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