Fast Pharma Private limited

FAST PHARMA PRIVATE LIMITED

COMPANY PROFILE

Address- Khasra No.-101,102, Salempur, Rajputana, Industrial area, Roorkee 247667

(Uttarakhand)


We Live for, What we Care for.

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BRIEF INFORMATION

GENERAL INFORMATION

FAST PHARMA PRIVATE LIMITED is a pharmaceutical formulation manufacturing private limited

company incorporated under the Indian companies Act-1956 on 30th Nov 2017 register office of the

company is situated at Delhi and manufacturing plant is in Roorkee, Uttarakhand, India. Fast Pharma

Private Limited was incorporated with an objective to manufacture and market pharmaceutical

formulations with different dosage forms and markets it in domestic as well as international market.

On the quality front company is facilitate with WHO GMP norms.

Fast Pharma Private Limited a WHO - GMP certified manufacturing facility in various dosage

forms. Our newly constructed formulations manufacturing facility is based in an area of measuring

9080 sq. mts approx., a kilometer from Roorkee – Dehradun highway in the state of Uttarakhand

India.

Management

FAST PHARMA PRIVATE LIMITED is managed by professionally qualified and well experienced

Managing directors. Mr. Sumit Mittal, Mrs Sangita Gupta and Mr. Shresth Gupta. Mr. Sumit Mittal

Managing Director of the company is always and all time available for company. He is M.Com. and he

has more than 15 years of managerial and administerial experience. Mrs. Sangita Gupta has master’s

degree (post-graduate) in professional qualification and having more than 13 years in managing and

administerial experience. Mr. Shresth Gupta is the youngest Director and has completed his Bachelor’s

in Business Administration, Master’s in Business Administration (Finance) from India and MSc

International Business from United Kingdom.

Our production, QC and QA departments are in hands of vastly experienced and well qualified managers

& staff capable of delivering the most advanced formulations with highest standards of quality. Our

marketing team consists of MBAs and managers having international education and experience to take

care of our associates at every stage of business.

LOCATION

Manufacturing unit and Administrative Office is in main town in Roorkee approx. 1 km from Roorkee-

Dehradun National Highway. Fast Pharma Private limited is just 165 kms from national capital New

Delhi. Nearest Airport is at Dehradun, 50 Kms. from the plant. Nearest Railway Station of Roorkee is 3



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Kms. from the plant and Nearest bus stand (Roadways) of Roorkee is 4 km from the plant which is easily

approachable.

VISION AND MISSION

MISSION

Our Mission is to be one of the fastest emerging well-known company in Indian Pharmaceutical Industry

& capture significant market share all over India

We committed to providing the Indian pharmaceuticals Companies with the finest quality products with

best price and to lead the Industry In The Identification and Formulation of The Unique, Conceptual,

Evidence based Drug

Our concentration is to upgrade the elements of our customer’s association to meet the necessities of

affirmation standards.

VISION STATEMENT

Our vision is to be Global Pharmaceutical Company by providing healthy and quality life through quality

products & Services. and to be a leading Pharmaceutical industry in India by providing innovative and

effective product concept addressing the major human health care concerns.

We are determined to accomplish our vision by working intimately with our clients.



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INFRASTRUCTURE

FACILITIES AND CAPABILITIES

Manufacturing Unit at Roorkee is designed and equipped to deliver standard quality drugs on time with

flexibility of batch sizes. We have the know-how and technical capability to manufacture more than 100

different stable formulations for human and animal use.

Fast Pharma Pvt Ltd. is spread over 9000 Sq. Mts. of land has double storied built up production area.

3054 sq. mts. for liquid injection, 1341 sq. mts. For liquid oral and ointment and 1140 sq. mts. For

Quality control and microbiology area.

Manufacturing area is divided into three separate building blocks of Injection building blocks, Liquid oral

and Ointment building block and Quality control and Microbiology block, having ability to manufacture

comprehensive dosage formulations as under.

Dosage Form Capacity

Liquid Injections 15 million units per month - Ampoules upto 10 mL

External

Preparations 2 million units per month – Ointments, Lotions and Gels in Lemi Tubes.

Oral Liquid

Section

3 million units per month – Syrups and suspensions in PET and glass bottles from

10 ml. to 1000 ml

AUTHORIZED PHARMACEUTICAL MANUFACTURING ACTIVITIES

Fast Pharma Private Limited have the Drug Manufacturing License No. 31/UA/2019 in form 25 and

31/UA/SC/P-2019 in form 28 valid up to 28/06/2024 issued from the Drugs Controller, Directorate

General of Medical & Health Sahstradhara Road, Dehradun, Uttarakhand India. All the Manufacturing

activities are carried out as per Schedule –M of the Indian Drugs & Cosmetics Act and Regulatory

Activities are control by The Drugs Controller, Directorate General of Medical & Health Sahstradhara

Road, Dehradun, Uttarakhand India.



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PLANT & MACHINERY

PREMISES

Premises have been designed, keeping WHO-GMP, Safety and Manufacturing Capacity in consideration.

