PHARMACEUTICAL REPACKAGING

FACILITY PROJECT REPORT

Project Report
On

Pharmaceutical Solid Oral Dosage

form Re-Packing Facility

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FACILITY PROJECT REPORT

EXECUTIVE SUMMARY

Company Name
Baader Schulz Laboratories........

Administrative Office
Shantivilla, Shantivan Tower Compound
Devidas Lane, Borivali (West)
Mumbai – 400103, INDIA
Telephone : +91-22-28956139 / 28956142 / 28940565 / 28918746 / 28900989

Nature of Activity Manufacturers of Pharmaceuticals

Proposed Project Repackaging of Pharmaceuticals Solid oral

dosage forms

 Tablets
 Capsules

Promoters Mr. Nailesh Shah

Mr. Kirtilal Shah
Mr. Kalpesh Shah

Present Directors Mr. Nailesh Shah

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INTRODUCTION

BAADER SCHULZ LABORATORIES is a Pharmaceuticals manufacturing formulating

unit started by young dynamic business entrepreneurs having more than 20 years
experience in this field.

In the year 1996, it planned and executed a state of the art plant in Daman (India) for the
manufacture of Animal Health, like Growth Promoters, Electrolytes, Enzymes, Toxin
Binders, Coccidiostats, Vitamins Premixes, Liquid, Powder and Bolus & Animal feed
supplements & Veterinary Formulations for poultry and animals.

After achieving great success in veterinary field, both in the domestic and export markets,
the company has further set up a new Manufacturing facility in the year 2003 - 2004 with
consideration of WHO-GMP norms under banner of Baader Schulz Laboratories –
Unit-2.

Through this Project, the Company proposes to commission a Repackaging facility for
Solid oral Pharmaceutical dosage forms in Srilanka. The company has a WHO GMP
Approved Manufacturing facility at DAMAN in INDIA and the Semi finished
Pharmaceutical dosage forms shall be supplied in Bulk packing suitable to ensure the
Quality, Safety & Efficacy of the Drug Product and shall be repacked in the Proposed
Repackaging facility.

Growth Drivers
- Increased risk of population vulnerable to diseases.
- Increasing demand of Drug products at affordable prices in ASEAN market

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Vision
To be a globally respected Pharmaceuticals company with increasing focus on innovative
research of development of products to make the difference.

Mission

 Achieve Market Leadership in Healthcare Products,

 Cater to Export Markets with Quality & Competitively priced products
 Employ State – of – the – Art Manufacturing Technologies
 Build Strong Customer – relationships

BUSINESS GOALS & OBJECTIVES

1. To launch & install a Green field project for the repackaging of Pharmaceutical Drug
Products. The dosage forms shall be :

a. Tablets
b. Capsules

2. Facility in compliance with WHO GMP, Government of Srilanka rules & regulations
for the repackaging of Pharmaceutical Products.

3. The products shall be repacked and distributed from this unit for Sale.

4. Target markets are Srilanka & neighbouring countries.

BUSINESS STRATEGY
a. Repackaging of Drug Products.

b. Distribution of Finished Drug Products from this facility to Srilanka & neighbouring
states, through Marketing Associates.

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BUSINESS COMPETITIVENESS
Resource Competitiveness:
The Company has the expertise of the knowledge of the production process and equipments
for the manufacturing & processing of the Pharmaceuticals dosage forms.

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COMPANY’S PHILOSOPHY OF QUALITY ASSURANCE SYSTEMS

Quality Policy:

We value our relationship with our customers and are committed to provide them the best
quality Products with timely deliveries.
Continuous improvements and Customer satisfaction is our aim.

The Quality Systems are supported by adequately resourced competent Personnel, Equipment
and Facilities.

The Quality systems are based on WHO GMP & ISO standards. The QA systems have been
implemented through trainings.

Quality Assurance Systems

Responsibility of Quality Unit

♦ Quality unit is responsible for designing, implementation and monitoring of quality

systems.

♦ Develop specifications and analytical testing procedures to assure that the final
product meets all the customer and regulatory requirements.

♦ Approve or reject all raw materials, in-process materials, finished products, containers,
components and packaging materials.

♦ Review of production and analytical records for correction & completion and
investigation of deviations, if any.

♦ Review all SOPs, manufacturing procedures and validation records.

