Accreditation

WHO India PPB Kenya Cambodia GMP Yemen GMP

Interim Accreditation Applied & Inspection Awaiting

Philippines GMP DIGIMED GMP Tanzania GMP Zimbabwe GMP

GLIESSE PHARMACEUTICALS PRIVATE LIMITED
 CONTACT DETAILS
List of Directors
Sr. No. Name of Director Mail ID
1 Mr. Neel Hetal Shah neel@gliessepharma.com
2 Mr. Jatin Shah jatin@gliessepharma.com

List of Key Persons

Sr. No. Name of Director Designation
1 Mr. Sidhivinayak Bobade Manager QA
2 Mr. Sanjay Shah Manager Production
3 Mr. Kalpesh Parmar Manager QC

List of employees department wise

Sr. No. Department Name Number of persons
1 Production 30 + 12 Helper
2 Quality Control 12 + 04 Helper
3 Quality Assurance 05+ 02 Helper
4 Warehouse 03+ 01 Helper
5 Engineering 03+ 03 Helper
6 Human Resource & Admin 03+ 03 Helper
7 Head Office 12+ 04 Helper
GLIESSE PHARMACEUTICALS PRIVATE LIMITED
 Corporate Office & Manufacturing Site

Corporate Office
Office No 205 - Tower-A
Navratna Corporate Park,
Off Bopal Ambli Road,
Ashok Vatika,
Ahmedabad – 380058
Gujarat, India

Manufacturing Site
Survey No. 23/3P & 24, Opp. Jeans
Factory, Daduram Vistar, Village- Bagdol,
Taluka: Kathalal, District: Kheda. Pin:-
387630

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Plant Operations Organogram

Mr. Neel Shah

Mr. Jatin Shah
( Director)

Production Head QA Head & QC Head Officer Warehouse Executive Engineering

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Plant Quality Organogram

Director

Mr. Sidhivinayak Bobade Mr. Kalpesh Parmar

Manager QA Manager-QC

QMS, Analytical RM, PM, In

Validation & Document IPQA Stability Microbiology
Quality process & FP
Qualification Control & Activity Studies testing
Assurance Testing
Training

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Product Profile
● Tablets: (General Category)
 Single layer Tablet
 Bilayer Tablet
 Uncoated Tablet
 Coated Tablet
● Capsules: (General Category)
Filled with various combination as follow,
 Pellets/Pellets
 Pellets/Tablets
 Tablets/Tablets
 Powders/Pellets

● Packing:
 Alu/Alu blister
 Alu/PVC Blister
 Strip Packing
 Bulk packing in HDPE containers.
GLIESSE PHARMACEUTICALS PRIVATE LIMITED
 Site Details

Total Plot Area is about 4588 m².

Build up area is about 3426 m².

Details of Constructed Area of each Section:

GROUND FLOOR
Pharmaceutical manufacturing area and warehouse in ground floor (1241.02 m²).

FIRST FLOOR
Packing material store and Finished goods store in First floor (122 m²).
Quality Control Laboratory in First floor (196 m²).
Microbiology Laboratory in First floor (44 m²).

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Plant Layout Ground Floor

Change Manufacturing Packing

Room Warehouse Area Area
GLIESSE PHARMACEUTICALS PRIVATE LIMITED
 Salient Features of the Facility
• Building is constructed with RCC frame structure. Walls are painted with PU
paints.
• Internal partitions & doors are made by clean room Panels.
• Manufacturing, Packing, warehouse and Quality Control areas have epoxy
flooring and coving at the joints of wall, ceiling and floor.
• Logical flow of men and materials, compatible with the sequence of
processing steps.
• Separate gowning for different areas (Primary and secondary gowning)
• Each core manufacturing area is provided with dedicated AHU.

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Salient Features of the Facility

• Separate storage area for raw material, Solvents, primary and secondary
packaging material and for finished goods.
• Processing areas are provided with seal sanitary type drain.
• De dusting & weight verification for incoming Raw materials and packing
materials.
• Separate dispensing facility for Active and Inactive materials are provided for
raw material
• Dedicated sampling and dispensing facility provided for primary packaging
material.
• Reverse Laminar Air Flow (RLAF) unit is provided for Sampling and
dispensing of raw materials & Primary packing materials .

