AR L FESCIENCES819/B Rakanpur Indl. Area, Tal. Kalol, Dist. Gandhinagar, Gujarat-60

The objective of the company is to

produce wide range of

pharmaceutical formulations like

Tablet and Capsule dosage forms.

OBJECTIVEBuild quality into the

products with

established quality systems with the help of a team of well-trained and

technically qualified, competent & committed

personnel.

BELIEF

AR LIFESCIENCES

BELIEF & OBJECTIVE

AR LIFESCIENCES is a newly commissioned,

professionally managed Private company.

The location of factory building avoids

contamination from open sewage, drain, public

lavatory or any factory which produces

disagreeable or obnoxious odour or fumes or large

quantity of soot, dust or smoke.

The site is located at Rakanpur, 25 Kms. to the

West of Ahmadabad Railway Station, and

Ahmadabad in Gujarat State of India. The plant

has been designed to meet the requirements of

cGMP (Current Good Manufacturing Practices) as

specified by W.H.O and different guidelines

published from time to time.

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ABOUTUS…

The building used for the factory is constituted to permit

production of drugs under hygienic conditions. Construction of

buildings ensures protection of product from contamination and

permits efficient cleaning. Entire premises are maintained in a

clean and tidy condition.

The plant is designed in logical order corresponding to the

sequence of the operations and to maintain the requisite

cleanliness levels at all stages of manufacturing operations.

The firm is situated in a pollution free environment of village

Rakanpur. The total area of the plot is about 1408.55 sq.mt and

built up area is approximately 1209.73 sq.mt. The buildings are

consisting of ground floor, first floor and second floor. Ground

floor and first floor is provided for manufacturing operations of tablets and Capsules and Quality Control Department. Second

floor is provided for various utility system like AHU systems &

Water plants.

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ABOUTUS…

KEY PERSONNEL

(Partners)Qualification : B.Com

Experience : 25 yrs

Mr. Aman Madaan & Mr. Rishi Madaan

(Head QA)Qualification : B.SC (Chemistry)

Experience : 20 yrs

Mr. Jiten Dave

(Head Production [Tablet Section])Qualification : M.SC (Chemistry)

Experience : 15 yrs

Mr. Krishnakumar Singh

(Plant Head )Qualification : B.Com Experience : 20 yrs

Mr. Karan Bist

(Executive QC)Qualification : B.SC (Bio-Chemistry)

Experience : 2 yrs

Mr. Dipen Patel

(Microbiologist QC)Qualification : M.SC (Microbiology)

Experience : 1 yrs

Mr. Shiten Patel

(Executive QA)Qualification : B.Pharm

Experience : 1 yrs

Ms. Jinal Parmar

(Head Production [Capsule Section])Qualification : B.SC (Chemistry)

Experience : 35 yrs

Mr. Uday Raj Singh

(Executive Maintenance & Utility)Qualification : B.E Electrical

Experience : 4 yrs

Mr. Viral Patel

(Executive RM-PM Store)Qualification :M.SC

(Inorganic Chemistry)Experience : 1 yrs

Mr. Pravin Kashid

Name Designation Qualification Experience

Mr. Aman Madaan & Mr. Rishi Madaan

Partners B.Com 25 Years

Mr. Karan Bist Plant Head B.Com 20 Years

Mr. Jiten Dave Head QA B.SC (Chemistry) 20 Years

Ms. Jinal Parmar Executive QA B.Pharm 1 Year

Mr. Gautam Patel Head QC M.SC (Organic-Chemistry) 4 Years

Mr. Dipen Patel Executive Head QC B.SC (Chemistry) 2 Years

Mr. Shiten Patel Microbiologist QC M.SC (Microbiology) 5 Years

Mr. KrishnaKumar Singh Head Production (Tablet Section) M.SC (Chemistry) 15 Years

Mr. UdayRaj SinghHead Production (Capsule

Section)B.SC (Chemistry)

35 Years

Mr. Viral Patel Executive Maintenance & Utility B.E (Electrical) 4 Years

Mr. Pravin Kashid Executive RM-PM StoreM.SC (Inorganic

Chemistry)1 Year

KEY PERSONNEL

PLANT INFRASTRUCTURE

PLANT INFRASTRUCTURE

❑ AHU System:

▪ We have total 20 No. of Air Handling Units (AHU).

▪ All Critical Manufacturing Processing areas like Sampling, dispensing, Granulation Compression, Coating, Primary packing, capsule filling, polishing ,Sealing where the product is exposed to environment are equipped with HVAC system.

