I was asked today if I am a good Judge to identify if a market complaint is a fake.
Or is it a genuine, to understand that there very important aspects that one must know are.
Product history, knowledge about competitors product, and the ability to find out genuine root cause.
If you can identify the root cause of a market complaint then you have opportunity to improve the defect.
If you are not able to identify the root cause then its not favorable to product, it may harm further it may lead to defective products.
So its important to judge if the market complaint is genuine or a fake. Quality assurance department follow the method provided over here and carry out root cause analysis accordingly.
Good manufacturing practices guidelines and FDAs guidelines mention that a pharma manufacturer must have system to handle market complaints, Systems to identify root cause of a Deviation or a Incidence or system failure, and must have system to implement and measure effectiveness of corrective and preventive actions, systems to judge the risks and systems to mitigate them.
In event of presence of any of the discrepancy in them the pharmaceutical manufacturing facility do not meet the guidelines. The medicine manufactured in such company is termed to be substandard and adulterated.
Even if the product do meet all analytical standards of product like Assay, strength, packaging, number of units, dosage, labeling requirements are correct the purity is fine.
Certificate of analysis is made and found in compliance, the all standards are meet.
And the pharmaceutical manufacturing firm do not meet the requirements of proper handling of market complaint. Then it is termed to be a substandard product as per the Guidelines of US FDA.
How to handle a market complaint. Details are provided here.
https://timesofpharma.com/handling-investigation-market-complaint-drug-product/