Quality standards

At PURENIC, we firmly believe in building quality into every aspect of our products. We achieve this through meticulous and foolproof proprietary product designs and by operating FDA-compliant facilities. Our commitment is to consistently meet or surpass the quality requirements of our customers as well as the relevant regulatory standards.

To ensure the highest level of quality, we have a dedicated team of experts in Quality and Regulatory Affairs who are actively involved in overseeing and maintaining conformity with both customer specifications and governmental regulations at every stage of our pure nicotine production activities. They work diligently to ensure that our products not only meet the expectations of our customers but also comply with the necessary legal and safety standards.

Continuous improvement is a fundamental part of our quality management approach. We actively seek feedback from our customers, analyze data, and implement necessary changes to enhance our products and processes. By staying abreast of the latest advancements and industry best practices, we continuously refine our quality standards to remain at the forefront of excellence.

Production infrastructure

Our experience in Nicotine since 1976 added to have a full proof design to get consistency high quality products.

Based on product development research in an outsourced research lab and operating on pilot plant, dedicated facility for manufacturing Nicotine and Nicotine salts complying ICH cGMP guidelines was designed.

A world class facility was put in operation since 2009. The salient features are as below:

• In-house design for our process & equipments based on more than 30 years experience.
• Sufficient & adequate infrastructure as per cGMP requirement.
• Dedicated facility for production of Nicotine and Nicotine salts to avoid cross contamination.
• Dedicated areas and utility lines for products to avoid contamination within the facility.
• Own facility for initial extraction of Nicotine from Tobacco thus having full control on supply chain and product quality.
• Huge capacities to meet market requirements.

Quality control

Lab is provided with separate areas for Physico-chemical testing, Instrumentation & Microbiological Testing.

Lab is well equipped for testing of all incoming materials, packaging materials, in process samples, finished products and Stability study samples In-house.

Lab is equipped with all sophisticated instruments such as H.P.L.C.(High Performance Liquid Chromatography) ; G.C.with Headspace (Gas Chromatography) FT-IR (Fourier Transform Infra-Red Spectrophotometer) , UV-VIS Spectrophotometer & Potentiometer Titrator etc.

Highly qualified & experienced employees are employed to monitor the activities.

Documented specifications, procedures & records are in place for activities to be carried out in Q.C in compliance with requirement of ICH(International Conference of Harmonization) guidelines.

All instruments, validation methods are qualified / validated & documented.

Quality assurance

• An independent Quality Assurance section to monitor and assure quality of complete supply chain right from tobacco leaves to final product.
• Our quality measuring/monitoring starts from the Nicotine source tobacco itself, having own Nicotine extraction and purification facility which gives us a high degree of confidence for producing excellent quality products.
• Availability of enough information, knowledge & understanding for the products helped us to design process, equipments & facility assuring quality right from designing of the facility.
• Implementing & updating proper quality systems based on cGMP guidelines at all levels; assures quality of final products.
• Dedicated facility for Nicotine and Nicotine salts manufacturing in operation complying cGMP norms as per ICH (International Conference of Harmonization) guideline.
• WHO-GMP & COFEPRIS approved facility, also having ISO 14001-OHSAS 18001 certification by TUV Nord.
• We hold USDMF and CEP for Nicotine and Nicotine Polacrilex/Nicotine Resinate
• Excellently designed process & facilities as well as sufficient infrastructure to produce Quality Product with all required controls; from procurement, Handling, conversion/production till finished product.
• Dedicated equipments & production lines provided for “No contamination” & “No Compromise” in product Quality.
• The manufacturing equipments/process qualified / validated & documented.
• Finished product meeting very well USP/EP requirements.
• Highly qualified & experienced employees are employed to monitor the activities.

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