“ 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 : 10 th may’08 - 10 th june’08

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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.

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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.

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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

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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,

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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 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

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PRODUCT LIST

PHARMA PRODUCTS

SR.NO.

Name of the Product / Formulation

Composition approved by Drug Control Authorities

Specifications of the Pack

TypePack Size

 NON SCHEDULE PRODUCTS

1 Tab. ALCITAM-800Each film coated tablet contains : Piracetam 800 mg. Tab.

BL 10's

2 Tab. ALERMINEEach uncoated tablet contains : Dexchlorpheniramine Maleate U.S.P. 2 mg Tab.

BL 10's

3 Tab. AM-ATEach uncoated tablet contains : Amlodipine 5 mg + Atenolol 50 mg Tab.

BL 10's

4 Tab. AZOLEEach uncoated chewable tablet contains : Albendazole I.P.400mg. Tab.

BL 1's

5 Susp. AZOLEEach 5ml. Contains : Albendazole I.P. 200mg. Susp.

Glass 10 ml

6 Tab. BALANCEEach uncoated tablet contains : Allylestrenol 5mg.

BL 10's

7 Syrup DEBON

Each 15ml. Contains : Calcium Lactate I.P.450mg.,Calcium Gluconate I.P.450mg., Vitamin D3 I.P.600 I.U., Vitamin B12 I.P.15mcg., L-lysine Monohydrochloride U.S.P. 250mg.Syrup

Pet 200 ml

8 Tab. DEBON Each film coated tablet contains : Calcium Carbonate I.P.1.25gm. + Elemental Calcium 500mg.+Vitamin D3 I.P. 250 I.U. Tab.

BL 10's

9      DIALGIN GELDiclofenac+linseed Oil +Methyl Salicylate + Menthol Gel

Al 30 gm

10 Tab. DIALOZEach Enteric Coated tablet contains : Rebeprazole Sodium 20mg. Tab.

BL 10's

11 Syrup DIGICURE Each 5 ml. Contains : Diastase I.P.(1:1200) 50mg. (Fungal Diastase), Pepsin I.P. (1:3000) 10mg. Digestive Enzyme Syrup

Pet 200 ml

12 Syrup DIGICURE Each 5 ml. Contains : Diastase I.P.(1:1200) 50mg. Pet 100 ml

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(Fungal Diastase), Pepsin I.P. (1:3000) 10mg. Digestive Enzyme Syrup

13 Tab. DICLONEEDEach uncoated tablet contains : Diclofenac Sodium I.P.50mg. + Paracetamol I.P.500mg. Tab.

BL 10's

14 Cap. DILMOX-250Each hard gelatin capsule contains :Amoxycillin 250mg. Cap.

BL 10's

15 Tab. DILMOX-250Each uncoated Dispersible tablet contains : Amoxycillin .250 mg. Dispersible Tab.

BL 10's

16 Cap. DILMOX-500Each hard gelatin capsule contains : Amoxycillin 500 mg. Cap.

BL 10's

17 Cap. DIMRID-20Each hard gelatin capsule contains : Fluoxetine 20mg. Cap.

BL 10's

18 Syrup D-LIZEREach 5ml. Contains : Disodium Hydrogen Citrate B.P.1.53gm. /per 5ml. Alkalizer Syrup

Glass 100 ml

19 Syrup D-LIFEEach 5ml. Contains : D-Fructose U.S.P.3.25 gm. + Choline chloride 312.5 mg. Sorbitol base Syrup

Glass 15 ml

20 Tab. DOXYFRESH

Each enteric coated tablet contains : Doxylamine Succinate U.S.P. 10mg. +Pyridoxine Hydrochloride I.P. Vitamin B6 10mg.(Pyridoxine HCL) Tab.

BL 10's

21Tab. DOXYFRESH - F

Each enteric coated tablet contains : Doxylamine Succinate U.S.P. 10mg. + Pyridoxine Hydrochloride I.P. 10mg. + Folic Acid I.P. 2.5mg. Tab.

BL 10's

22 Syrup D-CYPROEach 5 ml. contains : Cyproheptadine HCL 2mg.Syrup

Glass 200 ml

23 Tab. D-CYPROEach uncoated tablet contains : Cyproheptadine 4 mg. Tab.

  10's

24 Cap. D-CHLOR-250Each hard gelatin capsule contains : Chloramphenicol I.P. 250mg. Cap.

BL 10's

25 Tab. D-KAM 0.25Each uncoated tablet contains : Alprazolam I.P.0.25 mg. Tab.

BL 10's

26 Tab. D-KAM 0.50Each uncoated tablet contains : Alprazolam 0.50 Tab.

BL 10's

27Tab. D-THROCINE 150

Each film coted tablet contains : Roxythromycin B.P.150 mg. Tab.

