ARIES DRUGS PRIVATE LIMITED

Plot no. 90
Sector-IIDC, Sidcul,
Pant Nagar- 263 145,
UTTARAKHAND,
E-mail : [email protected]
Website : www.ariesdrugs.com

SITE MASTER FILE

COMPANY’S RESPONSIBLE PERSON

NAME DESIGNATION

MR. HARIOM AGARWAL CHAIRMAN

MR. AMIT AGARWAL MANAGING DIRECTOR/ PLANT HEAD

MR. ROBIN MATHEW DIRECTOR

Mrs. MUKUL AGARWAL DIRECTOR

Mr. SUSHANT RAI AGARWAL H.R & ADMINISTRATION.
MR. ASHOK JAISWAL PRODUCTION IN-CHARGE
MR. KAILASH DASS QC IN-CHARGE
MR. ANOOP DUTTA STORE IN-CHARGE
 ARIES DRUGS PRIVATE LIMITED
CONTENTS
1. GENERAL INFORMATION
2. SPECIFIC INFORMATION
3. PREMISES, FACILITIES AND EQUIPMENTS
4. DOCUMENTATION
5. PRODUCTION
6. QUALITY CONTROL
7. CONTRACT MANUFECTURER & LICENSEE
8. DISTRIBUTION, COMPLAINTS, & PRODUCT RECALLS
9. SELF- INSPECTION
10. FLOW CHARTS - PRODUCTION DEPARTMENT:

Material Movements & Oral Liquid Production
11. FLOW CHARTS - QUALITY CONTROL DEPARTMENT:

Sterility testing Packaging Material Analysis & Release

In-process QA/QC & Finished Product Analysis

Raw Material Analysis & Release
12. LIST OF PRODUCTS
13. SOP INDICES

Quality Control

Production

Stores

Administration

Store Department

Water System
14. PRODUCTION MACHINERY
15. QUALITY CONTROL EQUIPMENTS
16. ORGANIZATION CHART:

Company Organ gram
17. FLOW CHARTS: Engineering

Store Management System

Water System

Preventive Maintenance Schedule
18. MANPOWER STRENGTH
1.0 GENERAL INFORMATION
1.1 Brief information of the Company
Aries drugs Pvt. Ltd. Was established in 2005 on the 4th day of April at LUCKNOW with five Directors.
The company was established with 22 Medical representatives and five managers for its own marketing
in Uttar Pradesh state. Aries started with the complete B2 range of products including Tablets, Capsules
& Oral Liquids for its marketing; earlier the products were getting manufactured from Himachal &
Haryana State under strict quality parameters.
The vision of the company was to establish its own manufacturing unit within next four to five years.
Therefore in this regard the company purchased the land for the manufacturing unit in Uttarakhand
Integrated Industrial Estate at Pantnagar, Rudrapur.
Aries now has established its own manufacturing unit specializing in Oral Liquid Plant only.

This manufacturing facility has been designed with modern, automated processes, utilities and
equipments conforming to national standards and cGMP norms amended from time to time. Facility has
the capacity to produce complete Oral Liquid Unit. Using modern equipments, This manufacturing
facility is national regulatory compliant and is futuristically designed. In our company has fully
automatic equipments/Instruments for manufacturing. In all department supply fresh air & AHU with
0.5µ filter.
1.2 Manufacture of pharmaceutical products
The facility is dedicated for production of Antibiotics, Multivitamins, Cough Syrup, and
Antialargic. All the above products are manufactured in the following dosage forms in Oral
Liquid :
Manufacturing License No. 17/UA/2009 IN FORM No. 25 and Manufacturing License No.
19/UA/SC/P-2009 in Form No. 28 are issued by Uttarakhand Drug Licensing Authority.
1.3 Our Contact details:
a) Manufacturing Site: b) Head Office :
PLOT NO.90, SECTOR-IIDC, Aries Drugs Pvt. Ltd.
SIDCUL, PANTNAGAR-263145.(U.K) S-89/16, D-Block, Rajajipuram,
E-mail : [email protected] Lucknow-226017.
Website : www.ariesdrugs.com Tel No. 0522-3298260
Mobile : 09335291145/46/47
Tel No : (05944) 250546,
Mobile : 0 9335291146 / 0 9335291145
1.4 Details of our Products and Process:
PRODUCTION FLOW CHARTS
RAW & PACKING MATERIAL MOVEMENT

