“ We say everything in black and white to make your life colorful ”

1) Padriya Ronak R.
Parul Institute Of Pharmacy,
Gujarat University.

Report of the ONE MONTH training : 10th may’08 - 10th june’08

1
 CERTIFICATE
This is to certify that this is the original report as per the industrial training undergone by
us for partial fulfillment of B.Pharm as per Gujarat University, Ahmedabad, in The Dial
Pharmaceuticals Pvt Ltd. from 10/05/2008 to 10/06/2008. We also certify that this is
an authentic report submitted by us and not duplicated or copied from any source
already available.

Dr. Rajesh K.S.

Principle,
Parul Institute of Pharmacy.

2
 Acknowledgement

• We are grateful to our principal sir, Dr. Rajesh K.S. and Mrs. Anveshna Bhatt for
organizing this industrial training for us.

• We are also very much thankful to,

.Mr. SANJAY SHETH, the Chairman & Managing Director of
The Dial Pharmaceuticals Ltd.

• They all took out time from their busy schedule to enlighten us on some very
interesting aspects of industry.
• The experience has been highly knowledgeable and helped us in understanding
pharmacy from a different perspective. It has definitely enlightened us and shown
us a part that we were unaware of.

3
 INDEX

1. Introduction & layout of Dial Pharmaceuticals 4

2. Products List 6
3. Training schedule 12
4. Brief report on the nature of training under gone department wise 13
5. General scheme for receipt and testing of Raw material 16
6. Flow chart for the processing of Tablets/capsules 22
7. Summary 23
8. Conclusion 24

4
 INTRODUCTION

DIAL PHARMACEUTICALS PVT. LTD.

COMMITTED TO CARE MENTAL ILLNESS AND HUMAN HEALTH CARE

DIAL is rendering services to the people of our Country with adequate supply in
large quantities of it’s products at economical rates. The main Specialties of DIAL are
Pharma Products (Tablets, Capsules & Injectables) complete COSMETICS Range of
Products, Ayurvedic/Herbal Products and also manufacture wide range of Antibiotics,
Enzymes, Vitamin & Tonics. The Company believes in developing and using innovative,
environment friendly , cost effective and safe technology and have the tradition to
provide services to ailing humanity.

DIAL has the motto of providing HEALTH FOR ALL. The Company was
established in 1985 and has come a long way to build a strong and quality products to
earn a goodwill and excellent reputation in the Country. Today, DIAL has reached new
heights of growth in the field under the able leadership and motivating force for
Group - Mr. SANJAY SHETH, the Chairman & Managing Director.

DIAL being WHO-GMP Certificate Holder, adhere to the meticulous and rigorous
quality control at all production levels, which ensures reliability, quality and
performance of highest degree in accordance with the WHO-GMP Standard. DIAL has
engraved it’s name in ORG List and out of 25,000 Pharmaceutical Companies, it’s
name has been published within top ranked 250 Pharmaceutical Manufacturers in
India. The Factory equipped with most ultra modern Machineries and the Plant is
endowed with Sophisticated instruments including HPCL, Spectrophotometer Meter
etc and well equipped microbiological testing section.

DIAL also has a Formulation development department to develop New

Formulations. DIAL also introduced Injectable range consisting of Antibiotics &
Psychotropics which have a huge market potential. DIAL products enjoy a tremendous
market acceptance, goodwill and popularity. The Product Manual, Literature and
Glossary enhance the image of DIAL maxim.