Premises and Equipment are located, Designed, Constructed, adapted and maintained to suit the operation

to be carried out. Their layout and design are in such a way that it is aimed to minimize the risk of errors

and permit effective cleaning and maintenance in order to avoid cross contamination, any adverse effect

on the Quality of Products. The Premises’ used for Manufacturing, Processing, Labeling, Testing and

Storage purposes are well maintained and adequate to allow orderly and logical placement of Equipment

and Materials

HVAC SYSTEM

The facility is designed to avoid cross contamination & for smooth functioning of manufacturing

activities (Ground and First Floor). Systems are designed according to the required characteristics of the

environment of cleanliness level in order to minimize the risks of particulate or microbial contamination.

Appropriate ventilation arrangements are provided in the factory, The corridor also environmentally

controlled to prevent any ingress of air / powder from each room to the corridor (maintain positive

pressure / negative pressure as per requirement), All work stations are covered with suitable HVAC (Heat

Ventilation air conditioning) system with independent AHU (Air Handling Unit) where required to avoid

remote chances of cross contamination, each AHU unit of production area is equipped with graded

filtration system consisting 10 micron filter at exhaust point, fine filter of 5 Micron & 0.3 micron HEPA

filter at air supply and a pre filter of 10 micron at the entry from where fresh air is drawn. Integrity of

sterile area is taken care by HVAC systems. Appropriate LAFs in sampling, dispensing, sterile production

and microbiological testing lab are installed.

WATER SYSTEM:

Purified Water: There is bore well as a source of raw water. The purified water storage tanks are

constructed of SS 316 L quality. Purified water produced is supplied to all user points, through

continuous circulation loop system. All closed loop materials are of SS 316 L quality. Zero Dead leg

valves and sampling valves are provided where required.



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The purified water is collected in SS storage tanks. The purified water is passed through UV radiation

before it is entered in the Loop line.

WFI Generation System: Purified water also connects to the Multicolumn water treatment plant to

preparation of Water for Injection. WFI is stored in 500 Liters SS 316 L jacketed tank. All Purified water

& Water for Injection are circulated in the plant through the LOOP SYSTEM made up of 316 L Pipelines.

BRIEF DESCRIPTION OF OTHER RELEVANT UTILITIES

Electricity: 800 KVA sanction load of electricity is supplied by semi-government corporation UPCL. In

addition to this electricity generator is installed at site (500 KVA) for regularity of power supply. Servo

voltage stabilizer protects all installations from voltage fluctuations. Control panels at service floor are

point of control and distribution of power. All wiring in production areas is concealed. Whole system

meets safety norms of the state.

Compressed Air: Three air compressors having oil, water and air filters are installed at service floor to

meet needs of compressed air.

Effluent Treatment: Wastewater generated during process of production is subjected to ETP plant.

Final water for discharge meets acceptable limits as specified by the state pollution control authority. By

installing air scrubbers at every air discharge point suspended particles are removed before releasing air in

the atmosphere.

Description of Major Equipment’s

Product contact parts of all Equipment’s of Manufacturing & Processing Department are made of

stainless steel 316 type. The equipment’s are designed that facilitate ease of cleaning. Modern

equipment’s are procured and installed for all the department as per WHO norms.



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QUALITY SYSTEM

We believe that quality is soul of Pharmaceutical Formulation Company. Aim of quality system is to

ensure that standard quality products are manufactured in quality environment using standard processes

and materials. To achieve this goal comprehensive quality system is implemented whereby each and

every material, process, procedure and activity is standardized, validated & documented. Quality

Assurance and Quality Control departments are heart of our quality system.

The site operates in accordance with WHO-GMP Standards. The Quality System involves the

integration of all functions on the site to achieve the legal, contractual, standards and company

requirements.

A fully documented quality system is established and maintained which ensures that products and

services that are bought, produced, released and sold meet the specified requirements of the relevant

specifications and ultimately the requirements of the manufacturing license.

Senior Management Reviews are held and documented, and they use Internal Audit results,

deviations, CAPA’s, external audits and Annual Product Reviews to determine the effectiveness of the

quality system. Weaknesses and deviations are discussed, and actions are initiated accordingly.

The purpose of the Quality Management System is to ensure compliance of WHO-GMP requirements as

enforced by National and International Regulatory Bodies. The Quality Management System ensure that

all activities related to manufacturing of Drug Products in compliance with WHO-GMP are controlled by

Standard Operating Procedures, So that the end product meets all the Predefined Specifications ensuring

the Strength, Safety & Purity of the Products.



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QMS PROCESS MAP Resources Resources

P R O D U C T R E

A Resource Needs

L I Policies & Direction Z A T I O N P Policies & Direction

R O QMS Performance

C

E

S S

(PRP) Product Process Data

Customer

Sales &

Order

Processing

Purchasing

Receiving

Inventory

Management

Production

Inspection,

Test & Methodology

Delivery

Production

and quality

Planning

Product

Design

Customer

Resource Management Processes (RMP)

Information, Doc.