♦ Releasing of all finished goods for the market and handling of customer complaints.

♦ Recommending and developing effective quality control systems for all the products
manufactured by the company.

♦ Storage and control of all master documents, analytical testing procedures completed batch
records and analytical records.

♦ Implementation of training programs for GLP & GMP for the whole organization.

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♦ Co-ordination with the manufacturing departments in controlling the processes to

meet the set specifications of quality through product testing, auditing and reporting.

♦ Internal audits to ensure the effective adherence of Quality Systems across the
organization and that the finished products are manufactured and tested in compliance
with cGMP, Master Manufacturing Formula and in conformance with Approved Product
Specifications and packed as per the approved packaging components. Also to propose
necessary corrective measures, if required. Frequency for internal audits will be once in six
months for every department.

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QUALITY SYSTEMS
For the Repackaging facility, we have plans to design the Quality systems based on the WHO
GMP & ISO 9001:2008. Thus we will be at par with the International Quality Management
systems.
Quality systems will be implemented through preparation of Standard Operating Procedures
(SOPs), through trainings from experts. Facility, equipments, utilities shall be qualified before
taking into operations. A Master Validation Plan will cover all the Qualification and
Validation Policy of the company. Effectiveness of the Quality systems will be ensured
through Regular audits by a Cross Functional Team

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MARKET & MARKETING PLAN

The Company plans to market the products for domestic & other markets outside Srilanka.
To run the plant to the optimum installed capacity the company needs to work on distributing
the product in the domestic market through local distribution channels as well as has plans to
export the products to various neighbouring countries.
Our long term plans include the supply of Finished Pharmaceuticals to the Semi regulated
markets. We foresee good opportunities therefore we expect good business and facility
utilisation to the optimum installed Capacities in the short span of time.
With a good network of customers and the good manufacturing facility we have plans to add
good customer base. This activity will be co-ordinated by the business development group of
the company. Supply chain management will ensure the timely availability of required input
materials and timely deliveries to the customers.
To support the Exports the company has a team of regulatory professionals who understand the
registration requirements of the products in various countries. And can compile the product
dossiers in line with the requirements.
The Company plans to launch the products under the following segments:

Dosage Form Segment

Tablets General
Betalactam & Cephalosporins
Capsules General
Betalactam & Cephalosporins

The products shall be packed in various packings,

a. Alu-Alu blister
b. Alu-Alu strip
c. Alu-PVC/PVDC Blister
d. Bulk packing in Containers

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PROJECT IMPLEMENTATION

Project implementation planning is given below. The total project will require approximately
12 months for completion. The operations will start within two to three months from the
completion with due qualifications and validations.

Utilities required
a. Power Generators
b. Compressed Air
c. Nitrogen

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PLANNED CAPACITY
The proposed capacity of the facility, in terms of the maximum rated output of individual
dosage forms is planned as below :

Dosage Form Installed Capacity/Day(2 Shifts)

Alu-PVC Blister 9.0 Crore
Alu-Alu Pack 11 Crore
Strip Pack 2.0 Crore
Bulk Pack 7.0 Crore
TOTAL 29 Crore

*It includes the Dosage forms under Tablets/Capsules considering, General &
Betalactam/Cephalosporins.

Below table gives the break up of the dosage forms under different categories.

Quantity in Crores
Category Tablets Capsules Packing
General 5 5 Alu-PVC/PVDC
Betalactam/Cephalosporins 3 3

General 5 5 Alu-Alu Blister

Betalactam/Cephalosporins 3 3

General 3 3 Alu-Alu Strip

Betalactam/Cephalosporins 2 2

General 5 5 Bulk Packing in

containers
Betalactam/Cephalosporins 3 3
29 29

*Tablets & Capsules capacity is considered on staggered packaging operations. Thus the
facility can taken up 29 Crore units in a month, considering two shift of production.

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COMPONENTS IN THE FACILITY

Proposed area for manufacturing site is approximately 48,000 square feet. The building
comprises of the following areas.