The Quality Assurance Department is headed by a Team of Technocrats and

skilled staff to ensure TOTAL QUALITY MANAGEMENT (TQM) is implemented in the
Factory to ensure Quality of our products. The leading products of DIAL are
Psychotropic range of products and Ayurvedic Herbal products. Our aim is to reach on
TOP in the shortest possible time by keeping pace with the latest developments in the
World of Drugs. Our impressive list of clients includes leading Distributors, Doctors,
Government Organizations, Hospitals, Nursing Homes, who are repeatedly patronizing
DIAL Specialties. Some of the well known includes Railways, Defense, Electricity
Boards, P & T and so on. - 2 - It has been the tradition for us to keep in touch with the
latest techniques of Sales Promotion. DIAL always try to render valuable assistance to
all Distributors and Customers promptly so that they can avail “FASTER AFTER SALES
SERVICES” from the Company and for this very purpose, DIAL has set up a Marketing
& Export Division at it’s Corporate Office and Marketing operations are divided into

5
four Zones- North, East, West and South, led by various Managers and Executives
assisted by team of dedicated Field Forces. The Company has an ambitious plan to
export it’s specialties ABROAD for which the Company is now developing full fledged
Export Division led by qualified and experienced Export Expertise. The Department is
mainly engaged in the development of New Products with economical rates to cater to
the needs of market requirements and also to care Mental illness and human health
care.

Products of all age groups and class of people to help them to improve the life

Antibiotics & Antibacterials

T.B. Regiments

Analgesics & Antipyretics

Vitamins & Tonics

Antimalarials

PRODUCT LIST

6
PHARMA PRODUCTS

Specifications
Name of the
SR. Composition approved by Drug Control of the Pack
Product /
NO. Authorities Pack
Formulation Type
Size
NON SCHEDULE
PRODUCTS
Each film coated tablet contains : Piracetam 800
1 Tab. ALCITAM-800 BL 10's
mg. Tab.
Each uncoated tablet contains :
2 Tab. ALERMINE BL 10's
Dexchlorpheniramine Maleate U.S.P. 2 mg Tab.
Each uncoated tablet contains : Amlodipine 5 mg
3 Tab. AM-AT BL 10's
+ Atenolol 50 mg Tab.
Each uncoated chewable tablet contains :
4 Tab. AZOLE BL 1's
Albendazole I.P.400mg. Tab.
Each 5ml. Contains : Albendazole I.P. 200mg.
5 Susp. AZOLE Glass 10 ml
Susp.
6 Tab. BALANCE Each uncoated tablet contains : Allylestrenol 5mg. BL 10's
Each 15ml. Contains : Calcium Lactate
I.P.450mg.,Calcium Gluconate I.P.450mg.,
7 Syrup DEBON Pet 200 ml
Vitamin D3 I.P.600 I.U., Vitamin B12 I.P.15mcg.,
L-lysine Monohydrochloride U.S.P. 250mg.Syrup
8 Tab. DEBON Each film coated tablet contains : Calcium BL 10's
Carbonate I.P.1.25gm. + Elemental Calcium
500mg.+Vitamin D3 I.P. 250 I.U. Tab.
Diclofenac+linseed Oil +Methyl Salicylate +
9 DIALGIN GEL Al 30 gm
Menthol Gel
Each Enteric Coated tablet contains : Rebeprazole
10 Tab. DIALOZ BL 10's
Sodium 20mg. Tab.
11 Syrup DIGICURE Each 5 ml. Contains : Diastase I.P.(1:1200) 50mg. Pet 200 ml
(Fungal Diastase), Pepsin I.P. (1:3000) 10mg.
Digestive Enzyme Syrup
12 Syrup DIGICURE Each 5 ml. Contains : Diastase I.P.(1:1200) 50mg. Pet 100 ml
(Fungal Diastase), Pepsin I.P. (1:3000) 10mg.
Digestive Enzyme Syrup
Each uncoated tablet contains : Diclofenac
13 Tab. DICLONEED BL 10's
Sodium I.P.50mg. + Paracetamol I.P.500mg. Tab.
Each hard gelatin capsule contains :Amoxycillin
14 Cap. DILMOX-250 BL 10's
250mg. Cap.
Each uncoated Dispersible tablet contains :
15 Tab. DILMOX-250 BL 10's
Amoxycillin .250 mg. Dispersible Tab.