RM/PM Receipt

De Dusting &
Record Recection. RM
Return to party

Sampling, Testing Rejection Unprinted PM

Report Return to party

Printed PM
Passes
Destroy

Approved
Material store

Dispensing
Primary PM

In-process

Sampling
Testing

Rejection Report
Passes Rejected

Semi Finished Rework Destroy

Product

Sampling Packaging Finished Quality

Passes Approved Dispatch
Testing Product
1.5 REFER LIST OF PRODUCTS

LIST OF PRODUCTS

Sr No BRAND NAME COMPOSITION PACK

Each 5 ml contain.
IRON (III) HYDROXIDE
1. POLYFER SYRUP POLYMALTOSE COMPLEX 50mg.
200 ML
FOLIC ACID I.P. 0.5mg
Each 5 ml contain.
2. ARIZYME SYRUP 50mg.
FUNGAL DIASTASE(1:12000) I.P. 200 ML
PEPSIN(1:3000) I.P. 10mg.
Each 5 ml contain.
FERROUS GLUCONATE I.P. 300mg.
3. FECAL SYRUP CALCIUM GLUCONATE I.P. 125mg. 200 ML
CYANOCOBALMINE I.P. 10mcg.
FOLIC ACID I.P. 1.5mg
Each 5 ml contain.
4. ARIFER SYRUP SODIUM FEREDETATE B.P. 231mg. 200ML
FOLIC ACID I.P. 0.5mg.
Each 5 ml contain.
CALCIUM CARBONATE
5. SEAGEM-L SUSPENSION (OYSTER SHELL) I.P. 625mg. 200ML
VITAMIN D3 I.P. 125 I.U
L-LYSINE USP 70mg.
Each 5 ml contain.
MAGALDRATE I.P. 400mg.
6. NOVACID SUSPENSION SIMETHICONE I.P. 20mg. 170 ML

Each 5 ml contain.
7. CETEN SYRUP CETIRIZINE 60 ML
DIHYDROCHLORIDE BP 5mg
Each 5 ml contain.
8. SUPAR SUSPENSION NIMESULIDE B.P. 50mg. 60 ML
PARACETAMOL I.P. 125mg.
Each 5 ml contain.
9. ARO SUSPENSION OFLOXACIN . I.P. 50mg 60 ML

Each 5 ml contain.
10. ARO-OZ SUSPENSION OLFLOXACIN I.P. 50mg. 60 ML
ORNIDAZOLE 125mg.
Each 5 ml contain.
OFLOXACIN I.P. 100mg.
11. AROMET SUSPENSION METRONIDAZOLE BENZOATE 60 ML
(EQ. TO METRONIDAZOLE) I.P. 200mg.

Each 5 ml contain.
CHLORPHENIRAMINE
MALEATE I.P. 2.5mg.
12. ARITONE SYRUP AMMONIUM CHLORIDE I.P. 125mg.
100ML
SODIUM CITRATE I.P. 55mg.
MENTHOL I.P. 1mg.
 Each 5 ml contain.
DIPHENHYDRAMINE HCL I.P. 14.08mg.
AMMONIUM CHLORIDE I.P. 138mg.
13 ARYDRYL SYRUP SODIUM CITRATE I.P. 57.03mg. 100 ML
MENTHOL I.P. 1.14mg.

Each 5 ml contain.
BROMHEXINE HCL I.P. 4mg.
GUAIPHENESIN I.P. 50mg.
14. BROX-CZ SYRUP CETIRIZINE 100ML
DIHYDROCHLORIDE B.P. 2.5mg.
MENTHOL I.P. 1mg.

Each 10 ml contain.
SUCRALFATE USP 1mg.
15 ARIFATE –O SUSPENSION OXETACAINE B.P. 10mg. 100ML

Each 5 ml contain.
PARACETAMOL I.P. 125mg.
PHENYLPROPANOLAMINE
16. NOCOLD SYRUP HCL B.P. 2.5mg. 100ML
CHLORPHENIRAMINE
MALEATE I.P. 1mg.

