INDUSTRIAL GUIDE : BALDEV THAKUR

ACADEMIC GUIDE : Dr. SATEESH BELEMNKAR

PRESENTED BY : ASHISH GOSWAMI (B079)

(B.PHARM + MBA 4TH YEAR)

SPTM,NMIMS,SHIRPUR

Industrial Training

In

Macloeds Pharmaceutical

INTRODUCTION

OVERVIEW

WAREHOUSE

CONTENTS

CONCLUSION

PRODUCTION DEPARTMENT

INTRODUCTION

• VISION AND MISSION To provide affordable drugs for essential therapies like TB, malaria & HIV. To continue to have the 1st mover advantage in the domestic market in various

therapeutic segments. To be a strong vertically integrated global generic manufacturer.

• Incorporated

1986

• Office Adresss

Macleod's Pharmaceuticals Limited

Atlanta Arcade, Marol Church Road, Andheri (East),

Mumbai - 400059, INDIA.

• PRESIDENT: Rajesh Kabu

• Website

http://www.macleodspharma.com

• Listing

Equity Shares: BSE Limited and National Stock Exchange of India Limited 

Global Depository Receipts: Luxembourg Stock Exchange

• Turnover*

Rs. 5.5 billion

• Employees*

5001-10,000 employees (INDIA)

WAREHOUSING

Warehouse person will make a GRN(GOODS RECEIPT NOTE CHECKLIST).

Further it will inform Q.C for sampling through Q.A and by entry on IMS.

Sampling done by using sampling formula.(√n+1) For API 100% Sampling.

Sample label are prepared by Q.A in order to avoid any mismatch and identification

of product.

Testing of samples done by Q.C.by various techniques involved.

Samples tested and found under certain specifications are classified as

approved.and those which are not under specification are classified as rejected

materials.

Production sends requition to warehouses for approved batches required to

undergo further production and convert to a final product.

• Macloed’s Pharmaceitucals has its own warehousing and storage facility located at: Kharuni - Vill Theda, Lodimajra Road, Baddi, Solan - 173205 .(Pharmaceutical Industrial) area

PRODUCTION DEPARTMENT

• It offers dispersible, bi-layered, coated, uncoated, and enteric coated tablets; hard and soft gelatin capsules; dry powder injections and syrups; and granules and liquid orals.

• The company provides products in various therapeutic groups, such as anti-infective, cardio-vascular, CNS, respiratory inhalation, dermatology, oncology, and orthopedics; and anti-TB, asthma and COPD, anti bacterial, NSAIDS, malaria, HIV, anti-arthritic, anti-osteoporotic, gastroenterology, gynecology, diabetology, and CVS.

• Macleod's Pharmaceuticals Limited was founded in 1986 and is based in Mumbai, India. It also has presence in South East Asia, the Asia Pacific, Africa, North America, EU and EEA, MENA, Latin America, and CIS countries.

• At, Baddi Anti-Tuberculotic and Anti-histaminic drugs are being produce

• Anti-Tubercular drugs namely are;

Generic Name

Strength Dosage

Anti-Tubercular Drugs

1 Generic Name

Strength Dosage

2 Ethambutol

100/200/400/600/1000 mg

Tablets

3 Ethambutol + Isoniazid

800 mg+300 mg

Tablets

4 Ethionamide

125 mg/250 mg

Tablets

5 Isoniazid 100 mg Dispersible Tablets

6 Isoniazid 300 mg Tablets

7 Kanamycin

0.5/1 gm Injection

8 PAS Sodium 1 gm / 0.5 gm Tablets

9 Prothionamide 250 mg Tablets

10 Rifampicin + Isoniazid + Pyrizinamide

100 mg+50mg+300 mg/60 mg+30 mg+150mg

Dispersible Tablets

11 Sodium Aminosalicylate 60% w/w granules (MONOPAS)

60 %w/w Sustained Release Granules

Sr # Generic Name Strength Dosage

Anti-histaminic

1 Azelastine + Fluticasone

140 mcg+ 50 mcg

Nasal Spray

2

Diphenhydramine HCl+Ammonium Chloride+Sodium Citrate+Menthol

13.5mg+131.5mg+55mg+1mg

3 Fexofenadine 120/180 mg Tablets

4 Loratadine 10 mg Tablets

TabletTablets are defined as unit dose, temper evident solid preparations each containing one or more active ingredients and obtained by compressing uniform volumes of particles.

•They are mainly intended for oral administration.

•The chemical, physical and microbiological stability of • tablet dosage forms is superior to other dosage forms.

•Tablets are generally an inexpensive dosage form .

