Explanations of the interpretations and uses of certain product quality issue terms (e.g., coating incomplete”) are found in the MedDRA Introductory Guide (Appendix B, “Product MedDRA Concept Descriptions). Product quality issue reported with clinical consequences If a product quality results in clinical consequences, term(s) for the product quality issue and the clinical consequences should be selected. Example Reported LLT Selected Comment Product abnormal New bottle of drug tablets have unusual chemical smell that made Nauseous me nauseous Product substitution I switched from one brand to brand to brand another of my blood pressure medication, and I developed Smelly breath smelly breath Consumer noted that the toothpaste they had purchased caused a stinging sensation in Product counterfeit the mouth. Subsequent investigation of the product lot Stinging mouth number revealed that the toothpaste was a counterfeit product. Patient reported severe burning in Nasal burning his nose after using nasal drops Specific product defects Product appearance that had a cloudy appearance. An and issues with cloudy investigation by the manufacturer manufacturing systems revealed that impurities were Product impurities may be reported found in the batch of nasal drops subsequently as part of a and that these had been Manufacturing root cause analysis introduced by a faulty piece of equipment equipment. Product quality issue reported without clinical consequences It is important to capture the occurrence of product quality issues even in the absence of clinical consequences.
Explanations of the interpretations and uses of certain product quality issue terms (e.g., “Product coating incomplete”) are found in the MedDRA Introductory Guide (Appendix B, MedDRA Concept Descriptions). Product quality issue reported with clinical consequences If a product quality results in clinical consequences, term(s) for the product quality issue and the clinical consequences should be selected. Example Reported LLT Selected Comment New bottle of drug tablets have unusual chemical smell that made me nauseous Product abnormal Nauseous I switched from one brand to another of my blood pressure medication, and I developed smelly breath Product substitution brand to brand Smelly breath Consumer noted that the toothpaste they had purchased caused a stinging sensation in the mouth. Subsequent investigation of the product lot number revealed that the toothpaste was a counterfeit product. Product counterfeit Stinging mouth Patient reported severe burning in his nose after using nasal drops that had a cloudy appearance. An investigation by the manufacturer revealed that impurities were found in the batch of nasal drops and that these had been introduced by a faulty piece of equipment. Nasal burning Product appearance cloudy Product impurities Manufacturing equipment Specific product defects and issues with manufacturing systems may be reported subsequently as part of a root cause analysis Product quality issue reported without clinical consequences It is important to capture the occurrence of product quality issues even in the absence of clinical consequences.
000012_termselptc_r4_13_mar2017_RL.docx