How to handle investigate and identify root cause of a market complaint of a drug product.

How to handle market complaint in pharmaceutical industry? One of the prime objective of addressing the market complaints or product complaint received from user is to 1) Prevent any loss to patient due to malfunctioning or faulty product. 2) To maintain the quality of the product by learning the root cause of the defect and providing mitigation to it through corrective and preventive action so that the same kind of defect is not found in marketed product. 3) To maintain the reputation of product and company with patients and doctors. 4) Finally, to avoid the actions which might be taken on a pharmaceutical company for defective product by FDA or regulatory agency.

Therefore, a proper approach must be provided to handling and investigation of market complaint in any given pharma company.
How to handle a market complaint?
Immediately within 12 hours of time the market complaint must be sent to QA department.
QA dept. within 24 (of hours working days’ time limit may vary company to company) must log the market complaint and respond to the sender for receipt of the market complaint.
If the market complaint in genuine further it must be given to production or the originating department for their input on investigation. Within 7 days’ time the primary investigation must be done and a primary report mentioning if the complaint is genuine or non-genuine must be reported.
How to classify Major, Minor and Critical nature of market complaint. Is it required to prove reply to person who gave a complaint regarding drug product?
Every market complaint must be logged, and categorized as minor, major critical, if the market complaint is regarding the pharmacological efficacy or effect of the drug product efficacy product standard, or if it affect the life of patients during the usage of the drug product, then it must be categories as Critical, if the defect might not affect pharmacological efficacy or assay or any standards of product but the possibility cannot be denied then such complaints should be classified as major.
The complaints which do not affect drug product quality, pharmacological efficacy, patients’ lives during usage, or do not Detroit the product such complaints can be classified as minor.
Within seven days of the complaint is logged a primary report where an investigating team after detailed investigation should submit to quality assurance dept.
After which a communication may be provided to the customer that their complaint is investigated and the root cause identified is been mitigated.

Next important part of this article is Investigation of Market complaint. How to do investigation of market complaint of a drug product?
Complete understanding of product pack, product pharmacology, product chemistry and production process is required to gain before one do investigation on particular drug products market complaint.
Why it’s important to investigate a market complaint.
Genuine root cause identification is required to be identified so that corrective action and preventive action CAPA can be implemented and the defective drug product being distributed to market is prevented, which is the basic important task behind the logging and investigation of any market complaint of a drug product in a pharma company.
How to investigate and identify root cause of a market complaint of a drug product.
A scientific approach must be provided, the identified root cause should replicate the defect if a challenge mock test is performed, by creating the same defect as found in root cause.
Therefore, the best tools to arrive at root cause is 1) to conduct experimentation, if the investigator is well experienced then he might identify the process steps which might be critical to generate defect. 2) To conduct why why analysis till a satisfactory answer is found for the defect reported in market complaint. 3) Ishikawa Fish bone diagram. 4) Man, Material, Machine, Method, Mother Nature Five M analysis.
Why why analysis or any of the above tolls should be combined with brain storming sessions and the inference arrived in brainstorming sessions or any other tool used and the outcome of why why analysis should match or there might be two root causes identified by with different methods of investigation, which might be equally important to mitigate through CAPA.

Legal aspects of Market Complaint handling:
If a company do not have adequate system to handle and investigate and to do mitigation of market complaints the drug product produced in such a company is considered as substandard and spurious as per the US FDA guidelines therefore its very important aspect of pharmaceutical Quality management system. A team of experts in particular subjects can be formed to do investigation to identify root cause. (RCI team)
Finally after completing of the investigation of a market complaint a reply in a proper format may be given to the individual who raised the complaint a company may mention in it the care taken to eliminate the root cause.