TABLETS AND CAPSULES MANUFACTURING

TABLET DEPARTMENT

  • Facility includes Granulation, Blending, Compression, Film Coating, Sugar Coating, Enteric Coating, Tablet inspection and Tablets over printing section.
  • All sections provided with 3 micron filtered air and terminally 0.3 micron (HEPA) filters.
  • Temperature and Humidity Maintained as per Product Requirement.
  • Each Cubicle provided with separate AHU.
  • Well Equipped I.P.Q.C. Lab.
  • Quarantine Area for each section.
  • All Section having Required Machinery with GMP Compliance Model.
  • Well Trained Supervisory Staff and Operators.
  • All Process steps Well Documented.

CAPSULE DEPARTMENT

  • Facility includes Blending, Capsulation, Inspection and Sorting.
  • All section provided with 3 micron filter air and terminally 0.3 micron (HEPA) filter.
  • Temperature and humidity monitor & control.
  • Well Equipped I.P.Q.C. Lab.
  • Quarantine Areas.
  • All Sections having GMP compliance machineries.
  • Capsulation section having Semi – Automatic & Automatic Filling, Sorting & Polishing Machines.
  • All Process steps are Well Documented.

PELLETS DEPARTMENT

  • Facility includes Pulveriser, Sifter, Coating Pan, Tray Dryer and Blender.
  • All section provided 3 Micron Filter Air and Terminally 0.3 micron (HEPA) Filter.
  • Temperature and Humidity Monitor & Control (HVAC).
  • Separate Quarantine Area.
  • Entire Section has GMP Compliance Machines.
  • All Process & Steps are Well Documented.

PACKAGING SECTION

  • Primary packing section supplied with 3 micron filter air with terminally 0.3 micron (HEPA) filter.
  • Operation carried out under well controlled environment.
  • Leak testing facility for strips and blisters provided.
  • Secondary packing area having air condition for comfort cooling.Conveyer belts provided for carton filling and shipper pack for each primary packing machine.
  • Line clearance procedure followed strictly before starting new batch or product.
  • Well trained supervisor and operators.
  • Primary section having two blister pack and strip pack machine.

AIR HANDLING SECTION

  • It is kind of GMP model Air Conditioner designed to maintain 24 0C ± 2 0C temperature and desired RH with 3 micron filtration and over 25 air changes. Supply Air Filtered through 10 and 3 micron filter.
  • All Core Process Area are provided with Dedicated AHU and Filtration of 10, 3 and 0.3 Micron Terminal & Hepa filter.
  • Return Air rises with 20µ Filter are provided in Core Area.
  • Ancillary Area, Warehouses are provided with Controlled Environment with 10 and 3 Micron Filtration.
  • Pressure Gradient of 1 to 1 1/2 mm of Water from Room to Room to Passages as the case may be, which is demonstrated on Manometer.
  • Air Handling Systems are validated from time to time.

WAREHOUSE SECTION

  • Equipped to Manage Total Supply Chain. i.e. receipts of RM/PM, Quarantine, Storage and Dispensing.
  • Primary Cleaning by Vacuum on Receipt of Material.
  • Separate Quarantined, On Test and Released Storage Areas.
  • SS Sampling and Dispensing Booth with Reverse Laminar Air Flow system where Man & Material Movement is separate.
  • Locker System for Storage.
  • Quarantined & Released Finish Goods Store.
  • Weighing & staging areas provided.

UTILITIES

Compressed Air
  • Air Compressor from Industry Reputed Manufacturer.
  • On Line Air dryer.
  • 0.1 Micron filtered Compressed Air.
D.G. Set
  • 125 KVA DG set in Case of Power Failure to take case of Critical Operation.
Vacuum Pump
  • Dedicated Vacuum Pump for Capsule Filling Machines and other Operation.
E.T.P.
  • For Primary & Secondary Treatment of Effluents.
Source of Water Supply.
  • Bore Well
  • Source of water supply with R.C.C. storage tanks.
Telecommunication.
  • Each section connected with intercom.

QUALITY MANAGEMENT

Salient features of Quality Control Laboratory.
  • Well Equipped with modern state of the art instrument like HPLC, Spectrophotometer, etc. and Chemical Analysis Section.
  • All the requisite sections include Analytical, Chemical, Instrumentation and Microbiological for complete In-house Testing.
  • Separate Record Room.
  • Well Defined Store for Glassware & Chemicals.
  • Dedicated Microbiology Section having separate AHU equipped with HEPA filtered (0.3 micron) air.
  • Double Air Lock for Microbiology with U.V. in Air Lock & Laminar air flow room.
  • Restricted entry and Double Gowning Procedure in Micro testing room.
  • Conference Room for Quality Control & Quality Assurance Equipped with Audio Visual presentation.
  • Highly Qualified and Experienced Staff.
Validation
  • Water & AHU system validation.
  • Process, Method, Cleaning, Personal and Equipment Validation adhering to GMP standards.
Q. C. Group Responsibilities.
  • To design and approve specifications and test methods for Raw material, packaging material, finished product etc.
  • Calibration of instrument.
  • Need based procedural development.
  • Executing validation.
Q. A. Group Responsibilities.
  • Training for QC, Production, Packing group supervisors and Workman for Non Specific and Generalized Training for GMP, Personal Hygiene etc.
  • Design Validation for Systems, Process and Equipment.
  • Conducting Internal and Vendor Audit.
  • Attend and Resolve any Complaint from Party, Client or Authority.
  • Monitoring CGMP compliance.
  • Documentation & Record Keeping.
  • MFC, Dossier & S.O.P Preparation.
  • Programming Reviewing Stability Studies of Products.
  • Upgrading Manufacturing & Q.C. system.