Trouble Shooting Services
Trouble Shooting Services
We involve in Identifying and resolving issues that arise during various stages of drug development, manufacturing, quality control, and distribution. Effective troubleshooting in pharma is crucial for ensuring product quality, compliance, and patient safety.
FDA encourages continuous manufacturing methods
The FDA is also encouraging pharma companies to switch over to continuous manufacturing (CM), where raw materials pass through a continuous, uninterrupted manufacturing chain right up to the finished product. The FDA claims that CM improves product quality and helps to reduce shortages in medicine. It also enhances efficiency in manufacturing, to the point that a drug that might take a month to produce in batch processing can take as little as one day using a CM setup.
However, without rigorous testing of individual batches, it is necessary to have continuous quality monitoring and control to ensure that the pharmaceutical products maintain their safety and efficacy. This requires sophisticated second-level control systems to monitor the system to ensure that quality and safety are maintained and to promptly issue alarms in the case of any deviations.
Alternate vendor sourcing for Raw Materials (API & Excipients)
Negotiate with suppliers: Getting better prices from suppliers can reduce expenses and improve profitability.
Consider changing suppliers: While there are risks, this can be a proven way to reduce costs. When choosing a new supplier, ensure they provide consistent quality, adequate service, and safety nets against price increases.
Process optimizations, product collaborations and yield improvisations
Process optimization and scale-up are critical stages in pharmaceutical manufacturing that ensure consistency, reliability, and efficiency of the product. By optimizing the manufacturing process, manufacturers can identify and resolve potential bottlenecks, reduce variability, and increase productivity while ensuring safety, efficacy, and quality of the product.
Scale-up involves transferring the optimized process from the lab or pilot plant to the manufacturing plant while maintaining the same level of quality, safety, and efficacy. This ensures that the product can be produced in large quantities to meet the demand of patients while still meeting regulatory requirements.
Manufacturers can use several strategies such as process mapping, risk assessment, and statistical process control to ensure a successful scale-up.
