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GMP Manufacturing

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VerGo Pharma has state of an art UK-MHRA, EU-SUKL, TGA and WHO approved manufacturing units to provide a seamless approach through all phases of development and ultimately to commercialization. From simplified dosage forms in the earliest clinical pilot, Bio batches to critical registration/submission and commercial batches are being manufactured at VerGo.

Warehouse

State of the art Warehouse facility having dedicated area for storage of Raw and Packaging Material. Storage of Raw Material and Packaging Materials is done at designated areas like Under Test and Approved Material. First in first out system is used for dispensing of material. Spacious finished goods store is maintained under controlled temperature with adequate security and tracking system.

  • Dedicated areas for storage of Raw materials, packing material and Finished goods as per their quality status (Quarantined, Under Test, Approved and Rejection).
  • Warehouse area facilitated with Cold storage room (5000ltrs capacity) to store Raw materials with required storage condition between 2℃ -8℃.
  • Separate dedicated area for storage of Flammable Solvent (Ex. IPA, Ethanol, Methanol, Acetone etc.).
  • Warehouse facilitated with dedicated area for receiving and dispatch bay for incoming and outgoing materials.
  • Separate dedicated area for sampling and dispensing of raw materials to manufacturing department.
  • Temperature maintained in warehouse between 15℃ -25℃ and Relative humidity between 45% to 65% through HVAC system 24X7.
  • Monitoring of temperature and Relative humidity in done through Honeywell Data logger system, facilitated with alarm system in case of excursion in the environmental condition..
  • Daily activities in the warehouse are handled and managed by well experienced and trained personnel.
  • Tie-up with reputed logistic companies for the transportation of incoming and outgoing materials.

Manufacturing

VerGo Pharma has state of an art UK-MHRA, EU-SUKL, TGA and WHO approved manufacturing units to provide a seamless approach through all phases of development and ultimately to commercialization. From simplified dosage forms in the earliest clinical pilot, Bio batches to critical registration/submission and commercial batches are being manufactured at VerGo.

Highlights:
  • Year 2016-Started commercial production, first product manufactured was Colchicine tablets followed by Liothyronine.
  • Year 2018-New Blister Pack machine installed with higher capacity.
  • Site transfer product validation batches initiated in year 2018.
  • New Track N Trace machine installed to comply with EUFMD Guidelines on Export shipments.
  • Year 2019-Addition of new granulation suite done to increase the capacity with addition of RMG (250lts) and FBD (100kg).
  • Year 2020-New Coating Machine installed and used for commercial batches.
  • Year 2021-second Blister machine installed to increase the manufacturing capacity from 200 mio to 400 mio.
  • Year 2022- Additional TNT machine installed to support second blister packing machine.
  • Year 2022- In Q3 we crossed 100 Mio volume and later in Q4 we achieved > 150 Mio Volume.

Quality Control

VerGo Pharma Research has fully established Quality Control facility to meet the ever rising demands of the global healthcare industry. Experienced Analyst and advanced capabilities lead to fast and scientifically sound results. We support testing of Raw materials, packaging materials and drug products like tablets, capsule and all intermediate stage samples like blend, compressed tablets, filled capsule, coated tablets etc. We have also well-established stability testing facility to meet requirements of all climatic conditions.

Quality Control Services:
  • Raw materials sampling and testing
  • Packaging materials sampling and testing
  • In-process samples testing (Blend, Tablets, Capsule, granules etc)
  • Finished product testing
  • Stability management and testing
  • Analytical method validation, verification and transfer
  • Residue method development and validations
  • API method verification
Quality Control Services:
  • 21 HPLC/UHPLC (Waters, Agilent, Shimadzu)
  • GC – Agilent, Shimadzu FID with Head Space
  • Dissolution Type I, II (Electrolab, Sotax)
  • AAS Shimadzu flame model, Lamp – Na, K, Mg, Cd, Cu, Mn, Fe, Ca, Sr
  • UV (Shimadzu)
  • IR (Shimadzu)
  • KF (Metrohm)

Microbiology

VerGo pharma has well equipped microbiology laboratory. We have Qualified equipments such as Horizontal Autoclave, BOD Incubators & Laminar air flow units. We support R & D department and GMP department with respect to microtrial limit testing and environmental monitoring activities.

Microbiology Capabilities:
  • Microbial Limit test
  • Antimicrobial Efficacy test
  • Environmental Monitoring by settle plate, Air sampling, Finger Dab, Contact plate Area and equipment & swab analysis.
  • Water microbial analysis
  • Bacterial endotoxin test
  • Antibiotics and vitamins assays
  • Raw materials/excipients analysis as per Pharmacopeia's
  • Finished product & stability testing
  • Disinfectant effectiveness Testing
  • Cleaning validation microbial analysis
  • Packing material microbial analysis
  • Microbial method validation for API & Finished product

Stability studies

VerGo Pharma provides stability study services as per ICH and GLP requirements for all four zones. We have 1,15875 L of storage space with walk-in and reach-in stability chambers including refrigerated and freeze thaw conditions as well as photo stability. Chambers are individually monitored 24/7 by “YOKOGAWA DAQSTATION DX2000 Recorder” which complies to US FDA 21 CFR Part11 with back-up units. We provide stability testing to support your regulatory submissions, and ensure accurate evaluation of quality, strength, purity, potency and identity of the products.

Stability Services:
  • Protocol design.
  • Retention, logging and tracking.
  • Stability testing of samples.
  • Data trending.
  • Expiration dating.
  • Forced degradation studies.
  • Comprehensive stability report.
  • In-use study.
  • Stress testing.
Infrastructure & Capabilities:
  • 25°C with 60% RH.
  • 40°C with 75% RH.
  • 30°C with 65% and 75% RH [Zone IV A and IV B].
  • 30°C with 35% RH.
  • -18°C, 50°C, 50°C with 75% RH [Stress Testing].
  • Photo stability cum humidity.
  • Semi-permeable container testing.
Salient feature:
  • The Yokogawa DAQSTANDARD application software is the standard accessory PC software package for the DAQSTATION DX2000, paperless recorders. It allows data acquired with the DX recorders to be viewed along with associated audit trail information.
  • Universal sensors with CFR 11 compliant software data integrity.
  • Back-up for condensing units, boiler heaters and power for un-interrupted functioning of stability chambers.
  • Safety device are available for overshoot temperature.
  • PLC Mechanism to regulate/monitor temperature and humidity.
  • Support to import clearance/logistics of test samples.
  • Standalone state of the art analytical laboratory and QC to support development and testing.
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Quality Assurance

VerGo has reliable “Quality” objectives that are comprehensively designed and have correctly implemented system of “Quality assurance” incorporating “Good Manufacturing practices” and “Quality Control System”.

SALIENT FEATURES
  • Establish Standards Quality Assurance procedures.
  • Implementation of Quality Management System.
  • Conduct Product Review.
  • Create report on project status.
  • Perform Process Compliance Review.
  • Identify Process Improvement Area.
  • Safety Policy.
  • Environmental Policy.
  • To be in-par to Local & Global Regulatory requirements.
  • To maintain Data Integrity.
  • Ensure Right Quality Resources to achieve Quality.
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Engineering

VerGo pharma has a branch of Engineering focused on maintaining and improving the site.

Engineering Services:
  • Utilities
  • Maintenance
  • Project works
Equipment Capabilities:
  • HVAC
  • Purified Water System
  • Effluent Treatment Plant
  • Air Compressor
  • Chiller
  • Backup Power Supply