7
 Each hard gelatin capsule contains : Amoxycillin
16 Cap. DILMOX-500 BL 10's
500 mg. Cap.
Each hard gelatin capsule contains : Fluoxetine
17 Cap. DIMRID-20 BL 10's
20mg. Cap.
Each 5ml. Contains : Disodium Hydrogen Citrate
18 Syrup D-LIZER Glass 100 ml
B.P.1.53gm. /per 5ml. Alkalizer Syrup
Each 5ml. Contains : D-Fructose U.S.P.3.25 gm.
19 Syrup D-LIFE Glass 15 ml
+ Choline chloride 312.5 mg. Sorbitol base Syrup
Each enteric coated tablet contains : Doxylamine
Succinate U.S.P. 10mg. +Pyridoxine
20 Tab. DOXYFRESH BL 10's
Hydrochloride I.P. Vitamin B6 10mg.(Pyridoxine
HCL) Tab.
Each enteric coated tablet contains : Doxylamine
Tab. DOXYFRESH - Succinate U.S.P. 10mg. + Pyridoxine
21 BL 10's
F Hydrochloride I.P. 10mg. + Folic Acid I.P. 2.5mg.
Tab.
Each 5 ml. contains : Cyproheptadine HCL
22 Syrup D-CYPRO Glass 200 ml
2mg.Syrup
Each uncoated tablet contains : Cyproheptadine 4
23 Tab. D-CYPRO 10's
mg. Tab.
Each hard gelatin capsule contains :
24 Cap. D-CHLOR-250 BL 10's
Chloramphenicol I.P. 250mg. Cap.
Each uncoated tablet contains : Alprazolam
25 Tab. D-KAM 0.25 BL 10's
I.P.0.25 mg. Tab.
Each uncoated tablet contains : Alprazolam 0.50
26 Tab. D-KAM 0.50 BL 10's
Tab.
Tab. D-THROCINE Each film coted tablet contains : Roxythromycin
27 BL 10's
150 B.P.150 mg. Tab.
Tab. D-THROCINE Each uncoted dispersible tablet contains:
28 BL 10's
KID Roxythromycin B.P.50 mg Kid Tab.
Each film coted tablet contains : Dicyclomine
29 Tab. ENDOSPAZ Hydrochloride I.P. 20mg. +Diclofenac Potassium BL 10's
B.P.50 mg. Tab.
Each enteric coated tablet contains : Diclofenac
30 Tab. ENDOSPAZ-S Potassium B.P.50mg. + Serratioptetidase 10mg. BL 10's
Tab.
Each uncoted tablet contains : Phenobarbiton
31 Tab. FITCURE BL 10's
I.P.50mg. +Phenytoin Sodium I.P.100 mg. Tab.
Each uncoted tablet contains : Fluconazole 150
32 Tab. FLUZED Al 1's
mg. Tab.
Each uncoted tablet contains: Folic Acid I.P.5
33 Tab. FOLCIDIL BL 10's
mg. Tab.
Each Capsule contains : Carbonyl Iron 100mg.
Folic Acid I.P.1mg., Vitamine B12 I.P.5mcg.,
34 Cap. HEMRAISE BL 10's
Selenium 65mcg., Vitamine E Acetate I.P. 15mg.,
Zinc sulphate Monohydrate U.S.P. 43mg. Cap.

