The product has undergone comprehensive process validation in accordance with the established Process Validation Protocol to develop a standardized manufacturing process and ensure that every batch consistently meets the required standards for quality, safety, and consistency. Three critical manufacturing processes are controlled throughout production: Blending, Tablet, Compression.
Bottle Filling In-Process Control (IPC) is conducted throughout manufacturing to monitor key quality attributes, including tablet appearance, weight, hardness, disintegration, and tablet count. During tablet compression, samples are collected every 30 minutes to evaluate tablet weight, hardness, and count, allowing real-time verification of process stability and minimizing batch-to-batch variation. Upon completion of manufacturing, each batch undergoes final quality testing according to the established product specifications, including appearance, identification (HPLC), disintegration time, weight variation, and assay of the active ingredient. Product specifications include: off-white to pale yellow tablets; disintegration within 30 minutes; weight variation within specification; and Fluralaner content between 90% and 110% of the labeled claim.
Through comprehensive process validation, continuous process monitoring, and rigorous finished product testing, the product consistently demonstrates excellent batch-to-batch quality and stability, providing a safe and reliable product for users.
From raw material acceptance and manufacturing to finished product release, all operations follow standard operating procedures (SOPs) and quality management regulations to ensure product consistency and safety. All raw materials and packaging materials undergo quality testing according to their respective specifications, including appearance, identification, and relevant quality indicators.
Only released for production after compliance is confirmed, ensuring the stability and reliability of the materials used. Upon completion of manufacturing, a full quality inspection is conducted based on finished product standards, covering appearance, identification, disintegration time, weight variation, and active ingredient content.
Shipment is authorized only after all test results are confirmed to comply with product specifications, ensuring that every batch meets quality requirements. Furthermore, to continuously monitor quality stability throughout the shelf life, stability testing is performed annually on the first batch of the year.
This regularly tracks quality changes during storage to confirm that the product maintains its designated quality, safety, and efficacy within its expiration period. Through raw material management, in-process quality control, finished product testing, and stability monitoring, this product has built a complete quality assurance mechanism, ensuring excellent batch-to-batch consistency and providing consumers with safe, reliable and trustworthy products.
This product has established a comprehensive risk management mechanism. Controls are implemented in accordance with the quality management system across all stages—from raw material receiving, manufacturing, and finished product release to post-marketing quality monitoring—to ensure product quality, safety, and consistency.
Incoming Material Risk Control Upon arrival, all raw materials and packaging materials must undergo quality inspection according to their respective material specifications and can only be released for use after confirming compliance. For raw materials subject to shelf-life management, a re-test is performed every two years as required, to reducing the risk of variations in raw material quality.
Manufacturing Process Risk Control The manufacturing process is executed based on standard operating procedures and process validation. An In-Process Control (IPC) mechanism is established to monitor critical processes, including blending, tableting, and packaging.
Finished Product Risk Control Upon completion of manufacturing, a full quality inspection is performed according to finished product testing specifications, including appearance, identification, weight variation, disintegration time, and active ingredient content. All test results must meet product specifications before the batch can be released for shipment, ensuring that every batch complies with established quality requirements.
Product Traceability and Logistics Management
We have implemented a Warehouse Management System (WMS) to manage product inventory, batch numbers, shipping and distribution data. A good batch traceability mechanism is established to ensure clear tracking of product flow, thereby improving logistics efficiency and quality management capabilities. 2. Product Recall Management The company has established a standard operating procedure for product recalls and conducts annual mock recall exercises.
This validates the integrity and execution efficiency of the product tracking, notification, and recall processes, ensuring that swift and appropriate actions can be taken in the event of quality anomalies to minimize the impact.
Post-Marketing Quality Monitoring The company maintains a well-defined customer complaint acceptance and handling mechanism. Quality-related feedback from customers is investigated, analyzed for root causes, corrected, and tracked in accordance with standard procedures. Sales also regularly visit collaborating veterinarians to proactively gather user experience, feedback and market information.
Continuous Improvement Mechanism The company periodically compiles post-marketing monitoring data—including customer complaint records, veterinarian feedback, mock recall results, and quality monitoring data—as vital inputs for quality management and risk assessment. If necessary, corrective actions are initiated to optimize product quality and management processes.
