Presentation on

Presented by :
Md. Shaekh Forid
ID: 2015000300144
Batch : 25th (B)
INTRODUCTION
Sun Pharma at a glance
It is the 5th largest generic company in the world.
Largest Indian Multinational Company.
Established in 1983 by Dilip Shangvi with only 5 products.
Over 45 plants worldwide.
More than 900 R&D researchers.
Serves over 150 countries with over 2000 products.
Sun Pharma at a glance

Today, it is the largest chronic prescription company in

India and a market leader in psychiatry, neurology
cardiology, orthopedics, ophthalmology, gastroenterology
and nephrology.
Aims & Objectives of in plant training
For the development of our practical skills and techniques which
are directly applicable to our careers.

To realize and know how a pharmaceutical company runs.

To know how its departments are interlinked and work together.
To identify how GMP or cGMP is applied in the plant.
To have an idea about Standard Operating Procedure (SOPs).
Aims & Objectives of in plant training
To understand how pharmacists, manage the
manufacturing problems.
To see how quality is assured as well as controlled.
To learn about the documentation record practices.
To get the general ideas about corporate environment
and activities of an organization
Features of Sun Pharmaceuticals (Bangladesh) Ltd.
High quality products.

Documentation of every step.

Maintaining Batch Manufacturing Record (BMR) and Batch

Packaging Record (BPR).

Maintaining SOP (Standard Operational Procedure) strictly.

Maintaining required environmental conditions

(Temperature, %RH) in every room.

Strictly maintaining GMP/cGMP.

Standard QA activities.
Features of Sun Pharmaceuticals (Bangladesh) Ltd.

Standard QC analysis for each batch.

Strong and effective Internal audit.

Maintaining log Book for every Instrument.
Calibration of equipment is done as per SOP.

Implication of CAPA.
Controlled HVAC system.

Friendly environment.
 CNS disorders
Cardiology
Diabetes and Metabolic disorders
Gastroenterology
Products According
Ophthalmology
to Therapeutic Class Oncology
Pain
Allergy, Asthma and Inflammation
Gynecological
Some Drugs of Sun Pharmaceuticals (BD)

Brand Name API Therapeutic group Primary

Packaging

Sompraz Esomeprazole Magnessium Gastroenterology Blister

Tihydrate

Ursocol Ursodeoxycholic acid BP Gastroenterology Blister

Olmezest H Olmesartan Medoxomil INN Cardiology Strip

& Hydrochlorothiazide BP

Syndopa CR Levodopa BP and Neurology Strip

Carvidopa BP controlled
release

Gabantin Gabapentin USP Neurology Strip

Edegra Sildenafil Citrate Sex Stimulant Blister

Montek Monteleukast Sodium INN Anti-asthmatic Strip

Neugaba Pregabalin INN Psychiatry Strip

Departments of Sun Pharmaceuticals (BD)
Production Department (PD)

Warehouse Department

Packaging Department
In Process Quality Control Department (IPQC)
Quality Control Department (QC)
Quality Assurance Department (QA)
Product Development Department (PDD)
Maintenance Department
Production Planning & Inventory Control (PPIC)
Management Information System (MIS)
HR and Admin
Marketing Planning Department (MPD)
Layout of Sun Pharmaceuticals (BD)
Dosage forms of Sun Pharmaceuticals (BD)

Section of
Production

Solid Section

Tablet Capsule
PRODUCTION
DEPARTMENT
Production Department
Units of Production Department are-

Dispensing Unit

Granulation Unit

Compression Unit

Coating Unit

Encapsulation Unit
Dispensing:
The pouring or transferring of any material from a container,
tank or similar vessel, whereby vapors, dusts, fumes, mists,
or gases may be liberated to the atmosphere.
Dispensing
Granulation
Granules are prepared aggregates of powdered materials to
form a larger particle (2-4).

Types of Granulation

Direct
Wet Granulation Dry Granulation
Compression
Wet Granulation: The process of adding a liquid solution to powders
involves the massing of a mix of dry primary powder particles using a
granulating fluid.
Dry Granulation: This process is used to form granules without using a liquid solution,
because the product to be granulated may be sensitive to moisture and heat or does not
compress well.
Direct Compression
Equipments Used in Granulation
Compression Machine
Compression Machine Components
 Hopper: for holding and feeding granulation to be compressed.

 Dies: defines the size and shape of the tablet.

 Punches: for compressing the granulation within the dies.
 Cam tracks: for guiding the movement of the punches.

 Easy feeder/ force feeder: for moving granulation from the

hopper into the dies
Equipments Used in Tablet Compression
Compression Steps
Granules are poured in a hopper

Granules are filled into the dies by feeding mechanism

Upper punch lowers to compress the granules within the die cavity

Upper punch retracts and the lower punch rises to eject the tablet

Tablet is removed from the die surface by surface blade

The metal detector detects the metal from the tablet and eject the tablet consisting any metal
and at the same time the De-duster removes dust from the tablet.
Tablet Coating

Types of Coating

Enteric Coating Film Coating Sugar Coating

Coating Steps
Encapsulation
The Encapsulation is done by either
 Automatic Capsule Filling Machine

 Semi-automatic Capsule Filling Machine

Encapsulation Process by Automatic Capsule Filling Machine

For encapsulation of pellets the following procedure is done with the help of
Automatic Capsule Filling Machine in the capsule filling units of Sun
Pharmaceutical (Bangladesh) Ltd.

Blend Pellets with

Encapsulation
NPS
Powder Encapsulation

Blending

Slugging

Granulation

Seiving

Encapsulation
Flow Chart of Capsule Preparation
WAREHOUSE
Warehouse of Sun Pharmaceuticals (BD)
Types of Warehouse
There are 4 types of warehouse:

 Central warehouse.