8
 Each 5ml. Contains : Elemental Iron 50mg. Folic
35 Syrup HEMRAISE Acid 0.5mg.,Cyanocobalamin I.P.6mcg., Glass 150 ml
Elemental Zinc 11mg. Syrup
Each film coated Tablet contains : Ethamsylate
36 Tab. HEMODIL Al 10's
B.P.250 mg. Tab.
Each uncoated Tablet contains : Diclofenac
37 Tab. HYGESIC Sodium I.P. 50mg.+ Paracetamol I.P.325 mg. + BL 10's
Chlorzoxazone U.S.P. 250 mg. Tab.
Each uncoated Tablet contains : Isoxuprine
38 Tab. ISOPRIX-10 BL 10's
Hydrochloride I.P.10mg. Tab.
Each uncoated Tablet contains : Isoxuprine
39 Tab. ISOPRIX-20 BL 10's
Hydrochloride I.P.20 mg. Tab.
Each uncoated sustained release Tablet contains :
40 Tab. ISOPRIX-40 SR BL 10's
Isoxuprine Hydrochloride I.P.40 mg. SR Tab.
Each uncoated Tablet contains : Lactic Acid
41 Tab. LACFREE BL 10's
Bacillus 60 mill. spores Tab.
Each 15ml. Contains : Milk of Magnnesia
42 Susp. LAXI-D Glass 170 ml
I.P.11.25ml. +Liquid Paraffin I.P. 3.75ml.
Each film coated Tablet contains : Levofloxacin
43 Tab LEVODIL-250 BL 10's
250 mg. Tab.
Each film coated Tablet contains : Levofloxacin
44 Tab LEVODIL-500 BL 10's
500 mg. Tab.
Each film coated Tablet contains : Levofloxacin
45 Tab LEVODIL OZ BL 10's
250 mg.+Ornidazole 500mg. Tab.
Each uncoated tablet contains : Matformin HCL
46 TAB MACGIL BL 10's
I.P.500mg+Gliclazide B.P. 80mg. Tab.
Tab. MANAGE Each uncoated tablet contains: Lisinopril U.S.P
47 BL 10's
PLUS 5mg.+ Amlodipin 5 mg. Tab.
Each uncoted dispersible tablet contains:
48 Tab. MAXI-D 100 Al 10's
Cefixime U.S.P 100 mg. Tab.
Each film coated contains: AnhydrousCefixime
49 Tab. MAXI-D 200 Al 10's
200 mg. Tab.
Each 5ml. Contains : Anhydrous Cefixime 50mg.
50 Syrup (Dry) Maxi -D Plastic 30ml
Syrup
Each enteric coated tablet contains : Pantoprazole
51 Tab. MEPZOL PD Al 10's
40mg.+ Domperidone B.P. 10mg. Tab.
Each enteric coated tablet contains: Pantoprazole
52 Tab. MEPZOL-P Al 10's
40 mg. Tab.
Each capsule contains : Omeprazole I.P 20mg.
53 Cap. MEPZOL-20 Al 10's
Cap.
Each 5 ml contains : Ofloxacin U.S.P. 50mg. +
54 Susp. M D ZOLE Glass 30 ml
Ornidazole 125mg. Susp.
Each uncoated tablet contains : Phenyl
55 Tab. MINIC BL 10's
Propolamine Hcl B.P. 25mg.+CPM IP 4mg.Tab
Each 5 ml contains : Paracetamol I.P
56 Susp. MINIC 125mg.+CPM I.P.2mg. + Phenyl Propalamine Pet 60ml
Hydrochloride B.P. 12.5mg.