❑ Details of AHUs:

▪ Total 20 air handling unit to maintain & control pre defined environmental parameter

▪ Return Air Mixing Chamber

▪ Pre- Filter chamber:10 micron

▪ Cooling coil chamber

▪ Heater Chamber

▪ Fan chamber

▪ Terminal filter 5.0micron Filter.

▪ Supply Air Chamber

▪ Schedule for routine monitoring and Validation of HVAC parameters like Air velocity, Air changes, Particle count, recovery time, test etc. shall be twice in a year.

PRODUCTION INFRASTRUCTURE INFORMATION

▪ The quality of water shall be maintained stringently by routine microbiological and chemical tests of R.O. Water and Purified water. Purified water is prepared from R.O. Water. Microbial population in potable water shall be control by chlorination. The microbiological limit for potable water is less than 500 CFU per/ml and absence of pathogens such as E.coli, Salmonella, Staphylococcus aureus and Pseudomonas aeroginosa.

▪ Loop system is installed for purified water distribution. All user points shall be validated by chemical and microbiological testing.

▪ The main source of water is ground water, which is stored in a storage tank of 25000 liter capacity.

▪ Purified water shall be stored in 10000 Liters capacity tank

▪ All supply lines are made up of SS 316

▪ Capacity of water Plant : 500 Liters/Hr

▪ Raw Water and, Purified Water shall be tested as per schedule.

▪ SANITATION: Raw water is supplied by Borewell. Purified water plant shall be sanitized as per schedule by Hydrogen Peroxide dosing. Purified water collected in tank is passed through a filter and U.V. bank. Purified water tank and loop system is sanitized by circulating hot purified water .

WATER SYSTEM

NMT 1.0 micro

mhoh

5.00 to 7.00

100 CFU/ml

Should be Absent

As per

Specifications

1PH

2Conductivity

3Bacteria

4Fungus

5Other Test

ACCEPTANCE CRITERIA FOR PURIFIED WATER

WATER SYSTEM

Raw Water Tank

Water Pump

SF ACF HPUV

RO Reject Line

RO Plant 500 LPH

Pure Water Line

RO Water Storage Tank

844 vessel

CationResin

1252 vessel

anions Resin

1054 vessel

CationResin

DM Plant

Pure Water Storage Tank

Water Pump

AR LIFESCIENCES manufactures stable and therapeutically effective formulations in

independent manufacturing facilities. The

facilities are well-equipped to produce

Tablets and Capsules, manufacturing

facilities is cGMP compliant as per WHO

guidelines having a team of well-trained

professionals that take care of initial

Production planning to the final Quality

Control Testing and Analysis. The team

ensures that the products are manufactured

in accordance with global standards and

customer specifications at all times.

MANUFACTURING FACILITIES

All manufacturing operations shall be carried out under the

supervision of an adequately qualified and a trained person. All

materials used in the manufacturing shall be verified before

use. According to the operation to be carried out, environment

of the area should be controlled and monitored.

All required process controls shall be carried out as per master

formula record and shall be documented accurately.

Theoretical yield and actual yield at various stages of

production shall be compared. In the event of significant

variation at any stage, further processing should be stopped immediately and the matter should be investigated. In all

stages of processing adequate attention shall be paid to the

problem of cross-contamination.

All sections in the production area are well equipped with latest

modern machineries complies to cGMP norms.

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PRODUCTION

All the equipment's are made up of S.S 316. Parts

of the equipment, which come in direct contact

with the product, are non-reactive, non-additive

and non-absorptive.

New received equipment for production shall be

qualified before routine use.

All the equipment is being qualified in respect of

IQ, OQ & PQ.

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PRODUCTION [EQUIPEMENT]

PACKING

▪ Packaging operations shall be performed under strict controls.

Flow of materials, utilization of labors and materials and

packaging operation shall be carefully monitored.

▪ All the deliveries of packaging components received in packaging section are first verified for their correctness. Foils,

Labels, cartons and other components which require pre-coding

with batch number, manufacturing date and expiry date or any

other information are also carefully controlled till the labelling

and packaging operations are completed. The batch details on the labels, other packaging materials are recorded in the BPCR

by the production chemist and records are maintained properly.

▪ Prior to placement of materials on packaging line a line

clearance check by Q.A as stipulated in the SOPs. This shall be done to verify that all packaging materials used for the previous

batch have been removed from the packing line and area and

the equipment to be used have been properly cleaned.