 Infusion warehouse.

 Pharmatek warehouse.

 Track-2 warehouse.
Packaging

Types of Packaging

Primary Secondary Tertiary

QUALITY CONTROL
Areas of Central Warehouse
 Quarantine Area

 Released Area

 Dispensing Area

 Finished product Area

 Special Area

 Export Packaging Product Area

 QC sampling Room
Quality Control
A part of Quality Department that focuses on the fulfillment of quality requirements.
Aim & Objective of QC
 Improvement of quality
 Reduction of scrap and rework
 Efficient use of men and machines
 Economy in use of materials
 Removing production cost
 Scientific evaluation of quality and production
 Reduction in customer complaints
 To decide about the standard of quality of a product
 That is easily acceptable to the customer
 To check the variation during manufacturing
 To prevent the poor quality product reaching to customer
Quality Control Tests
Microbiology Tests
 Microbial Count of the purified water, FP, Raw materials, Hold time, SWAB test and
Stability test.
 Microbial test for finished products, like- E.coli count, P.aeruginosa etc.
 Microbial test of the room air.
 Monitoring the Environment of the Production area.
 Dispersed Oil Particulates (DOP) test for the filter.
 Calibration of equipment of microbiology lab.
Quality Control Tests
Finished Product Tests
 Description
 Identification
 Potency
 CU (Content Uniformity)
 Dissolution
 Disintegration
 Hardness & Thickness
 Weight Variation
 RS (Residual Substances)
 Friability etc.
 QUALITY
ASSURANCE
 Quality Assurance
 It is the totality of the arrangements made with the
object of ensuring that pharmaceutical products are of
the quality required for their intended use.

 QA is the heart and soul of quality control

 QA = QC + GMP /Other Quality Systems 
Aim & Objectives of Quality Assurance
 Increasing Customer satisfaction.

 Reduction of waste and increase production and enhance marketing.

 Improvement of employee motivation, awareness and moral.

 International trade promotion.

 Building communication of every aspect related to quality to all relevant persons.

 Maintaining validation master plan.

 Training the stuffs about GMP, SOP and CAPA to ensure quality products.
Functions of Quality Assurance
 Proper warehousing of incoming materials.
Search for non-compliance and corrective actions.
 Storage, manufacturing, packaging etc.steps
monitoring.
 Online documentation.
 Event/ Incident report.
 Internal Audit.
 Establishment and follow up of validation.
Functions of Quality Assurance
 Planed modification form.
 Training Arrangement.
 SOP preparation, review and controlling.
 Monitoring RMS, PMS activity.
 In case of new machineries there are some observations
that are recorded by QA are-
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
 Validation
• Validation is establishing documented evidence that provide a
high degree of assurance that a specific process, method or
system will consistently produce a result meeting its pre-
determined acceptance

Types of Process Validation

Process Analytical Equipment Cleaning Vendor

Prospective Retrospective Concurrent Revalidation

PRODUCT DEVELOPMENT
DEPARTMENT
Product Development Department
Functions of PDD

 Creation of an entirely new product or upgrading an existing

product by exploring all possibilities and outcomes.

 Innovation of a new or an existing product to deliver better and

enhanced services to end-users.

 Continuous improvement of a new product or enhancing an existing

product by giving preference to satisfy the demand of end-users.

MAINTENANCE
Maintenance
Maintenance department is a supportive service department in any
pharmaceutical industry, which exercises its activities and duties through
maintenance and repairing of the electrical and mechanical devices and other
facilities of the industry. They provide all sorts of engineering and technical
supports in the industry whenever necessary.

Objectives of Maintenance department:

1. Ensuring proper maintenance of equipment.

2. Providing smooth production.

3. Reduce maintenance cost.

4. Provide logistic support.
Functions of Maintenance
Maintenance of HVAC system.
Maintenance of chiller (water chiller).

Maintenance of production machineries.

Planning for yearly maintenance of production machineries.

Planning for yearly maintenance of utility (electricity, water supply etc).

Maintenance of vehicles.

Maintenance of facilities of the industry.

Repairing of equipment’s.

Engineering and technical support during installation of new equipment or

production machineries.

Support and service in purchasing instrument.

HR & ADMIN
Human Resources and Admin

Functions of HR and Admin

1. Human Resources Management.
2. Employee selection & recruitment.
3. Employee payroll & benefit monitoring.
4. Policy formation, implementation & monitoring.
5. Store, vehicle & security management.
6. Staff development & retain.
7. HR & admin budget & Implementation.
8. Prepare and arrange any in-plant training program.
9. Ensure labour-management security.
10. Supervise overall cleaning, transport, canteen and washing facilities of the plant.
Marketing planning
department
Marketing Planning Department

Duties and Responsibilities of MPD

Market research to understand various parameters to decide product range.
Formulation strategies for products.
Brand promotion plans.
Analysis of sales, profitability and revenue.
Contributing to research activities, conferences, seminars as well as publishing
new ideas.
Training about products to sales team.
Coordination with different suppliers.
Key points in Marketing

1. FAB Analysis (Feature, Advantage, Benefit)

2. SWOT Analysis (Strength, Weakness, Opportunity, Threat)

3. Brand

4. Demand Elasticity

5. Strategy

6. Brand Plan/Marketing Plan

Summery
Shortcomings of Sun Pharmaceuticals (BD)

1. Only Solid dosage form is manufactured.

2. Production area is small.

3. Production capacity is limited.

4. Lack of sufficient manpower.

5. The walls of production area are not appropriate for production.

6. Raw material storage conditions need to be developed.

7. Storage area is not sufficient.

8. Poor Canteen Facility.