7. The company is situated at A-2-44,45 Sector- 15 GIDA Industrial
Area Gorakhpur-273209 (U.P.)
We have a well furnished office with all
necessary facilities.
16. RM STORES
In RM Store we have following Segregated area:-
Dedusting Area: In this area dedusting of the received
material is done by Vacuum cleaner
Sampling Area : Sampling area has RLAF booth under
which sampling is done. The surrounding area is
supported by AHU for this booth we have different
entries for material and Men. SOP displayed.
Dispensing Area : This area is also equipped with RLAF
for dispensing the RM. Background of RLF is supported
by AHU. For this area also we have different entries per
material and men along with the equipment washing
area.
33. Filling and Sealing Area Glass Bottles
Floor, Coving and Epoxy coated. It is controlled by HEPA filter and AHU
having the cooling system. Contamination is controlled by pressure
differentiation in the area.
36. Filling of P.P. Bottles
Floor, Coving and Epoxy coated. It is controlled by HEPA filter
and AHU having the cooling system. Contamination is
controlled by pressure differentiation in the area, activities
carried out under LAF.
42. Quality Control
Microbiological Testing area
Hot Zone area : Incubetor, Stability Chamber etc
Documentations :-
Calibration record
Stability records
Trend analysis report
SOP
Microbiological monitoring
58. Quality Assurance
Quality assurance deptt is responsible for in process
control at all critical stages of manufacturing. QA
Department is also responsible for release of finished
batch for distribution, control of documents
59. Self Inspection System
The company has a well-defined Self-Inspection
system through which all manufacturing functions.
Engineering Department, Quality Control
Department and Warehouse are audited by a team of
representative designated by Technical Director. The
Team shall comprise of personnel from Production,
Quality Control , Quality Assurance & Engineering /
Maintenance Department. The team shall observe &
check all processes, documents during self
inspection programme
60. Self Inspection System
Personnel
Premises including personnel facilities.
Maintenance of building & equipments.
Storage of starting material & finished products.
Equipments .
Production & In -process controls
Quality control
Documentation
Sanitation & Hygiene.
Validation & revalidation programme.
Calibration of instruments or measurement system.
Recall Procedure.
Complaint Management.
Labels Controls.
Results of previous self inspection & any corrective steps taken.
61. Self Inspection System
The audit report includes the observations,
recommendations for the improvement and follow up
actions required. The audit report is submitted to the
Technical Director and major action plans are discussed.
Such inspection reports are for internal purpose and are
not shared with any other agency.
67. Water System
Comprises of R.O. Plant, D.M. Water Plant and Multi-column
Distillation units. Water Purification is done by DM Water Plant,
D.M. water stored in SS tank, and WFI from Multi-column
Distillation units are separately supplied to formulation area
through UV lights in loop line system.
75. HVAC SystemSeparate air handling system is provided to eliminate any
possible potential of Cross contamination from one processing
area to another. Each critical process operation has its own air
handling system, with HEPA filter temperature and humidity
control, there are 15 AHUs installed .