9
 Each Uncoated tablet contains : Nimesulide B.P.
57 Tab.MINIDOL-200 BL 10's
200 mg. Tab.
Each uncooated dispersible tablet contains :
58 Tab.MINIDOL-DT BL 10's
Nimesulide B.P. 100mg. Tab.
Each uncoated tablet contains : Nimesulide B.P.
59 Tab. MINIDOL-P BL 10's
100mg. + Paracetamol I.P.325mg. Tab.
Each 5 ml contains : Nimesulide B.P 50mg +
60 Susp. MINIDOL-P Pet 60 ml
Paracetamol I.P. 125 mg
Tab. MINIDOL- Each uncoated tablet contains : Nimesulide B.P.
61 BL 10's
PLUS 100mg. + Chlorzoxazone U.S.P 250mg. Tab.
Each film coated tablet contains : Ofloxacin
62 Tab. MINIMAX-200 BL 10's
U.S.P 200mg. Tab.
Each film coated tablet contains : Ofloxacin U.S.P
63 Tab. MINIMAX-400 BL 10's
400mg. Tab.
64 MINIMAX Susp. Each 5 ml contains : Ofloxacin U.S.P. 500mg. Glass 30 ml
Each film coated tablet contains: Ofloxacin U.S.P
65 Tab. MINIMAX-TZ BL 10's
200mg.+Tinidazole I.P. 600mg. Tab.
Each uncoated dispersible tablet contains :
66 Tab. MORZIT-100 Al 3's
Azithromycin base100mg. Tab.
Each film coated tablet contains : Azithromycin
67 Tab. MORZIT-250 BL 6's
250 mg. Tab.
Each film coated tablet contains : Azithromycin
68 Tab. MORZIT-500 BL 2's
500 mg. Tab.
Each 5 ml contains : Dried Aluminium
69 Susp. NILACID Hydroxide gel I.P.250mg+simethicone I.P 50mg Pet 200 ml
+Magnesium Hydroxide I.P 250mg
Each uncoated vaginal tablets contains :
70 Tab. NEO-M-T Neomycin 20mg.+Miconazole I.P 100mg. + Al 6's
Tinidazole I.P. 500mg. Vaginal Tab.
Each film coated tablet contains : Trioxasalen
71 Tab. NEOSAL-25 Al 10's
U.S.P 25 mg. Tab.
Each uncoated tablet contains : Trioxsalen U.S.P
72 Tab. NEOSAL-5 BL 10's
5 mg. Tab.
Each capsule contains : Lansoprazole U.S.P 30
73 Cap. NEWZOL -30 Al 10's
mg. Cap.
Each uncoated tablet contains : Amoxipine U.S.P
74 Tab. PAINEX BL 10's
50 mg. Tab.
Each uncoated tablet contains : Paracetamol
75 Tab. PARATOP 500 BL 10's
500mg. I.P.Tab.
Each uncoated tablet contains : Paracetamol 650
76 Tab. PARATOP 650 BL 10's
mg. I.P.Tab.
Each uncoated dispersible tablet contains :
77 Tab. PERISTOP BL 10's
DomperidoneB.P. 10 mg. Tab.
Each ml. Contains : Domperidone B.P. …1mg.
78 Susp. PERISTOP Glass 30 ml
Susp.
Each uncoated tablet contains : Cisapride B.P.10
79 Tab. PRIDE-10 BL 10's
mg. Tab.

10
 Each uncoated Dispersible tablet contains :
80 Tab. PRIME 50 Al 10's
Cefpodoxime 50 mg. Tab.
Each film coated tablet contains : Cefpodoxime
81 Tab. PRIME 200 Al 10's
Proxetil U.S.P 200 mg. Tab.
Dry Syrup PRIME Each 5 ml(After recontitution) contains :
82 Pet 30 ml
50 Cefpodoxime Prixetil U.S.P 50 mg.
Each uncoated dusoersible tablet contains :
83 Tab. PROXY-20 DT BL 10's
Piroxicam I.P 20mg.
Each 5ml. Contains : Paracetamol I.P. 125mg.
84 Syrup PARATOP Glass 60 ml
Syrup.
Each uncoated tablet contains : Clomiphene I.P
85 Tab. REFERT BL 5's
50 mg. Tab.
Each uncoated tablet contains : Acyclovir I.P 200
86 Tab. RIVOL-200 BL 10's
mg. Tab.
Each uncoated tablet contains : Acyclovir I.P. 800
87 Tab. RIVOL-800 BL 10's
mg. Tab.
Each uncoated tablet contains : Paracetamol I.P
Tab. SARDINIL-
88 500mg.+CPM 2mg.+ Phenylepherine Pet 10's
FORTE
5mg.+Caffeine 25mg.Tab.
Each 5ml contains : DMR 10mg.+CPM
89 Syrup SARDINIL-P Pet 60 ml
I.P.2mg.+ PhenylProp B.P.12.5mg. (Cough Syrup)
Each film coated tablet contains : Sparfloxacin
90 Tab. SPARONE-200 BL 10's
200mg. Tab.
Tab. SEPHALIN – Each uncoated Dispersible tablet contains:
91 BL 10's
250 DT Cephalexin I.P.250 mg.
Cap. SEPHALIN Each Hard Gelatin Capsules contains :
92 BL 10's
-500 Cephalexin I.P 500 mg. Cap.
Each uncoated dispersible tablet contains :
93 Tab. SIMOZINE-DT BL 10's
Cetrizine B.P. 10 mg. Tab.
Each enteric coated tablet contains :
94 Tab. TORA - 10 BL 10's
Serratiopeptidase 10mg. Tab.
Each Film coated tablet contains : Cefuroxime
95 Tab. URAXE-250 Al 4's
Axetil U.S.P.250 mg. Tab.
TAB URAXE- Each Film coated tablet contains : Cefuroxime
96 Al 4's
500 Axetil U.S.P.500 mg. Tab.
SCHEDULE PRODUCTS
Each uncoated tablet contains : Betamethasone
1 Tab. BETASONE BL 10's
0.5mg. Tab.
Tab.BETASONE Each uncoated tablet contains : Betamethasone 1
2 BL 10's
FORTE mg. Tab.
Each film coated tablet contains : Ciprofloxacin
3 Tab. CIPRODIL-250 BL 10's
250 mg. Tab.
Each film coated tablet contains : Ciprofloxacin
4 Tab. CIPRODIL-500 BL 10's
500 mg. Tab.
Each film coated tablet contains : Ciprofloxacin
5 Tab. CIPRODIL-TZ BL 10's
base 500mg. +Tinidazole I.P. 600mg. Tab.