Each 5 ml contain.
CYPROHEPTADINE HCL . I.P. 2mg.
17. CYPOT SYRUP TRICHOLINE CITRATE 0.275gm 200 ML
SORBITOL SOLUTION(70%) I.P. 3.575gm

Each 5 ml contain.
18. CITRAL SYEUP DISODIUM HYDROGEN 100 ML
CITRATE B.P. 1.53gm
Each 5 ml contain.
DEXTROMETHORPHAN
HYDROBROMIDE I.P. 10mg.
PHENYLPROPANOLAMINE
19. ARICOF SYRUP HCL B.P 10mg.
100 ML
CHLORPHENIRAMINE
MALEATE I.P 2mg.
MENTHOL I.P. 1.5mg
Each 5 ml contain.
NIMESULIDE B.P. 50mg.
20. NSP SUSPENSION PARACETAMOL I.P. 125mg. 60ML

Each 5 ml contain.
DRIED ALUMINIUM
21. ARICID SUSPENSION HYDROXIDE GEL I.P. 200mg. 170ML
MAGNESIUM HYDROXIDE I.P. 200mg.
SIMETHICONE I.P. 25mg.
Each 5 ml contain.
22 OFCIN SUSPENSION OFLOXACIN . I.P. 50mg.
60 ml
Each 5 ml contain.
23. OFCIN-OZ SUSPENSION OFLOXACIN I.P. 50mg. 60ML
ORNIDAZOLE 125mg.
 Each 5 ml contain.
CYPROHEPTADINE HCL . I.P. 2mg.
24. LIVOTOP SYRUP TRICHOLINE CITRATE 0.275gm 200ML
SORBITOL SOLUTION(70%) I.P. 3.575gm

Each 5 ml contain.
CHLORPHENIRAMINE
MALEATE I.P. 2.5mg.
25. LCTONE SURUP AMMONIUM CHLORIDE I.P. 125mg. 100ML
SODIUM CITRATE I.P. 55mg.
MENTHOL I.P. 1mg.

Each 10 ml contain.
26. ARIFATE SUSPENSION SUCRALFATE USP 1gm. 100ML

Each 5 ml contain.
FUNGAL DIASTASE(1:1200) I.P. 50mg.
27. PEPZYME SYRUP PEPSIN(1:3000) I.P. 10mg 200ML

Each 5 ml contain.
FERROUS GLUCONATE I.P. 300mg.
28. CALCITONE-F SYRUP CALCIUM GLUCONATE I.P. 125mg. 200ML
CYANOCOBALMINE I.P. 10mcg.
FOLIC ACID I.P. 1.5mg
Each 5 ml contain.
CARBONYL IRON EQ. TO
ELEMENTAL IRON 60mg.
29. CARBOZ-SYRUP VIT. B12 I.P. 7.5mcg. 200ML
FOLIC ACID I.P. 0.75mg.
ZINC(as zinc sulphate I.P.) 11.25mg.
1.6 Site Synopsis:
The site is situated at Integrated Industrial Estate, Pant Nagar about 5 km away from Rudrapur
city (Uttarakhand). It is accessible by rail as well as by road, about 237 km from Delhi, and
about 300 km from Dehradun. The total area of the plot is approximately 1971.40 sq. yard. The
plot is situated in pollution free environment.

1.7 Human Resource :

Sr. No. Department Strength

Production staff
1. 04
Quality Control
2. 03
Engineering Services
4. 02
Stores
5. 02
Administration
6. 03
Security
7. 02
House keeping
9. 05
Regulatory 01
10.
11 Operator 05

Total 27
2.0 PERSONNEL
2.1 LIST OF KEY TECHNICAL PERSONNEL AT PANTNAGAR SITE

Company’s Responsible Person

Sr. No. Name Brief Biodata
Designation - Managing Director/ Plant Head
Education - B.Com
Experience - Looking after the entire portfolio of
01 Mr. Amit Agarwal
Aries which includes the Sales,
marketing, Legal & periodicals and
manufacturing
Designation - Production In-Charge
Education - B.Sc
Experience – 7 years experience in production,
02 Mr. Ashok Jaiswal
Approved from Uttaranchal
government in Tablet, Capsule
& Liquid section
Designation - QC In-Charge
Education - B.Sc
03 Mr. Kailash Dass Experience – 4 years experience in QC Department,
Approved from Uttaranchal
government in Chemical analysis
Designation - Store In-Charge
Education - B.Com
04 Mr. Anoop Dutta
Experience – 3 years experience in store department

2.2 Health Requirement :

The company ensures that pre-employment and periodical medical check up is conducted for all
employees.