S. No. Area
1 Administrative Area
2 Quality Assurance & Quality Control
3 Warehouse
A. Primary Packing material area
B. Secondary Packgin material area
C. Tertiary Packing material area
D. Rejected Packing material area
4 Semi Finished Goods Area
A. Tablets and capsules Bulk pack (Approved & Undertest)
B. Rejected Tablets & Capsule Storage Area
5 Packing Area
Area for Primary, Secondary packing considering 3 lines of “Alu-Alu, Alu-
PVC, Strip packing & Bulk Packing”
6 Finished Goods Storage area
7 Utility Area
8 Security Block

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The Facility has been planned to comply any international GMP standards. As it is a Greenfield
project adequately big areas have been planned for different activities considering operational
convenience. Manufacturing process flow & Packing Lines have been planned with required
automation to minimize the intervention of personal and the product. This will ensure the
safety of the product as well as minimize any errors which are possible due to manual
operations.

To support the manufacturing operations following utilities have been planned:

1. Compressed Air
2. DG Set to ensure uninterrupted power supply.

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PROCESSES FLOW DIAGRAM

Semi finished Bulk

Testing of Semi
Finished Bulk

QC Release

Packing

Alu-Alu Blister Alu-Alu Strip Alu-PVC Blister Bulk Container

Filter

Finished Goods Testing

Inspection and
Release by QA

Release to Finished Goods Store

Dispatch

There will be separate Blocks to cater General, Betalactams & Cephalosporins manufacturing
activities with separate HVACs.

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PROJECT COST

AREA REQUIREMENT

Total Required area for the project is approximately 48000 sq. ft.in a broader sense. Break
down of which is as follows: (Minor details of sub-sections in each area are provided in the
Section subsequent to this.

Area Measurement
Packing Material Store
Primary Packing Material Area 35 x 35 = 1225 sq. ft.
Secondary Packing Material Area 50 x 50 = 2500 sq. ft.
Tertiary Packing Material Area 50 x 50 = 2500 sq.ft.
Rejected Packing Material Storage Area 15 x 15 = 625 sq. ft.
Semi Finished Goods Store
Tablets and capsules Bulk pack (Approved & Undertest) 80 x 80 = 6400 sq.ft.
Rejected Tablets & Capsule Storage Area 15 x 15 = 225 sq.ft.
PACKING AREA
Area for Primary, Secondary packing considering 3 lines 60 x 60 mts. =
of “Alu-Alu, Alu-PVC, Strip packing & Bulk Packing” 3600 sq.mt=
12000 sq.ft.
For two blocks it
will double to
24000 sq.ft.
FINISHED GOODS STORAGE 25 x 25 mts. = 625
sq.mt =2050 sq.ft
Quality Control & Quality Assurance Area 80 x 80 ft. = 6400
sq.ft
Administrative Area & Security Block 1000 sq.ft.
Utility Area 1000 sq.ft
TOTAL AREA 47925 sq. Ft.

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CONSTRUCTION COST

Area Rate Total Cost

Warehouse* 15525 sq.ft. @ INR 1000.00 1.55 Cr.
Core area (packing)** 24000 sq.ft. @ INR 2000.00 4.80 Cr.
Quality Control, Quality 8400 sq.ft. @ INR 1600.00 1.34 Cr.
Assurance, Administrative,
Utility areas
TOTAL COST OF CONST. INR 7.69 Cr.
*Warehouse consutruction shall be different to the other Plant premises, hence the
cost is different. Cost includes the racks and other utilities.
**Cost of equipments is separate. It includes lighting, flooring, ducting.

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PLANT MACHINERY
The list of Major machinery and equipment required are presented in below table. The total
estimated cost of the machinery and equipment is about INR 3.80Cr.

NAME OF QUANTITY COST (In INR)

MACHINE
ALU-PVC Blister Machine 3 15 L + 12L + 50L
(Machine cost + Camera +
Cartonator )
= 0.98 Cr. Per Line

ALU-ALU Blister Machine 3 50 L + 12L + 50L

(Machine cost + Camera +
Cartonator )
= 1.4 Cr. Per Line

STRIP Packing 3 5 L + 12L + Optional

Machine (Machine cost + Camera +
Cartonator-optional )
= 0.22 Cr. Per Line

BULK Packing 3 70 L with counter and capping

Machine only;
= 0.90 Cr. Per Line

Blender 1Kg 2 0.40 Cr

TOTAL* 3.90 Cr.
*The Equipment cost is considering Phase 1 equipments.

