Quality Policy

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Quality Management :

Smaart adheres to highest standards of Quality, and we put our best foot forward to stain at every level by strict compliance to GLP ( Good Laboratory Practices). our manufacturing facility is state-of-the-art with all quality systems and processes which enables us to comply with cGMP. We aim at achieving world-class Quality standards for all our products. To accomplish this we deploy rigorous testing and elaborate in-process control procedures backed by Robust Quality Management system with Core Standard Operating Procedures detailed across the company ensure the best quality products.

Quality Control Systems :

Quality control labs equipped with high-precision instruments ensures; excellence is maintained consistently across all the production processes. All receivable and input materials that goes into production are evaluated as per the standard specifications. The complete thorough analysis & certification of materials, intermediates & finished product is done.

Calibration program for all analytical instruments and stability program for finished products gives assurance that the product which leaves our plants are of highest quality standards.

Quality Assurance Systems :

Quality Assurance Department has an excellent team of professionals having good understanding of concepts of quality systems and cGMP. A Quality manual governing all cGMP related activities with Standard Operating Procedures detailed for all activities has been developed. Quality Assurance review of product documentation along with annual product quality review, support to DMF fillings, through investigation of any process deviation makes us a partner of choice for our customers.

Analytical Development & Validation Services :

At the same time as the development process is underway; Smaart Pharma will develop analytical HPLC/UPLC methods and validation tools. These tools will monitor the process for any unwanted reactions, required purity standards, and limit any residual impurities in the product, controlling the final API to ensure the required quality attributes.

Peptide Quality & Systems :

Smaart Pharma, has developed a unique model that allows us to manufacture the highest quality peptides at the lowest possible prices for pharmaceutical organizations and We maintain the highest standards for quality and compliance. We meet or exceed all FDA standards for manufacturing.

GMP Manufacturing :

The professionals at Smaart Pharma have more than 90 years of cumulative experience in process development, scale up, and cGMP (Current Good Manufacturing Practice standards as defined by the FDA).
With fully-controlled cGMP systems, rigorous quality system(GLP), and experienced management, we can provide the lowest cost of manufacturing with solution phase, solid phase or hybrid peptide synthesis.

Quality & Compliance :

Smaart Pharma maintains the highest level of quality and compliance in its plants, we provide rigid quality controls, standard operating procedures (SOPs), training, and rigorous testing.
Experienced Quality Assurance staff and professionals review operations on a consistent basis.