2.3 Training Program :

A detailed SOP for Training Program and a Training Manual is prepared by QC, in consultation
with Plant head, HR and Departmental heads. This covers Induction training, On the job training,
External training in cGMP, Health, Safety, Environment, personnel hygiene, instrumentation.
The trainings conducted are documented and evaluated.
3.0 PREMISES, FACILITIES AND EQUIPMENT:
PREMISES:
3.1 Manufacturing areas:

Manufacturing facilities are segregated as per cGMP norms and separate buildings have been
provided for Specialty Formulations, Oral Liquid Section.
3.2 Nature of construction and fixtures / fittings:
Nature of construction : Brick & RCC
External finish : Cement plaster with snowcem finish
Internal Finish : The manufacturing areas are made up of
a. Stone Flooring
b. Polyurethane coatings on walls and ceilings.
In other areas, Internal walls and ceilings are plastered with cement to smooth finish and painted
with glossy washable antibacterial and antifungal paint. Peripheral areas, which are other than
the production areas, are constructed by civil structure.

3.3 Water System (DM water)

RO UNIT :- Model- INDRO-403 , MAKE – ION EXCHANGE INDIA LIMITED.
The water treatment system consists of treatment of water at various stages and passage through
various filters as per the details given below:
• Bore well source is from artesian well designed to feed water
• Filtration through multi-grade filter
• Softener
• Antiscallent dosing
• RO
• Mix bed
• pH Stabilization
• Pass through UV.
• DM water
3.4 Distribution of DM Water:
The distribution loops are made of SS with orbital arc welding and continuous flow of water
with the provision of sampling points and user points, wherever required.

3.5 Preventive Maintenance:

The preventive maintenance of the systems, building and premises including painting is carried
out as per schedule.
The ventilation and water systems are periodically serviced and checked for overall
performance.
Records are maintained as follows:
The equipments are divided into -
a) Utility Equipments
b) Production Equipments
Preventive maintenance documents are maintained separately. The schedule for preventive
maintenance is formulated on annual basis for each manufacturing unit with specific break up of
weekly / fortnightly / monthly / quarterly and half-yearly maintenance schedules.
A list of major equipments and machinery used in production has been attached.
3.6 Validation and Calibration

Validation Master Plan is prepared by QC in line with the philosophy of Aries Drugs Private
Limited to plan and execute validation activities in the facility according to Validation Matrix.

All critical equipments, instruments and utilities are subjected to followed by DQ, IQ, OQ and
PQ. In case of any changes, revalidation is performed accordingly.

Records are kept with detailed information for each equipment such as details of calibration
standards and limits, responsibilities for performing calibration, intervals between calibration,
record-keeping requirements and logs, and actions to be taken. The following validations are
carried out:
• Water Validation
• Equipment Validation
• QC Instrument / Analytical Method Validation
 Calibration of equipments by external agencies is carried out periodically and the tag indicating
next calibration due is affixed on individual equipment.

3.7 SANITATION

Sanitation and Cleaning to ensure that the system is cleaned properly to be free from product,
detergent and microbial flora to specified level to prevent contamination.

Written guidelines and procedures for cleaning specifications, cleaning agents and their
concentration to be used are available.

In critical process areas, the equipments / machinery have been provided with CIP and SIP
systems. Written SOPs are in place for cleaning and sanitization of manufacturing areas.
Separate SOPs are available for cleaning of individual equipment / machinery, which are
followed, & records are maintained thereof.

4.0 DOCUMENTATION

4.1 Documentation is an essential part of the Quality Assurance/Quality Control System. Its purpose
is to define the system control and to specify / record various activities carried out and to ensure
effective implementation.

Documentation system includes the history for each batch of product. It includes the
information on utilization and processing of starting materials, packaging materials and
intermediate, bulk and finished products.

Master documents such as Master Specification, Master Formula Card and Master File for each
raw material, packing material and finished product are available with QA/QC department.
5.0 PRODUCTION
5.1 Materials are procured from approved vendors against purchase order. The materials received at
warehouse are cleaned free of dust by vacuum cleaner, checked for physical defects and kept in
quarantine till QC sampling is done. After the QC Report, approved materials are shifted to
Approved Area and if rejected, transferred to Rejected Materials Area. Rejected materials are
kept under lock and key till they are returned to the vendor in case of raw materials and till they
are destroyed, in case of printed packing materials.
QC sampling and dispensing of raw materials is done under the specified areas. Dispensed
materials are moved to ‘Day Store’ till taken up for production.
After production, the finished goods are maintained in the quarantine pending QC release. Once
the QC release is obtained, the finished products are transferred to BSR.
FACILITIES:

Documentation (cGMP)

Latest Equipment/Instruments for manufacturing.

AHU with 0.5µ filter.