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Major Production equipment

Equipment Total Number/ Capacity

02 Numbers
Rapid Mixer Granulator
( 150L-1 No’s. & 15L/5L -1 No.)
02 Numbers
Fluid Bed Drier
(60kg-1No. & 5Kg-1No.)
03 Numbers
Bin Blender
(450L-1No., 150L-1No& 15L-1No.)

Ribbon Blender 01 Number (1500 L )

03 Number
Compression Machine (DB Tooling 05 station, B Tooling 35station & D
Tooling 29 station, )
01 Number
Capsule Filling machine
(36000 Caps/ hr)

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Major Production equipment

Equipment Total Number/ Capacity

01 Numbers
Auto Coater
(36 inch -1No.)
01 Numbers
Coating Pan
(18 inch -1No.)

Strip Packing Machine 01 Number

Blister Packing machine 01 Numbers (Alu/Alu)

Blister Packing machine 01 Numbers (Alu/PVC)
01 Numbers (HDPE/ Glass Bottle)
Bottle Packing Machine

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Utilities

EQUIPMENTS TOTAL NUMBER

Air Handling Units (AHU) 18 Numbers

Air Compressors 03 Numbers
Purified Water Plant (PWP) 01 Number
Effluent Treatment Plant (ETP) 01 Number
LAF 01 Number
RLAF 04 Number
Dynamic Pass Box 04 Number
Static Pass Box 14 Number

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Water System
Generation & Distribution of Purified water System :

Purificatio
n by storage Distributio
Carbon passing tank (1K n
Dichlorinat 10-micron capacity)
Chlorinatio filter and Antiscalent through Electro De (Separate
ion of cartridge 1µ filter UV stainless
n of water Dual media treatment double pass ionization UV for
water filteration steel (SS
filter reverse Supply &
osmosis 316L) Return)
system

Purified water Complies with BP Specification.

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

Air Handling System with Air Flow

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Quality Control Laboratory
 Central Quality Control Laboratory.
 Quality Control Laboratory, is equipped to test Raw materials, In-process
materials, Packing Material, Finished Products & Stability Study.
 Laboratory is Divided into Subsection Like:
 Chemical Lab.
 Instrument Lab.
 Microbiology Lab.

 Microbiology Lab.: is capable to perform tests like:

 Microbial Limit Test
 Environment Monitoring by active and passive air sampling
 Water testing
GLIESSE PHARMACEUTICALS PRIVATE LIMITED
 Major Quality Control Instruments

Instrument Make Total Number

HPLC Shimadzu 01
Dissolution Apparatus Electrolab 02
UV/Vis Spectrophotometer Shimadzu 01
Autotitrator Lab India 01

Incubator 400L (20-25o C) 03

Incubator 400L (30-35o C) Kesar
Incubator 227L (40-44o C)
Stability Chamber-8KL (30oC/75%RH),
Stability Chamber-3KL (40oC/75%RH), Kesar 03
Stability Chamber-1KL (30oC/75%RH) Standby

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Key Quality Assurance Activities

– Standard Operating Procedure

– Standard Test specification and method of analysis
– Quality Notification
– Validation
– Self Inspection
– Management Review
– Risk Assessment
– Master Production Records
– Review & Approval of documents
– Final Batch Release
– Shop Floor Activities

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Calibration & Preventive Maintenance

 Calibration
 Laboratory Instruments are calibrated by QC Lab.

 Other measuring instruments are calibrated through authorized

external service agencies.

 Preventive Maintenance
 Manufacturing equipments are covered under PM schedule.

 Critical Laboratory instruments and equipments are covered

through Annual Maintenance Contract with authorized service
agencies.

GLIESSE PHARMACEUTICALS PRIVATE LIMITED

 Work Timings
 The plant runs in following shifts.

 General Shift – 09:00 am till 05:30 pm

GLIESSE PHARMACEUTICALS PRIVATE LIMITED