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Quality Control and Quality Assurance

As manufacturers of LVP products that are used to treat the critically ill, we shoulder a huge responsibility. At Inven, we believe that Quality Control and Quality Assuranceare the key to a product that is safe and performs its intended role. This, precisely, is why we believe the onus is on us to deliver quality products without seeking to merely meet regulatory requirements.

Quality at Every Step

Building quality into our products is something we take very seriously and therefore, we pay a lot of attention to the materials and equipment we use, the processes we design, the procedures our personnel follow and the testing protocols we use. At every step of the manufacturing process, we seek to understand the causes of any variability that may be observed and work committedly towards eliminating it. Our Quality Control lab is well-equipped with instruments required for exhaustive analysis of raw materials, in-process samples as well as finished products. We have strict protocols in place for approving product batches following successful testing as well as dealing with out of specifications results.

Compliance with Regulatory Requirements

Traditionally, the pharmaceutical industry has always been a tightly regulated one with the regulators laying down stringent guidelines to ensure product quality. However, in recent times, regulators across the globe – with the USFDA notably in the lead – have sought to create an environment where pharmaceutical manufacturers develop an efficient system that reliably produces quality products. At Inven, we take this responsibility very seriously and even as we make sure we comply with regulatory requirements, we also strive for constant improvement.

Our Commitment to Quality

Inven ensures quality of its products by a careful control of the critical parameters that play an important role during the manufacture of LVP products. All the raw materials we use are sourced from vendors that have been certified by our Quality Assurance team following a stringent quality audit. This ensures we have a consistent supply of starting materials that meet our quality specifications, and this gives us the confidence to manufacture top-quality products. Our processes, equipment, cleaning procedures and analytical testing methods are all validated on a regular basis to enable us to consistently produce products of reliable quality. All our personnel undergo regular and relevant training to ensure they perform their tasks in a way that ensures quality is built into our products. Our Quality Control team has developed in-house specifications that allow us to deliver products that meet standards more exacting than regulatory requirements.

At Inven, we are continually focused on the need to design and adopt systems, processes and procedures that are robust and sustainable even as they are simple. Our Quality Assurance program – which is independent of the production and quality control teams – serves to