BL 10's

28Tab. D-THROCINE KID

Each uncoted dispersible tablet contains: Roxythromycin B.P.50 mg Kid Tab.

BL 10's

29 Tab. ENDOSPAZEach film coted tablet contains : Dicyclomine Hydrochloride I.P. 20mg. +Diclofenac Potassium B.P.50 mg. Tab.

BL 10's

30 Tab. ENDOSPAZ-SEach enteric coated tablet contains : Diclofenac Potassium B.P.50mg. + Serratioptetidase 10mg. Tab.

BL 10's

31 Tab. FITCUREEach uncoted tablet contains : Phenobarbiton I.P.50mg. +Phenytoin Sodium I.P.100 mg. Tab.

BL 10's

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32 Tab. FLUZEDEach uncoted tablet contains : Fluconazole 150 mg. Tab.

Al 1's

33 Tab. FOLCIDILEach uncoted tablet contains: Folic Acid I.P.5 mg. Tab.

BL 10's

34 Cap. HEMRAISE

Each Capsule contains : Carbonyl Iron 100mg. Folic Acid I.P.1mg., Vitamine B12 I.P.5mcg., Selenium 65mcg., Vitamine E Acetate I.P. 15mg., Zinc sulphate Monohydrate U.S.P. 43mg. Cap.

BL 10's

35 Syrup HEMRAISE Each 5ml. Contains : Elemental Iron 50mg. Folic Acid 0.5mg.,Cyanocobalamin I.P.6mcg., Elemental Zinc 11mg. Syrup

Glass 150 ml

36 Tab. HEMODILEach film coated Tablet contains : Ethamsylate B.P.250 mg. Tab.

Al 10's

37 Tab. HYGESIC Each uncoated Tablet contains : Diclofenac Sodium I.P. 50mg.+ Paracetamol I.P.325 mg. + Chlorzoxazone U.S.P. 250 mg. Tab.

BL 10's

38 Tab. ISOPRIX-10Each uncoated Tablet contains : Isoxuprine Hydrochloride I.P.10mg. Tab.

BL 10's

39 Tab. ISOPRIX-20Each uncoated Tablet contains : Isoxuprine Hydrochloride I.P.20 mg. Tab.

BL 10's

40 Tab. ISOPRIX-40 SREach uncoated sustained release Tablet contains : Isoxuprine Hydrochloride I.P.40 mg. SR Tab.

BL 10's

41 Tab. LACFREEEach uncoated Tablet contains : Lactic Acid Bacillus 60 mill. spores Tab.

BL 10's

42 Susp. LAXI-DEach 15ml. Contains : Milk of Magnnesia I.P.11.25ml. +Liquid Paraffin I.P. 3.75ml.

Glass 170 ml

43 Tab LEVODIL-250Each film coated Tablet contains : Levofloxacin 250 mg. Tab.

BL 10's

44 Tab LEVODIL-500Each film coated Tablet contains : Levofloxacin 500 mg. Tab.

BL 10's

45 Tab LEVODIL OZEach film coated Tablet contains : Levofloxacin 250 mg.+Ornidazole 500mg. Tab.

BL 10's

46 TAB MACGILEach uncoated tablet contains : Matformin HCL I.P.500mg+Gliclazide B.P. 80mg. Tab.

BL 10's

47Tab. MANAGE PLUS

Each uncoated tablet contains: Lisinopril U.S.P 5mg.+ Amlodipin 5 mg. Tab.

BL 10's

48 Tab. MAXI-D 100Each uncoted dispersible tablet contains: Cefixime U.S.P 100 mg. Tab.

Al 10's

49 Tab. MAXI-D 200Each film coated contains: AnhydrousCefixime 200 mg. Tab.

Al 10's

50 Syrup (Dry) Maxi -DEach 5ml. Contains : Anhydrous Cefixime 50mg. Syrup

Plastic 30ml

51 Tab. MEPZOL PDEach enteric coated tablet contains : Pantoprazole 40mg.+ Domperidone B.P. 10mg. Tab.

Al 10's

52 Tab. MEPZOL-PEach enteric coated tablet contains: Pantoprazole 40 mg. Tab.

Al 10's

53 Cap. MEPZOL-20 Each capsule contains : Omeprazole I.P 20mg. Al 10's

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Cap.

