We have multi-level of Quality Assurance at each Step of Business Process.

Quality Policy

To develop quality, safe and efficacious Pharmaceutical Standards, Drug Materials, Drug Products, Developing Technologies in Formulation Research & Chemical Research, giving Quality Analytical Testing services by continuous monitoring of quality systems. Uphold to strict quality principles and meeting customer’s expectations by involving all the Employees of the Organization.

To maintain quality system as per the requirements of the International Standard ISO/IEC 17025:2005 relevant NABL Certification, ISO 9001:2015, ISO 17034:2016, ISO 14001:2015, OHSAS 18001:2007, GLP Certificate and DSIR Certification.

Quality Management System

We at SimSon have a full Quality Management System to control the Quality from concept to Commercialization.

Quality planning: At SimSon, quality is part of each and every step. Planning focuses on all areas of operation comprising procurement of the raw materials, to synthesis, then Storage and precise delivery as per customer's requirements.

Quality assurance: SimSon’s Quality Assurance Department, constantly monitors and appraises the service as per SOP’s to ensure requirements for Quality are being satisfied.

Quality control: SimSon embraces, a full-fledged Quality Control Laboratory, which follows and integrates up-to-date, contemporary, and high-tech testing equipment, in order to perform the stringent quality analytical tests like HPLC/GC, Mass Spectroscopy, IR Spectroscopy, Thermal Gravimetric Analysis (TGA).

Quality improvement: SimSon is dedicated and committed to delivering value and satisfaction by improving and maintaining the Quality Management System through meeting specific needs, training to an individual, CAPA, Clean Work Environment.

Document Control: At SimSon, Document and Data are maintained to control all documents that form part of its management system, internally generated or from external sources, including SOP’s with master and Controlled Copy, Test and Calibration Records, Soft copy of Data on Server.

Audit Management: SimSon conducts periodic self-assessments through a voluntary self-audit of its operations, in order to remain internationally competitive, and maintaining an effective Quality Management System.

CAPA Management: At SimSon, we Follow CAPA management for any Discrepancies and Audit Findings. It assures the tracking and trending of issues requiring mid-term and long-term corrective actions.

Training Control: SimSon has an effective training Execution from Induction to SOP and Practical training to Presentations, so that the entrant is fully aware of well-being at SimSon.

Quality and Purity Assessment

At SimSon, we Qualify the Synthesized compounds for Identification / structure elucidation and Qualification by HNMR and 13C-NMR, MASS, IR Spectroscopy, CHNS and Purity by HPLC/GC/Chemical Analysis. Purity/Potency is defined by Mass Balance Method using Chromatographic purity and TGA Data, For Volatile Compounds Ash Content is performed.

After Qualification, product is sent into Global Warehouse.  Inventory Team Checks the product for Quality, from Description to all Characterized Data and approves the qualification Report with interpretation of all Data.

Once the Material is Qualified and Approved, it is taken into Approved Area and made available for Dispatching.

Before Dispatch, the material is again Reviewed and Checked by Dispatch QA. Once the Dispatch QA approves the Quality and Documents as per Specification, it is ready to Dispatch.

Packaging

At SimSon, we follow 3-layered packaging System:

  • For Primary Packing of All CRS, we use high Quality Glass Vials or Storage Vials. For hygroscopic and sensitive products, the vials are purged with Nitrogen or Argon.
  • These Vials are packed in a Secondary Protective HDPE Bottle.
  • These Vials are packed in Thermocol Boxes.
  • The Thermocol Box is packed in a strong protective outer carton.
  • Special Packing and Special Shipping at -20°C can be done for highly sensitive materials.

Our Certification for Quality

  • GLP Certificate

  • DSIR Recognition

  • ISO 9001:2015

  • ISO 14001:2015

  • ISO 17034:2016

  • ISO / IEC 17025

  • OHSAS 18001:2007

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