Plot no. 90

Sector-IIDC, Sidcul,

Pant Nagar- 263 145,

UTTARAKHAND,

E-mail : ariesdrugslko@yahoo.com

Website : www.ariesdrugs.com

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

SITE MASTER FILE

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

ARIES DRUGS PRIVATE LIMITED

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 : ariesdrugslko@yahoo.com 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

Sampling, Testing

Approved

Material store

Dispensing

In-process

Sampling

Testing

Semi Finished

Product

Sampling

Testing

Packaging Finished

Product

Quality

Approved

De Dusting &

Record

Rejected

Rejection Report Passes

Passes

Primary PM

Rejection

Report

Passes

Dispatch

Rework

Recection. RM

Return to party

Unprinted PM

Return to party

Printed PM

Destroy

Destroy

1.5 REFER LIST OF PRODUCTS

LIST OF PRODUCTS

Sr No BRAND NAME COMPOSITION PACK

1. POLYFER SYRUP

Each 5 ml contain.

IRON (III) HYDROXIDE

POLYMALTOSE COMPLEX 50mg.

FOLIC ACID I.P. 0.5mg

200 ML

2. ARIZYME SYRUP Each 5 ml contain.

FUNGAL DIASTASE(1:12000) I.P. 50mg.

PEPSIN(1:3000) I.P. 10mg. 200 ML

3. FECAL SYRUP

Each 5 ml contain.

FERROUS GLUCONATE I.P. 300mg.

CALCIUM GLUCONATE I.P. 125mg.

CYANOCOBALMINE I.P. 10mcg.

FOLIC ACID I.P. 1.5mg

200 ML

4. ARIFER SYRUP Each 5 ml contain.

SODIUM FEREDETATE B.P. 231mg.

FOLIC ACID I.P. 0.5mg. 200ML

5. SEAGEM-L SUSPENSION

Each 5 ml contain.

CALCIUM CARBONATE

(OYSTER SHELL) I.P. 625mg.

VITAMIN D3 I.P. 125 I.U

L-LYSINE USP 70mg.

200ML

6. NOVACID SUSPENSION

Each 5 ml contain.

MAGALDRATE I.P. 400mg.

SIMETHICONE I.P. 20mg.

170 ML

7. CETEN SYRUP Each 5 ml contain. CETIRIZINE

DIHYDROCHLORIDE BP 5mg 60 ML

8. SUPAR SUSPENSION Each 5 ml contain.

NIMESULIDE B.P. 50mg.

PARACETAMOL I.P. 125mg. 60 ML

9. ARO SUSPENSION Each 5 ml contain.

OFLOXACIN . I.P. 50mg

60 ML

10. ARO-OZ SUSPENSION Each 5 ml contain.

OLFLOXACIN I.P. 50mg.

ORNIDAZOLE 125mg. 60 ML

11. AROMET SUSPENSION

Each 5 ml contain.

OFLOXACIN I.P. 100mg. METRONIDAZOLE BENZOATE

(EQ. TO METRONIDAZOLE) I.P. 200mg.

60 ML

12. ARITONE SYRUP

Each 5 ml contain.

CHLORPHENIRAMINE

MALEATE I.P. 2.5mg.

AMMONIUM CHLORIDE I.P. 125mg.

SODIUM CITRATE I.P. 55mg.

MENTHOL I.P. 1mg.

100ML

13 ARYDRYL SYRUP

Each 5 ml contain.

DIPHENHYDRAMINE HCL I.P. 14.08mg.

AMMONIUM CHLORIDE I.P. 138mg.

SODIUM CITRATE I.P. 57.03mg.

MENTHOL I.P. 1.14mg.

100 ML

14. BROX-CZ SYRUP

Each 5 ml contain.

BROMHEXINE HCL I.P. 4mg.

GUAIPHENESIN I.P. 50mg.

CETIRIZINE

DIHYDROCHLORIDE B.P. 2.5mg.

MENTHOL I.P. 1mg.

100ML

15 ARIFATE –O SUSPENSION

Each 10 ml contain.

SUCRALFATE USP 1mg.

OXETACAINE B.P. 10mg.

100ML

16. NOCOLD SYRUP

Each 5 ml contain.

PARACETAMOL I.P. 125mg.

PHENYLPROPANOLAMINE

HCL B.P. 2.5mg.

CHLORPHENIRAMINE

MALEATE I.P. 1mg.

100ML

17. CYPOT SYRUP

Each 5 ml contain.

CYPROHEPTADINE HCL . I.P. 2mg.

TRICHOLINE CITRATE 0.275gm

SORBITOL SOLUTION(70%) I.P. 3.575gm

200 ML

18. CITRAL SYEUP Each 5 ml contain.

DISODIUM HYDROGEN

CITRATE B.P. 1.53gm 100 ML

19. ARICOF SYRUP

Each 5 ml contain.

DEXTROMETHORPHAN

HYDROBROMIDE I.P. 10mg.

PHENYLPROPANOLAMINE

HCL B.P 10mg.

CHLORPHENIRAMINE

MALEATE I.P 2mg.

MENTHOL I.P. 1.5mg

100 ML

20. NSP SUSPENSION

Each 5 ml contain.

NIMESULIDE B.P. 50mg.

PARACETAMOL I.P. 125mg.

60ML

21. ARICID SUSPENSION

Each 5 ml contain.

DRIED ALUMINIUM

HYDROXIDE GEL I.P. 200mg.