11
 Each uncoated tablet contains : Erythromycin BL 10's
6 Tab. CYNORYL-250
base.250 mg. Tab.
Each uncoated tablet contains : Griseofulvin I.P.
7 Tab. FUNGONIL-F BL 10's
250 mg. Tab.
Each uncoated tablet contains : Famotidine U.S.P
8 Tab. NILACID-20 BL 10's
20mg. Tab.
Each film coated tablet contains : Famotidine
9 Tab. NILACID-40 BL 10's
U.S.P 40 mg. Tab.

TRAINING SCHEDULE

DATE DEPARTMENT

10-5-08 to 14-5-08 Parentrals

15-5-08 to 17-5-08 RM/PM/FPS

18-5-08 to 20-5-08 Liquid Orals

21-5-08 to 23-5-08 Quality Control

25-5-08 to10-6-008 Tablet and capsules

10-6-08 Report Submission

13-6-08 Certification

12
 PARENTRALS
Products Under manufacturing:

INJECTABLE PRODUCTS

SR. NAME OF PRODUCTS AND

PACKING
NO. COMPOSITION

DICEF Injection 1 gm.

1
Ceftriaxone Vial
DICEF Injection 250 mg.
2
Ceftriaxone Vial
ACIDRIM O Injection
3 2 ml
Ondansetron HCL U.S.P.

13
 ACIDRIM O Injection
4 4 ml
Ondansetron HCL U.S.P.
DICLONEED Injection
5 6 ml
Diclofenac Sodium I.P.

. 6-STOCK VIAL FILLING

WASHING SEALING AND SEALING
STERILIZATION FILLING AND

D.H.S. 8-STOCK
FILLING
TROLLY
AND
SEALING

LEAK TANK FILTRATION

TESTING
AND
AUTOCLAVE PROCESS RAW
WASHING MATERIAL
CONTAINER DECARTING

The most imprtant feature in this unit is sterility. Care is taken that each and every step
involved in the manufacturer of injectables should be free of contamination i.e
sterilization is carried out first.

Injectables prepared are Baralgin 5 ml Injection; Novalgin 2ml injection; Deriphyllin 2ml
injection

To enter into the parenteral area one has to first change clothes…there is a separate
uniform for it. One also has to disinfect him or herself with disinfectants such as dettol

First of all decartoning of ampoules takes place

After this ampoule washing takes place- 4 washings first with Air, DM water, WFI and
then Air.

Apart from these processes sterilization of filtration tank (200 litres) by autoclave is also
done. Nitrogen flushing of ampoules is also done.
Then ampoule filling and sealing is done and then it goes for visual inspection and
finally labeling and packing.