Machine used In Tablet Granulation

• Mixing (Saizoner Mixer) :- Saizoner Mixer• Saizner Mixer Granulator is designed to meet special needs of

tablet manufacturing technology. This is achieved by reducing processing time, more homogenous mixing, Uniformity of Granule size and above all maintaining improved hygiene compliant to cGMP norm.

• CONSIST OF :1)GRANULATOR: The Granulator rotates at two speeds – 1500 / 3000 RPM. The Granulator head is of highly polished stainless steel and is easily

removable for cleaning.

• Capacity : 1000 litre• Time of Running : 1 hour (approx)• UTILITY: Assist blending of powder and to

assist blending of powder and to break the product to granules of required size.

• Shifter :- • It is used to separate desirable fine granules from the coarser

granules by using a vibrating sieve of different numbers.• Parts of Shifter-

Hopper

Vibrating Sieve (14 number)

Motor

• Multimill :It is used for various purposes like granulation, shredding, pulverizing and many more. Its vertically mounted motor model drives the rotor. These are provided with knife blades and scraping blades.

• Sieve Used in Multi mill :- 3/32

Fluidized Bed Dryer

• Multiple zones in the Fluid Bed Dryer allow heating and cooling in the same unit.

• Capacity : 500 litre

• Running Time: - 2 Hrs (Approx)

• UTILITY:drying, heating, cooling, calcining, reacting, dedusting, or agglomerating.

Tablet Compression

• Double Rotary Tablet Compression Machine • Single Rotary Tablet Compression Machine

FETTE 3090• When producing medium to extra large batches, the

3090i double sided rotary press helps you achieve maximum productivity. Fette Compacting offers this unit with Wash-in-Place (WiP) technology as well as WiP and check containment .

Double rotary tablet compression machine

TABLET COATING

• Types of tablet coating :-• Three main types are in use:-

– Film coating– Sugar coating– Press coating

GLATT AUTOCOATER– PAM Glatt GC Smart® high-speed coating machine, one has

to understand the process of coating, and the issues related to it. The most common method used is perforated pan coating

• Glatt has designed and developed parts of the machine after extensive research, creating a machine that addresses both handling and process control issues of other machines, giving the industry a truly ‘Smart’ tool.

General Steps/process of coating machine

TABLET COATING

Parts Of Tablet Coating Machine• Spray Nozzle (Solution+ air)• Air Blower •Solution Dye Container• Pump•Exhaust •Coating Pan

Packaging can be defined as an economical means of providing, presentation, protection, identification/information, containment, convenience and compliance for a product during storage, carriage, display and use until such time as the product is used Primary Pack:- The primary pack consists of those packaging components that form the part of the pack directly containing the product (i.e. bottle, cap, cap liner etc.).

Secondary Pack:- The packaging external to the primary pack, known as the secondary packaging .Its role is to mainly provides the additional physical protection.

Packaging MaterialsPackaging types, styles and systems can be broadly defined by the material of construction,.

Glass,Plastic, Metal, Rubber, etc

In Cipla ltd only plastic packaging is used.•Polyvinyl chloride (PVC)

Tablet Packaging:

INTRODUCTION:

•Nasal spray can come in a variety of forms such as medicated and natural.•They are used as local treatments for conditions such as nasal congestions and allergic rhinitis.•Nasal spray are seen as a more efficient way of transporting drugs with potential use in crossing the CRITICAL EQUIPMENT-The machine with in a system where the Malfunctioning or Failure of equipment will not have direct impact on product quality or where product is in direct contact with machine body parts.

NON-CRITICAL EQUIPMENT-The machine within a system where Malfunctioning or Failure of equipment will not have direct impact on product quality or where product is not in direct contact with machine body parts.

Blood Braine Barrier.

Nasal Spray Preparation

• Blister Packaging for Tablets• 6 to 6.5 lac Tablets are packed in 8 hours.• PVC specifications :-• PVC 250• Width in : 156 mm• Thickness : 0.27 mm• Sealing Temp : 236˚c• Forming Temp : 130˚ c• Thickness of Foil : 0.05 mm

• Strip Packing For Tablets• Tablets are packed in between the two strip of aluminium

foil.• Every day 3 to 3.5 lac tablets are packed.• Temp : 50-56 c• RPM : 36

CONCLUSION

• After, undergoing Industrial Training at Macleod's pharmaceuticals Ltd. I ,came to know about the dedication and hard work that the employees put in production department.

• I had completely understand the difference between the practical and theoretical knowledge.

• I also got good exposure of industrial enviroment.• Finally I want to acknowledge my acedemic guide

and MR. Baldev Thakur as they gave me the opportunity to work there.