MAGNESIUM HYDROXIDE I.P. 200mg.

SIMETHICONE I.P. 25mg.

170ML

22 OFCIN SUSPENSION Each 5 ml contain.

OFLOXACIN . I.P. 50mg.

60 ml

23. OFCIN-OZ SUSPENSION Each 5 ml contain.

OFLOXACIN I.P. 50mg.

ORNIDAZOLE 125mg. 60ML

24. LIVOTOP SYRUP

Each 5 ml contain.

CYPROHEPTADINE HCL . I.P. 2mg.

TRICHOLINE CITRATE 0.275gm

SORBITOL SOLUTION(70%) I.P. 3.575gm

200ML

25. LCTONE SURUP

Each 5 ml contain.

CHLORPHENIRAMINE

MALEATE I.P. 2.5mg.

AMMONIUM CHLORIDE I.P. 125mg.

SODIUM CITRATE I.P. 55mg.

MENTHOL I.P. 1mg.

100ML

26. ARIFATE SUSPENSION Each 10 ml contain.

SUCRALFATE USP 1gm.

100ML

27. PEPZYME SYRUP

Each 5 ml contain.

FUNGAL DIASTASE(1:1200) I.P. 50mg.

PEPSIN(1:3000) I.P. 10mg

200ML

28. CALCITONE-F SYRUP

Each 5 ml contain.

FERROUS GLUCONATE I.P. 300mg.

CALCIUM GLUCONATE I.P. 125mg.

CYANOCOBALMINE I.P. 10mcg.

FOLIC ACID I.P. 1.5mg

200ML

29. CARBOZ-SYRUP

Each 5 ml contain.

CARBONYL IRON EQ. TO

ELEMENTAL IRON 60mg.

VIT. B12 I.P. 7.5mcg.

FOLIC ACID I.P. 0.75mg.

ZINC(as zinc sulphate I.P.) 11.25mg.

200ML

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

1. Production staff

04

2. Quality Control

03

4. Engineering Services

02

5. Stores

02

6. Administration

03

7. Security

02

9. House keeping

05

10. Regulatory

01

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

01 Mr. Amit Agarwal

Designation - Managing Director/ Plant Head

Education - B.Com

Experience - Looking after the entire portfolio of

Aries which includes the Sales,

marketing, Legal & periodicals and

manufacturing

02 Mr. Ashok Jaiswal

Designation - Production In-Charge

Education - B.Sc

Experience – 7 years experience in production,

Approved from Uttaranchal

government in Tablet, Capsule

& Liquid section

03 Mr. Kailash Dass

Designation - QC In-Charge

Education - B.Sc

Experience – 4 years experience in QC Department,

Approved from Uttaranchal

government in Chemical analysis

04 Mr. Anoop Dutta

Designation - Store In-Charge

Education - B.Com

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

SAMPLING TESTING

QC RELEASE

BATCH MANUFACTURING

RECORD

RAW MATERIAL

REQUISITION

(FORMULATION ORDER)

DISPENSING OF RAW

MATERIALS

MANUFACTURING

PROCESS

PACKAGING

PACKING MATERIAL

REQUISITION

LABELING

RELEASE FOR

PACKING

FILLING

DISPENSING OF PM

BULK

IPQC

IPQC

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

1

Sugar preparation tank with double

Heater.

(Capacity 750 Lit.)

Pyramid Industries

(Ahmadabad) GMP Model

2

Manufacturing tank with stirrer and cooling

facilities and In Line Homogenizer.

( Capacity 1000 Lit.)

Pyramid Industries

(Ahmadabad) GMP Model

3 Filter Press Pyramid Industries -

4 Storage tank with stirrer

( Capacity 1000 Lit.)

Pyramid Industries

(Ahmadabad) GMP Model

5 Rotary Bottle washing machine

with air dryer

Excel Engineering

(Ahmadabad)

ERWM-64

6 Automatic four head Volumetric Liquid

Bottle Filling machine

National Pharma

Machinery NALF-100

7 Automatic four head Cap Sealing machine National Pharma

Machinery NARCS-100

8 Automatic cap feeder machine National Pharma

Machinery NARCS-100

9 Inspection table Excel Engineering

(Ahmadabad) EPCB

10 Labeling machine with vacuum system

Koldpack Machineries

P. Limited (Ahmadabad)

KHL-ISO

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

Name

Make Model Qty

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

DIMENSIONS

PHYSICAL

DIMENSIONS

PHYSICAL

DIMENSIONS

PHYSICAL

DIMENSIONS

PHYSICAL

DIMENSIONS

CHEMICAL

TESTING

CHEMICAL

TESTING

CHECKING OF

PRINTED MATTER

CHECKING OF

PRINTED MATTER

GRAMMAGE &

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

Mr. AMIT AGARWAL

(DIRECTOR & PLANT HEAD)

Mr. ROBIN MATHEW

(DIRECTOR)

Mr. ASHOK JAISWAL

(PRODUCTION INCHARGE)

Mr. KAILASH DASS

(QC INCHARGE)

Mr. ANOOP DUTTA

(STORE INCHARGE)

Mr. SUSHANT RAI AGRWAL

(H.R & ADMINISTRATION.)

Mrs. MUKUL AGARWAL

(MARKETING DIRECTOR)

MARKETING MANAGER

MEDICAL

REPRESENTATIVES

DISTRIBUTORS