Fresh air system

Cooling system

Fresh air & AHU with 0.5µ filter In Manufacturing & packing area.
5.2 Flow sheets ORAL LIQUID PRODUCTION

BATCH MANUFACTURING
RECORD

RAW MATERIAL
REQUISITION
(FORMULATION ORDER)

DISPENSING OF RAW
MATERIALS

MANUFACTURING
PROCESS

BULK

SAMPLING TESTING

QC RELEASE

IPQC
FILLING PACKING MATERIAL
REQUISITION

LABELING

IPQC RELEASE FOR PACKAGING DISPENSING OF PM

PACKING

SAMPLING &
INSPECTION

QC RELEASE

TRANSFER TO
STORE
DEPARTMENT
5.3 LIST OF MAJOR EQUIPMENT AT PLANT

ORAL LIQUID SECTION

S.NO. NAME OF THE EQUIPMENT MAKE MODEL

Sugar preparation tank with double
Pyramid Industries
1 Heater.
(Ahmadabad)
(Capacity 750 Lit.) GMP Model
Manufacturing tank with stirrer and cooling
Pyramid Industries
2 facilities and In Line Homogenizer.
(Ahmadabad)
( Capacity 1000 Lit.) GMP Model
3 Filter Press Pyramid Industries -
Storage tank with stirrer Pyramid Industries
4
( Capacity 1000 Lit.) (Ahmadabad) GMP Model
Excel Engineering
Rotary Bottle washing machine
5 (Ahmadabad)
with air dryer
ERWM-64
Automatic four head Volumetric Liquid National Pharma
6
Bottle Filling machine Machinery NALF-100
National Pharma
7 Automatic four head Cap Sealing machine
Machinery NARCS-100
National Pharma
8 Automatic cap feeder machine
Machinery NARCS-100
Excel Engineering
9 Inspection table
(Ahmadabad) EPCB
Labeling machine with vacuum system Koldpack Machineries KHL-ISO
10
P. Limited (Ahmadabad)
6.0 QUALITY CONTROL
Quality Control laboratories have been equipped with latest equipments & Instruments.

6.1 Quality control shall deal with sampling, specifications, testing, documentation, release
procedure and ensure implementation of the relevant protocol
The QC Lab has got the following sections:
• Chemical
• Instrumentation
• Packing materials testing
• Microbiology
• Re-agents and storage
• Control Samples
• Record Room
• Heating Equipments Area
• Stability Studies
• Wash Area

6.2 FACILITIES

General facilities

The testing facility of analytical lab are designed as

 Instrumentation lab
 Chemical analysis lab
 Microbiology lab

Specimen and data storage facilities

Separate Room and cupboards are provided for storing the samples before and after
analysis. All analytical data are entered in a prescribed protocol sheet based on which a
test report is prepared. The data are filed according to the serial number of COA.
 Administrative and personnel facilities

All the administrative work related to the laboratory are supervised by

QC In charge.

Facilities for hand-wash and toilet are adequately provided.

6.3 Quality Management System:

Our policy states:

“The commitment of the company is to ensure, that the products it develops, manufactures and
distributes, meet the predetermined specification related to quality of its products consistently”.
It assures the products are manufactured in adherence to the current Good Manufacturing
Practices (cGMP) in conformity with national regulations.

The role of Quality Quality Control is to ensure design and development of pharmaceutical
products taking into account the requirements of Good Manufacturing Practices (GMP), Good
Laboratory Practices (GLP) Good Documentation Practices (GDP). Adequate controls on
starting materials, bulk products and other in-process controls, calibrations and validations are
carried out.

The effective quality management is achieved through systematic sampling, testing, validating
and monitoring of materials, facilities, systems and procedures, which can have direct impact on
the quality of the products throughout their shelf life. Much importance is given to in-process
controls on the guidelines given under Process The Standard Operating Procedures (SOPs), duly
authorized for all operations including Production, Quality Control, Distribution, Safety,
Environmental Control, Housekeeping and Engineering are the other important part of Quality
Management System.
Self-inspection and Audits are part of effective implementation of Quality Management
System. Inspection, evaluation, rating and approval of vendors for supplies of raw
materials, excipients and packing materials are carried out in conformity to the Good
Manufacturing Practices.
6.4 LIST OF EQUIPMENTS / INSTRUMENTS IN QA/QC LAB

