Handling of Market Complaints in Pharmaceutical Industry: A Review
Journal Title: Journal of Drug Discovery and Development - Year 2018, Vol 2, Issue 2
Abstract
Pharmaceutical products lunch to the market can receive a “Market Complaint” by the customer to the manufacturer via mode of complaint registration, if the product does not meet the defined registered requirements.1-4Pharmaceutical products are considered of high quality requirements, due to use of the product by patient and are likely to have a serious and fatal impact on the patients, hence the product is been reviewed for quality, identity, purity and/ or safety and are likely to have a serious and fatal impact on the patients.10Handling of the Market complaint is the responsibility of the Quality Assurance department and hence a strong quality assurance team needs to be present at plant to handle such issues.3&7In this review article, we have tried to address the important aspects of market complaints, its various types, its handling, and investigation and reporting.Market Complaints are classified into following categories to facilitate the investigation:1&10Minor Market Complaints:The Complaints indicating no significant impact on product quality, identity, purity and safety is categorized under minor complaints.Major Market Complaints: The Complaints indicating impact on product specification, identity, purity and safety are categorized under major complaints.Critical Market Complaints:The Complaints indicating significant impact on product quality, identity, purity and safety and are likely to have a serious and fatal impact on the patients are categorized under critical complaints
Authors and Affiliations
Anupam Gulabdhar Pandey
Keywords
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