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The SPC Edge

Home The SPC Edge

Infrastructure

  • Our Plant is located in the heart of GIDC's Industrial Cluster in Ankleshwar, Gujarat. It is supported by & works simultaneously with our commercial office, research, and development center located in the city of Vadodara Gujarat.

  • Our plant site at Ankleshwar spreads over an area of 10,000 m sq including warehouses, synthesis blocks, QC/QA laboratories, utility blocks, effluent treatment plants, and administrative offices. A routine inspection at our site is a common occurrence by our customers or designated authorities.

  • The Ankleshwar plant maintains all required quality and environmental standards and keeps improving them on continous basis. Over the years we have invested in human and capital resources enabling our success, development & growth. We have built an infrastructure to meet cGMP and FDA requirements.

Manufacturing

  • SPC Lifesciences is a result of our knowledge, backed by state-of-the-art technology, supply chain, & manufacturing capabilities. It is a way to ensure our comprehensive product solutions match the ability to deliver across every complex project.

  • SPC operates four manufacturing blocks for basic intermediates, advanced intermediates, and strategic products respectively at Ankleshwar. Backed by SPC’s technical team and manufacturing services, this site has a processing capacity of 180 KL equipped with five finishing areas for both solid and liquid handling along with warehouse and effluent treatment facilities to ensure multi-product management with regulatory compliance for intermediate of various scales ranging from 1MT to 50 MT per month.

Quality & Complainces

  • The key reason for our client's unyielding trust is our top-shelf quality & efficient delivery according to the desired demands and requirements hence every step of our process is underlined by our promise to deliver operational excellence to build quality to specification.

  • We are committed to quality compliance to ensure a singular quality process that is constantly assessed and refined by our team of experts. Using high-quality chemicals our intermediates and APIs are manufactured to ensure desired efficiency and our ONE QUALITY CONCEPT keeps pushing quality standards even higher while setting new benchmarks.

  • We adhere to ISO 9001 and ISO 14001, GMP standards controlled by the Quality Assurance Group. Documentation on cGMP guidelines right from raw material receipt, manufacturing to finished products & services.

  • Further control is established by adherence to cGMP guidelines where all activities starting from receipt of raw materials to dispatch of final products including training, safety, and maintenance are documented and controlled.
ADL

Method development Method Transfer R&D Product Testing & Releasing HPLC / GC Techniques Impurity Isolation Establishment of Reference Standard. Preparation of Specification and MOA.

QC

Sampling, Testing and Releasing Calibration of instruments. Chromatographic Techniques Wet Chemical Techniques Impurity Tracking Method validation Specification Development. Preparation of Specification and MOA GLP implementation Hold time study Testing Preparation of working standard.

QA

IPQA observation. Batch Release & Issuance of Control Record Technology Transfer, Documentation & Approval SOP preparation and compliance, Document Distribution & Control Product Quality Review and Trend Analysis. Process Validation Audit Preparation and hosting ISO/GMP Implementation.

RA

Regulatory compliance Technical Package Customer Satisfaction Declaration to customer Quality Agreement. DMF preparation. Vendor Questionnaire

ENSURING SUSTAINABILITY AT ALL LEVELS

SPC Lifesciences is always committed to and complies with the core definition of Sustainability that is to “create and maintain the conditions under which humanity and nature can exist in productive harmony that permits fulfilling the social, economic and other requirements of the present and future generations”.

  • OUR PEOPLE – DIVERSITY – DIGNITY

    Our people are our biggest assets and they make us what we are. Experts and trained professionals of different specialisations unite as one family with cohesive teamwork, defining and differentiating us in the marketplace.

  • ECO FRIENDLY

    Upgrading of technologies and infrastructure for effective reuse and recycling, prevention of energy losses and reducing harmful impact(s) on our natural surroundings.

  • PRODUCTS - COMMITMENT

    Continual and remarkable improvement in product development and in each stage of the operations to facilitate better efficiency and higher customer satisfaction.

  • ENTREPRENEURSHIP – SUCCESS – SOCIETY

    Taking ownership and responsibility of what we do for the success of the organization and well-being of the society in general.