Infrastructure

The plant site located at Ankleshwar GIDC's industrial cluster is well supported by our commercial ofces and Research centre located at Baroda in the state of Gujarat.

The Ankleshwar plant is spread over an area of 10,000 m2 and includes warehouses, two synthesis blocks, QC/QA laboratories, utility block, effluent treatment plant and administrative offices.

The site, periodically inspected by our customers and authorities, meets all the required quality and environment standards. Over the years we have systematically invested in human and capital resources. This has been a key success factor and enabled us to develop and build infrastructure as per cGMP and FDA requirements.

Manufacturing

At SPC Lifesciences our knowledge is backed up by state-of- the-art technology, Supply chain & manufacturing. That is how we ensure that our comprehensive product solutions are matched by our ability to deliver across every complex project.

Spread across an area of 10,000 m2, SPC operates three multi-purpose manufacturing plants for Basic Intermediates, Advanced Intermediates & Strategic Products respectively at Ankleshwar.

Backed by SPC’s technical knowhow & manufacturing support, partnerships with 5 other manufacturing facilities ensure a smooth flow of basic intermediates feeded to our main plant.

Our onsite processing capacity of 180 KL equipped with five finishing areas for solid & liquid handling along with warehousing and effluent treatment facilities ensure multi-product management with regulatory compliance for intermediates of various scale from 1 MT to 50 MT per month.

Equipments
Equipments Nos.Capacity
• Glass Lined Reactors
17
1 m3  - 6.3 m3
• Stainless Steel Reactors 17 1.2 m3  - 7.5 m3
Distillation Setups
Distillation Setups Nos.Capacity
• Fractional Distillation Reactor Units with packed columns
6
0.5 m3  - 4.0 m3
• Solvent Recovery Reactor Units with packed columns 1 7.5 m3
Utilities
Utilities Nos.Capacity
• Boilers
2
1 - 2.5 T/hr
• Chilling Plant (-20oC) 1 30 TR
• Cooling Towers 4 100 - 500 TR
• Hot oil circulation unit 1 100000 kW
• Multistage High Vacuum Ejectors 4 759 mm
Warehouse
Warehouse Nos.Capacity
• Integrated warehouses with racking systems 2
1200 m3
     
Quality & Compliance

The only reason our clients like to work with us, is because we ensure that our quality works for them. That is why every step of our process is underlined by our promise to deliver high- performance solutions.

We are committed to comprehensive reviews of quality compliance to ensure a singular quality process that is continually assessed and refined. Using high quality chemicals our intermediates & APIs are manufactured to ensure desired efficacy and our ONE QUALITY CONCEPT keeps pushing the quality standard higher and setting new benchmarks.

We adhere to ISO 9001 and ISO 14001 standards controlled by 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.

Regulatory Affairs

SPC understands the requirements of its customers and supports them in compilation of regulatory filing by providing chemistry, manufacturing and control documentations, analytical documents, impurity profiles, change controls and stability documents. SPC respects the Intellectual property of its customers and a CDA may be required prior to sharing confidential details necessary for regulatory purpose.

Quality System and Regulatory Affairs
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. Handling of Deviation, Change control, OOS, Customer Complaints. Training Evaluation & Induction Training
RA
Regulatory compliance Technical Package Customer Satisfaction Declaration to customer Quality Agreement. DMF preparation. Vendor Questionnaire
Quality Control

The quality control department is sufficiently equipped with the most experienced personnel and is supported by the latest instruments and equipment to manage the stringent standards applied to release of raw materials, in-process intermediates and final products.

GC: 4 Nos. HPLC: 2 Nos. UV: 1 Nos.
     
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