Control & Inf. Tech

Personnel

Competence

and Skills

Facilities,

Equipment &Work Environment

Management Responsibility Processes (MRP)

Planning &

objectives

Management

Review

Measurement, Analysis

and Improvement Processes (MIP)

Control of

NC Product

Int. Audit &

Analysis of

Data

C&P Action

Customer

Complaints/Satisfaction

Continual

Improvem

ent



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QUALITY POLICY

Fast Pharma is committed to manufacture and market ‘Quality’ products which are meeting with

predetermined specification and are ‘safe’, ‘effective’ and ‘acceptable’ throughout shelf-life”. This can

only be achieved by ensuring implementation of current Good Manufacturing Practices, Good Laboratory

Practices, Good Documentation Practices, and Monitoring of Stability of the products and improvement

of processes and systems through validation. Quality Innovation and Service are the key words in Fast

Pharma and the company joins hands with the employees to achieve them.

VALIDATION

Critical equipment’s and processes are validated. Whenever any new process / facility / system are

developed or any new equipment is installed, the same undergoes Design Qualification (DQ) Installation

Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as per the

requirement of the particular equipment/ process.

CALIBRATION POLICY

All instruments are calibrated and will be calibrated according to their schedule of calibration. Proper

calibration is done as per their respective SOPs and records are maintained for the purpose.

AUDIT PROGRAMMES

All Departments will be audited internally for WHO-GMP Compliance. The audit is conducted by a team

comprising of competent persons from different departments, other than the one to be audited.

The audit will be carried out as per SOP for Self –Inspection & Audit Reports recorded in a defined

format.

QUALITY EFFICACY AND SAFETY OF THE PRODUCTS

We ensure the Quality Efficacy and Safety by necessary controls on starting materials Intermediates and

Finished Products. All manufacturing process are clearly defined systematically reviewed meeting the

quality that comply with their specifications and by maintaining proper Storage Condition at all the

manufacturing steps.



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DISTRIBUTION, COMPLIANT & PRODUCT RECALL

Released finished goods are stored in a fully secured finished goods store. The system of distribution

records is maintained in such a way that traceability of the product history is ensured Products

manufactured by Fast Pharma are distributed in domestic market throughout the country. In India goods

are dispatched through road or rail. Goods are dispatched in India only to those customers having valid

wholesale drug license. Copy of such license is obtained and kept in record beforehand. Products are

packed in transport worthy shippers and are labeled. Temperature sensitive products are labeled “Store

below 25 0C” and appropriate transporter is chosen for the same.

Dispatch slip and invoice is prepared depicting unique batch number, brand name and quantity

dispatched. Each shipper is also labeled with brand name, batch number and quantity in that shipper.

Thus, each product can be tracked and traced.

There is a well-defined procedure for handling of market complaints and product recall. Complaints are

received, investigated and rectified by quality assurance department. If there is any problem quality

assurance instructed to recall the material from market. If any defect is noticed on self-examination of

control sample then also product is recalled.



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CONTRACT MANUFACTURING & ANALYSIS

CONTRACT MANUFACTURING

In case of a business opportunity the company policy permits contract (loan license and third party)

manufacturing activity.

For analysis occasionally, we use services of approved public testing laboratories. However, the final

batch release is the authority of our Quality Assurance, after review and audit of batch production, batch

packing and analysis record. Contract manufacturing (P to P / 3rd Party manufacturing) is one of the

major services offered by Fast Pharma Private Limited. We have applied for manufacture over 300

different formulations in Liquid parental, Liquid oral and Ointment dosage.

We are committed for

• Formulating customized product size, shape, colour, taste, and packaging as per requirement of customer

and their market.

• High efficacy formulations comparable to brand leaders meeting pharmacopeia and prescribed drug

standards.

• Critical products with assured stability throughout the shelf life.

Timely supplies without botheration of follow ups.

• Large as well as small size batch sizes as per need of customer

Our manufacturing Product Formulation List provides all the details of products formulation which we

applied and currently offer for contract manufacturing.

Please feel free for contacting us for new product development even if not listed in our current

product formulation list.



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CLIENTS

Our esteemed clients are:

• Leeford Healthcare Ltd

• Zydus Cadila Healthcare

• Lincoln Pharmaceuticals

• Cresent Lifesciences Pvt Ltd

• Cenofi Healthcare Pvt Ltd

• Emblazon Lifesciences Pvt Ltd

• Alvita Pharma (Export)

• Saviour Pharmaceuticals (Export)

• Klintoz Pharmaceuticals Pvt Ltd. (Export)

• Everva Lifecare (Export)

• Pharmall Care, Yemen (Export)



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CONTACT

CONTACT INFORMATION

Name and Address of the Site, Including Telephone, Mail and 24 hrs Telephone Number

Registered Office H.No.-13, PVT-13/1, KH.No. 262/258/217/4/3, 1st Floor, Bunglow Road,

Block-C, Adarsh Nagar, Delhi 110033

Manufacturing Unit Khasra No.-101/102, Salempur Rajputana, Industrial area, Roorkee, Haridwar –

247667 (Uttarakhand)

Telephone / E mail No. of Contact Person

Plant

Phone +91 9084738373

Emergency +91 9258042742

E-mail [email protected]

Contact Person Mr. Shresth Gupta / Mr. Sumit Mittal

Documents

Fast Pharma Private limited