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.
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.
Primary section having three blister pack and strip pack machine.
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.
ALU/ALU blister 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.
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.
Locker System for Storage.
SS Sampling and Dispensing Booth with Reverse Laminar Air Flow system where Man Material Movement is separate.
Quarantined Released Finish Goods Store.
Weighing staging areas provided.
Air Compressor from Industry Reputed Manufacturer.
On Line Air dryer.
0.1 Micron filtered Compressed Air.
125 KVA DG set in Case of Power Failure to take case of Critical Operation.
Dedicated Vacuum Pump for Capsule Filling Machines and other Operation.
For Primary & Secondary Treatment of Effluents.
Source of Water Supply
Source of water supply with R.C.C. storage tanks.
Each section connected with intercom.
Salient features of Quality Control Laboratory
Well Equipped with modern state of the art instrument like HPLC, Spectrophotometer, FTIR etc. and Chemical Analysis Section.
All the requisite sections include Analytical, Chemical, Instrumentation and Microbiological forcomplete 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.
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.
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.