We believe that quality is not a destination but a journey. Therefore, we continuously evaluate our quality processes based on internal assessment and client feedback. Our culture of continuous improvement in everything we do, allows us to consistently deliver high quality products, batch after batch, year after year.
Our Total Quality Process cycle is detailed below:
All incoming raw material is tested against pre-defined set of multiple parameters that have evolved and been perfected over the years. These parameters include both internally defined parameters based on 33+ years of learning and Pharmacopoeias’ standards of different countries.
Our incoming material testing is not restricted only to the raw material. All of our packaging material also go through a similar rigor of quality checks, such as dimensions/volume, thickness, weight, food-grade plastic test, etc.
Additionally, we also do a thorough check of the text on the labels, their size, data accuracy, adhesiveness etc., to ensure brand safety.
Once the raw material has passed the incoming material tests, they are accepted for production. In order to ensure final product meets the desired quality specifications, and to avoid any last-minute delivery delay, we perform a series of quality checks at all critical stages of the manufacturing process.
Such tests include but not limited to, content uniformity, particle size, bulk density, moisture content etc.
Before the product is packaged and dispatched, the product goes through a final set of tests. The checks at this stage typically consist of microbiological tests, potency tests, residual solvents etc., and other checks as per client specified parameters.
Every batch of product that we ship, we retain a sample of the shipped product. The retention period of such samples is for a minimum of 1 year from the stated/expected shelf-life. This allows us to determine the probable cause(s) of failure of the product post shipment, if any.
The shelf-life study adheres to ICH guidelines and ensures the product consistently meets the assigned shelf-life parameter.
In an unlikely event that a shipped product has failed to meet the desired quality standards during client’s testing, we conduct a thorough Root Cause Analysis. This root cause analysis is conducted in collaboration with the client to identify and isolate the cause(s) of failure. The findings are shared with the client in a transparent manner. This ensures that appropriate preventive measures are identified and implemented to avoid future occurrences.
Every change in an organization, internal or visible to the client, has a risk associated with it. At Supreem, we take utmost care to analyze risks associated with every major or minor change. We then identify and implement appropriate risk mitigation measures.
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