QAD/Designee for delay in closure.

Trending of Complaints:

Product Complaints shall be reviewed on quarterly basis for indication of specific or recurring problem requiring attention and possible recall of marketed products.
The trend report shall be prepared in order to take CAPA to avoid recurrence.
A brief summary of Product Complaints received, shall be addressed in APQR to identify the Corrective and Preventive Actions (CAPA) and its effective implementation.
Trend of complaints including details of critical Product complaint shall be discussed in Management Meeting.


Post a Comment

0Comments
Post a Comment (0)