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QUALITY CONTROL INSTRUMENTS COST

Area Rate Total Cost

6 HPLCs 0.30 Per system 1.80 Cr.
2 GCs 0.22 Per system 0.44 Cr.
FTIR 0.14 Cr. 0.14 Cr.
Other Instruments 0.50 Cr. 0.50 Cr.
TOTAL COST OF CONST. INR 2.88 Cr.

UTILITIES
Utilities requirements for the planned capacity have been worked out and are given below:

Equipment Total Cost

DG Set 500 KVA 0.50 Cr.
AHUs (20 units)* 0.12 Cr.per AHU 2.4 Cr.
Compressed Air (200 CFM), 0.14 Cr 0.14 Cr.
Oil free
TOTAL COST OF CONST. INR 3.04 Cr.
Considering the load of 120000 KW per month, power requirements have been worked out.
*20 units of AHU considered based on AHUs in two blocks.

TOTAL COST

Equipment Total Cost

Construction cost 7.69 Cr.
Plant Equipment cost 3.90 Cr.
QC 2.88 Cr.
Utilities 3.04 Cr.
TOTAL COST OF CONST. INR 17.51 Cr.

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Details of Area Utilization will be as under:

Part-I: Semi Finished Bulk Stores

a. Material receiving bay

b. De-dusting area
c. Quarantine area for Under-Test materials
d. Rejected material area
e. Sampling Booth
f. Dispensing area
g. Approved material area
h. Capsules shells storage area
i. Stores Office

Part 2 – Packing Material Store

a. Material receiving bay

b. Under-test Primary-Packing Store,
c. Under-Test Secondary Packing Material Store
d. Approved Primary Packing Store
e. Approved Secondary Packing material store
f. Sampling Booth
g. Dispensing area
h. Rejected Packing material area
i. Tertiary Packing material area

Part-3: Blending Area

For Capsules

Part-4: Primary Packing Area

a. Day Store for Foils & Laminates

b. Day store for dispensed Semi finished bulk
c. Genetor room
d. Change part/Ancilliary room
e. Primary packing area – Alu-Alu blister machine 3 units, Alu-Alu strip machines 3, Alu-
PVC/PVDC Blister machines 3 and Container filling machines area
f. Work in Process quarantine
g. Genetor Room
h. Washing Area
i. Scrap disposal area
j. Production office

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Part-5: Primary Packing Area

a. Packing Lines – 5Nos

b. Area to keep WIP Goods,
c. Production Office.

Part-6 Finished Goods Storage Area:

a. Under-Test Finished Goods Storage Area,

b. Released Finished Goods Storage Area,
c. Airlock for the dispatch of Finished Goods
d. Loading Bay for Dispatch.

Part-7 Quality Assurance Department

a. In-Process QA Room, QA Office

b. Room for Head Quality Assurance
c. Record Room
d. Retain Sample Room

Part-8 Quality Control Department

a. Chemical Lab
b. Instrument Lab (HPLC, GC, RoomS)
c. Hot Zone
d. Chemical Storage Room,
e. Stability Chambers Area
f. QC Staff Room
g. Microbiology Section,
h. Glass-ware Washing Area
i. Glass-wares Storage Area
j. Record Room

Part-9 Man Entry

a. Change Room for gents & Ladies (Worker)- One number each,
b. Change Room for Gents & Ladies (Staff)- One number each,
c. Change Room for the entry in store area,
d. Airlock to enter in Manufacturing Area
e. Airlock to enter in Primary Packaging area
f. Change Rooms at QC Lab
g. Airlock to enter in Dispensing area
h. Airlock for entry in Sampling Booth Area
i. Airlock for the entry in Microbiology Section
j. Linen Room.

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Part –10 Engineering & Maintenance

a. Engineering Office
b. Workshop
c. Store.

Part-11 Utilities

a. Distribution Transformer
b. Service Floor
c. Air Compressor Room
d. DG Set Room.
e. Control Panel Room

Part-12 Security & Time Office

a. Security Room
b. Time Office
c. Visitors Meeting Room
d. Drivers Room.

Part-13 Admin Block

a. Accounts Office
b. Cashier Room
c. Plant Head Room,
d. Meeting/Conference Hall
e. IT Room
f. Purchase/Supply Chain Office
g. HR Office
h. Reception, Pantry

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