This risk assessment addresses the occurrence of intermixing of flavours during the manufacturing process of [Product Name]—specifically, the unintended combination of [Flavour A] and [Flavour B] in a single batch.
Flavours are critical excipients in pharmaceutical and nutraceutical products, as they:
- Contribute to product identity and label claim
- Affect organoleptic properties (taste, odour, appearance)
- Influence patient acceptability and compliance
- Carry potential allergenicity or sensitivity risks
- Are subject to strict regulatory compliance regarding accurate composition and labelling
This assessment has been initiated to:
✅ Evaluate the potential impact on product quality, safety, and compliance arising from flavour intermixing
✅ Identify root causes and contributing factors
✅ Assess the severity, probability, and detectability of the deviation
✅ Determine whether any regulatory reporting or market action is required
✅ Define corrective and preventive actions to prevent recurrence
The scope of this risk assessment includes:
- Review of manufacturing records, material traceability, and batch documentation
- Evaluation of process controls, equipment, and environmental conditions
- Analysis of potential patient impact and regulatory non-conformance
The goal is to ensure a comprehensive understanding of the deviation, quantify the associated risks, and reinforce the manufacturing controls necessary to maintain product quality, patient safety, and regulatory compliance.
Risk-Assessment-for-Mint-Flavour-used-instead-of-Mixed-Fruit-Flavour-in-Sildenafil-Citrate-Jelly