QUALITY CONTROL

Quality Control Laboratory is

equipped with all required

instruments for Qualitative

and quantitative analysis of

raw materials, in process

control, finished Products.

QUALITY CONTROL

Functions of Quality Control Laboratory:

▪ Qualitative and Quantitative Analysis of Raw Material and packing material.

▪ Intermediate, bulk and finished product analysis.

▪ Calibration, verification of laboratory equipment.

▪ Analytical Method Validation.

▪ Stability studies analysis on finished product.

▪ Microbiological testing of raw material, finished product,

area Environmental monitoring, Purified water analysis.

▪ Periodic review of Retain sample for finished product &

raw material.

QUALITYASSURANCE

▪ Adequate facilities, trained personnel and

procedures are available for sampling,

inspecting and testing of starting materials,

packaging materials, and finished products.

▪ Exacting Quality Standards are upheld by a

team of experience scientists aided by modern

instruments and stringent technical review

systems.

▪ The sophisticated instrument like HPLC-LC 10

ATVP from Shimadzu Japan, allows for broad

analysis.

▪ The Ultraviolet-visible spectrophotometer ensures accurate analytical analysis. The

Dissolution Test Apparatus from Tab Machines

work on Timed released formulations.

QUALITYASSURANCE

▪ Shelf-life of products is evaluated, based on Long term and

Accelerated stability studies, with the help of Humidity control

ovens.

▪ A team comprised of qualified technical people from various disciplines and pharmacists are working towards the objective of

continual improvement in Quality of products in adherence to

the cGMP norms

▪ As a result of adopting an inbuilt system of continuous renewal and upgrading, factory is up-to date in terms of technology.

Premises are laid out in such a way to allow the production to

take place in areas connected in a logical order corresponding

to the sequence of the operations and to the requisite

cleanliness levels.

QUALITY POLICY

▪ AR LIFESCIENCES always aims to establish and maintain high standards of quality for its products.

▪ Products are manufactured and marketed in compliance

with regulatory standards related to identity, purity, safety

and efficacy through a well-defined quality assurance system.

▪ We ensure the quality of starting and packaging materials

by following Specifications & Standard Test Procedures.

The Quality Control Dept at our Associate Mfg plants is responsible for all sampling & analysis work related to raw

material, in-process and finished goods validation samples

& stability samples and aim at carrying out all

requirements of current Good Laboratory Practices

(cGLPs). We ensure that the incoming, in-process and final inspection is done as per documented procedures.

QUALITY POLICY

▪ AR LIFESCIENCES shall comply and constantly update with current national and international

Quality Protocols as applicable and continuously

strive for achieving global standards.

▪ Continuous training shall be given to the employees in the organization to enhance their skills in

performing their assigned tasks.

▪ We shall adjust and adapt to the changing needs of

our customers and remain dedicated in our efforts to serve them to the best of our ability.

DOCUMENTATION & DATA HANDLING

▪ Documents for product and process specifications

shall be formulated and maintained by QA

department, which includes broadly Raw Material

Specifications, Packaging Materials specifications,

Standard Testing Procedures etc.

▪ The records related to the manufacturing and

packing as well as for in-process checks and Q.C.

tests are filed together in Q.A. department.

▪ Supportive documents like microbiological quality of

air, water etc. and other like records of production

Q.C. & Q.A., utilities are maintained with the

respective departments.

▪ Following standard operating procedures carries out

the manufacturing and testing.

DOCUMENTATION & DATA HANDLING

▪ Standard operating procedures shall be prepared for process,

procedures, operation, cleaning, calibration, validation and all

activities related to the manufacturing operations.

▪ Computer program specifications:

All computerized documentation shall be Carried out by of

Pharmasuite Software.

▪ Validation documents:

Master validation plan and all validation shall be carryout asper standard Operating procedures and as per master plan

and schedule. All data are recorded in a desired format for

recording and related records are available and maintained.

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SELF INSPECTION

▪ Internal audit on all the systems, procedures and

operations shall be regularly conducted in order to

monitor compliance with and the effectiveness of GMP

and Q.A principles in various operations and to allow for

the improvement and corrective measures when required. Self-Inspection shall be performed at least

once in six months at properly spread out intervals. The

audit team shall be consisting of quality assurance,

quality control, production, engineering, store & dispatch

department.

THANK YOU