Sr. No. Equipment / Instrument Make Model Qty

Name
1. UV-Vis. Spectrophotometer Systronics 117 1
2. Refractometer Advance R-8 1
3. K. F. Titrator EI 761 1
4. Analytical Balance Vibra HT-220E 1
5. Polarimeter Advance PA-1R 1
6. pH Meter Toshcon CL 54+ 1
7 Conductivity Meter Toshcon TCM 15+ 1
8 Melting Point apparatus EI 931 1
9 Muffle Furnace Shivaki T-701 1
10 Hot air Oven J.S. Enterprises - 1
11 Vacuum Oven S.M. Scientific - 1
12 Water Bath J.S. Enterprises - 1
13 Hot plate J.S. Enterprises - 1
14 Heating mantel J.S. Enterprises - 1
15 UV Cabinet J.S. Enterprises - 1
6.5
QC FLOW SHEET

IN PROCESS AND FINISHED PRODUCTS ANALYSIS

DISPENSING

BULK SOLUTION

Description

pH

Fill volume

Wt./ml

Assay

TEST:

1- PHARMACOPOEAL SPECIFICATIONS

2- IN HOUSE SPECIFICATIONS
6.6 PACKAGING MATERIAL ANALYSIS AND RELEASE

PRIMARY PACKAGING MATERIAL& SECONDARY PACKING MATERIALS

PRIMARY SECONDARY

PET BOTTLE PP CAP LABEL CARTON CORRUGATED

BOX

PHYSICAL PHYSICAL PHYSICAL PHYSICAL PHYSICAL

DIMENSIONS DIMENSIONS DIMENSIONS DIMENSIONS DIMENSIONS

CHEMICAL CHEMICAL CHECKING OF CHECKING OF GRAMMAGE &

TESTING TESTING PRINTED MATTER PRINTED MATTER PRINTED MATTER

COMPLIES COMPLIES COMPLIES COMPLIES COMPLIES

RELEASE RELEASE RELEASE RELEASE RELEASE

7.0 STORE DEPARTMENT
General facilities

 Documentation
 Separate Under Test area with yellow coloured mark on floor.
 Separate Approved area with Green coloured mark on floor.
 Separate Rejected area with Red coloured mark on floor.
 Cooling area
 Dispensing & Sampling Booth with LAF
 Cold storage area for Multivitamins and other raw material.
 Finish goods storage area.
 Primary & Secondary Packing materials area.

8.0 CONTRACT MANUFACTURE & LICENSE SHEET

The Contract Manufacturing can be undertaken on either as Loan License or principle to
principle (P to P) basis.
In P to P basis- All the materials shall be arranged by the manufacturer & License shall also be
arranged by manufacturer under the brand name of marketing company.
The Loan License- Under the Loan license The Manufacturing is done with the materials
supplied by the Licensee & the license for the manufacturing is to be arranged by the marketing
company at our premises.
All the manufacturing activities are done under strict supervision of technical staff following
latest cGMP norms.

9.0 DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL

Warehousing areas are designed and good storage and distribution practice are adopted.
The areas are maintained within acceptable temperature limit. Controlled storage condition is
monitored constantly.
Distribution details are maintained batch wise to facilitate recall of goods, if required.

9.1 Handling of Complaints and Product Recalls

A Standard Operating Procedure is available for the handling of complaints and Product Recall
Procedure is in place. Complaints will be investigated by QC department as per written
procedure and the QC Manager instructs further action / recall.
9.2 SELF-INSPECTION
Periodical internal audits (self inspection) are carried out as per the SOP of Internal Audit.
Internal audit is either conducted by the internal audit team or by authorized QA/QC personnel.
Internal auditors, who form the audit team, are selected from various departments except the
auditee department.

The auditors prepare internal audit reports and the concerned Department Head is required to
submit the corrective action plan.

External experts are also called periodically to evaluate our working on the principles of GMP,
GLP, GDP.
10.0 ORGANIZATION CHART:

ORGANOGRAM OF PANTNAGAR SITE

Mr. HARIOM AGARWAL

CHAIRMAN

_________________________________________________________

Mrs. MUKUL AGARWAL Mr. AMIT AGARWAL

(MARKETING DIRECTOR) (DIRECTOR & PLANT HEAD)

Mr. SUSHANT RAI AGRWAL Mr. ROBIN MATHEW

(H.R & ADMINISTRATION.) (DIRECTOR)

MARKETING MANAGER __________________________

Mr. ASHOK JAISWAL Mr. KAILASH DASS

(PRODUCTION INCHARGE) (QC INCHARGE)
MEDICAL
REPRESENTATIVES

Mr. ANOOP DUTTA

DISTRIBUTORS (STORE INCHARGE)