14
 LIQUID ORALS
:

Suspending agent used : Acasia

Here liquid dosage forms such as suspensions and syrups are prepared.
There are 2 units in this manufacturing area. In the first area syrup is prepared
without active material. The ingredients such as sugar, water ,preservatives are mixed
to prepare a syrup in a Bulk manufacturing Tank ( 2000 litres)

From the Manufacturing Tank the preparation goes for Milling (Colloid Mill).
From this it goes to the Hopper, at the same time other ingredients such as liquid
glucose and fructose and a gum previously soaked in water and stored in a holding tank
in case of suspension are added directly into the hopper
From the hopper it goes to the manufacturing unit where active material along with
flavoring and coloring agents are added and mixed thoroughly

The second Unit consists of following through which liquid preparation takes place:-

15
 1) Mini tunnel empty bottle washing machine – Here washing of empty bottles with
DM water takes place :- 4 sprays inside and 2 sprays outside
2) Then there is an Empty Bottle Inspection unit
3) Filling Tank with 8 syringes ( 35 litres)
4) Block filling and sealing machine
5) Filled Bottle Inspection Unit for visual inspection
6) Labeling and Packing

RAW MATERIAL& PACKING MATERIAL STORAGE

1) RM :- Raw Material Store

PM :- Packing Material Store

a) RAW MATERIAL STORAGE :

There are various zones through which the raw material passes before it goes for
dosage form preparation. The various zones in the RMS are:-

a) Receipt Zone(Receiving Bay)

This is the first zone through which the raw material is received
GRN(Goods Receipt Note) is prepared.

16
Labelling (Name of RM, Date of Receipt, Quantity received , Batch No., Manufacturer’s
Name, Mfg. Date, Expiry Date etc) of RM is checked, RM is also checked for any
damages

b) Sampling Booth
Here sampling of material takes place under RLAF (Reverse Laminar Air Flow) in
presence of QC Chemist—after this RM is labeled SAMPLED
RM is stored in Under Test Area awaiting QC Release demarcated by yellow string
On Approval from QC- RM is stored under Approved Area
If Rejected By QC- RM is stored under Rejected Area
For storing bulk liquids there is a separate store, for flavoring agents, preservatives
there is an A.C Store

c) Dispensing Area

Two dispensing zones for RM

1) Dispensing-I
-for RM of Tablets, Capsules, Liquid orals
2)Dispensing-II
-for Parenterals

Dispensing takes place after verification of Material Requisition order (MRO) given by
the production department with batch no., batch size
Material issued on FIFO basis
For dispensing of RM the dispensing person should wear proper uniform, gloves, nose
mask and proper footwear

RLAF is switched 10 mins prior to dispensing

RLAF has 3 filters –HEPA (limit 7-15 mm) , Intermediate Filter (limit 4-6 mm) and
Negative pressure (1-4 mm)
RLAF takes place in presence of QA chemist

Each zone in the stories daily checked for maintenance of proper temperature (8-25 oC)
humidity(NMT 65 %) and pressure. The stores are cleaned periodically

The S.O.P also mentions about-

• Retesting of raw material

• Handling & Disposal of rejected material
• Inventory checking
• Scrap Disposal
• Maintenance of RLAF. Balances, Cleaning Of AHU, disinfection of various areas

b) PACKING MATERIAL STORAGE :

17
 (b) The Packing Material Store works in a similar manner as the RM
1) The materials stored in this store include:-

1) Primary Material (direct contact with the drug)

Eg:- PVC foils, Aluminium foils, Ampoules, Vials,Bottles

2) Secondary Material
Eg:- Cartons, tape roll, boxes, bubbling bag, thermool balls, interlocker, literature.
Labels are stored under lock and key

QUALITY CONTROL

The various instruments used for quality control of a pharmaceutical are:

1) Karl Fischer Titrator-for determining moisture content in material

2) Chemiline Photo fluorometer
3) Tablet dissolution tester- for determining the dissolution time of tablet
4) Disintegration Tester ED-ZAL
5) Refractometer
6) Polarimeter – for determining the optical rotation
7) UV-1601 UV Visible Spectrophotometer
8) Friabilator USP- for determining surface hardness of tablets
9) Bulk Density Apparatus
10) Melting and Boiling Point Apparatus

18
 11) Ubique- Bursting Strength Apparatus
12) pH meter and Conductivity meter
13)Brookfield Viscometer
14)Autoclave and Hot Air Ovens
15)Titration Equipments

QUALITY ASSURANCE

This department is involved in human resource matters as well as the

programming and management of quality assurance operations in design, developing,
manufacturing and packaging of pharmaceutical products .It ensures customer
satisfaction.

The works carried out are-

1) BMR( Batch Manufacturing Record)

This is the document which consists details of each and every step right from dispensing of raw

material upto its labeling and packing. The details of each and every step is filled by

theconcerned departments and it is the responsibility of the QA chemist to check and verify

19
whether the various parameters of product manufacturing mentioned in the BMR are fulfilled or

not during its manufacturing at regular intervals of time.

2) Product manufacturing

The various parameter mentioned in the BMR are regularly checked by the QA chemist.
For Eg:
In case of tablets- parameters checked are –

I. Humidity and Temperature of various units

II. Weight variation of tablets
III. Friability
IV. Hardness
V. Disintegration time
VI. Coating
VII. Leak Testing
VIII. Labels and packing- the label should have the correct Batch Number,
Manufacturing Date, Expiry Date, Price.
a) There should not be any overprinting on the label.
b) The name of the Drug and its details should be clearly visible.
c) There should not be any empty space in the strip nor any greasing in
the strip.
d) The boxes consisting of cartons of tablets should have proper weight
and packing.

In case of ampoules Visual Inspection is the most important step. The parameters
checked in this process are:-

a. Glass particles
b. Fibre particles
c. Black particles
d. Volume
e. Shape and size of ampoule
f. Presence of any sharp edges
g. Cross labeling should not be there

In case of any of above defects in ampoulesor tablets it is rejected and is recorded and
the corrective measures are taken.If the defects found are large in number then the
whole batch is given for rechecking by the QA chemist

After the verification of all the parameters if appropriate the batch is approved by the QA
department and then it goes for sale. At the same time a control of the batch is also kept
by the QA department for future reference

20
 TABLET & CAPSULE

TABLET :
The main steps involved in formulation of a tablet are:

a. Dispensing and Sieving of ingredients

b. Blending
c. Granulation and Milling
d. Drying
e. Compression
f. Film Coating
g. Packaging

21
CAPSULE :

The steps involved in capsule manufacturing are similar to tablets. First of all
dispensing and sieving of the raw materials takes place followed by mixing. Empty hard
gelatin capsule shells of size 0 are taken.

Then the mixed powder is put in an hopper attached in the capsule filling and locking
automatic machine AF 40T.

The machine also has a vaccum system (deduster) to remove the dust of powder that
spills on the machine.It also has sensors to separate empty capsule shell from the filled
ones and brushes to clean capsule that are often covered with powder.

While this process is on the necessary parameters of the capsule are checked like the
weight, locking strength etc.

Finally it goes for packing and labelling.

22
23
 Summary

We would like to lay that the industry was truly based on hard-work and
perfection. From our perspective and from what we saw, the industry made a genuine
effort to bring out a good quality of products.
Being a small scale industry it has managed to survived through the high
competition.The instruments used and certain processes were up dated and more of
automated, it could make as much as products of its own and also serve to loan
licensees(or third party contract).

24
 Conclusion

After completing our training at DIAL PHARMACEUTICALS PRIVATE LIMITED.

, we will have to revise our thoughts about the pharmacy. Running a Pharmaceutical
Industry is not only about manufacturing drugs but it also requires technical knowledge,
management & marketing abilities and foresight.
This training proved to be very beneficial for us and it will help us in the better
understanding of our final year subjects.
Lastly, this one month training has proved to be a booster for making a good
Pharmacist from us in the future.

25