54 Susp. M D ZOLEEach 5 ml contains : Ofloxacin U.S.P. 50mg. + Ornidazole 125mg. Susp.

Glass 30 ml

55 Tab. MINICEach uncoated tablet contains : Phenyl Propolamine Hcl B.P. 25mg.+CPM IP 4mg.Tab

BL 10's

56 Susp. MINICEach 5 ml contains : Paracetamol I.P 125mg.+CPM I.P.2mg. + Phenyl Propalamine Hydrochloride B.P. 12.5mg.

Pet 60ml

57 Tab.MINIDOL-200Each Uncoated tablet contains : Nimesulide B.P. 200 mg. Tab.

BL 10's

58 Tab.MINIDOL-DTEach uncooated dispersible tablet contains : Nimesulide B.P. 100mg. Tab.

BL 10's

59 Tab. MINIDOL-PEach uncoated tablet contains : Nimesulide B.P. 100mg. + Paracetamol I.P.325mg. Tab.

BL 10's

60 Susp. MINIDOL-PEach 5 ml contains : Nimesulide B.P 50mg + Paracetamol I.P. 125 mg

Pet 60 ml

61Tab. MINIDOL-PLUS

Each uncoated tablet contains : Nimesulide B.P. 100mg. + Chlorzoxazone U.S.P 250mg. Tab.

BL 10's

62 Tab. MINIMAX-200Each film coated tablet contains : Ofloxacin U.S.P 200mg. Tab.

BL 10's

63 Tab. MINIMAX-400Each film coated tablet contains : Ofloxacin U.S.P 400mg. Tab.

BL 10's

64 MINIMAX Susp. Each 5 ml contains : Ofloxacin U.S.P. 500mg. Glass 30 ml

65 Tab. MINIMAX-TZEach film coated tablet contains: Ofloxacin U.S.P 200mg.+Tinidazole I.P. 600mg. Tab.

BL 10's

66 Tab. MORZIT-100Each uncoated dispersible tablet contains : Azithromycin base100mg. Tab.

Al 3's

67 Tab. MORZIT-250Each film coated tablet contains : Azithromycin 250 mg. Tab.

BL 6's

68 Tab. MORZIT-500Each film coated tablet contains : Azithromycin 500 mg. Tab.

BL 2's

69 Susp. NILACIDEach 5 ml contains : Dried Aluminium Hydroxide gel I.P.250mg+simethicone I.P 50mg +Magnesium Hydroxide I.P 250mg

Pet 200 ml

70 Tab. NEO-M-TEach uncoated vaginal tablets contains : Neomycin 20mg.+Miconazole I.P 100mg. + Tinidazole I.P. 500mg. Vaginal Tab.

Al 6's

71 Tab. NEOSAL-25Each film coated tablet contains : Trioxasalen U.S.P 25 mg. Tab.

Al 10's

72 Tab. NEOSAL-5Each uncoated tablet contains : Trioxsalen U.S.P 5 mg. Tab.

BL 10's

73 Cap. NEWZOL -30Each capsule contains : Lansoprazole U.S.P 30 mg. Cap.

Al 10's

74 Tab. PAINEXEach uncoated tablet contains : Amoxipine U.S.P 50 mg. Tab.

BL 10's

75 Tab. PARATOP 500Each uncoated tablet contains : Paracetamol 500mg. I.P.Tab.

BL 10's

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76 Tab. PARATOP 650Each uncoated tablet contains : Paracetamol 650 mg. I.P.Tab.

BL 10's

77 Tab. PERISTOPEach uncoated dispersible tablet contains : DomperidoneB.P. 10 mg. Tab.

BL 10's

78 Susp. PERISTOPEach ml. Contains : Domperidone B.P. …1mg. Susp.

Glass 30 ml

79 Tab. PRIDE-10Each uncoated tablet contains : Cisapride B.P.10 mg. Tab.

BL 10's

80 Tab. PRIME 50Each uncoated Dispersible tablet contains : Cefpodoxime 50 mg. Tab.

Al 10's

81 Tab. PRIME 200Each film coated tablet contains : Cefpodoxime Proxetil U.S.P 200 mg. Tab.

Al 10's

82Dry Syrup PRIME 50

Each 5 ml(After recontitution) contains : Cefpodoxime Prixetil U.S.P 50 mg.

Pet 30 ml

83 Tab. PROXY-20 DTEach uncoated dusoersible tablet contains : Piroxicam I.P 20mg.

BL 10's

84 Syrup PARATOPEach 5ml. Contains : Paracetamol I.P. 125mg. Syrup.

Glass 60 ml

85 Tab. REFERTEach uncoated tablet contains : Clomiphene I.P 50 mg. Tab.

BL 5's

86 Tab. RIVOL-200Each uncoated tablet contains : Acyclovir I.P 200 mg. Tab.

BL 10's

87 Tab. RIVOL-800Each uncoated tablet contains : Acyclovir I.P. 800 mg. Tab.

BL 10's

88Tab. SARDINIL-FORTE

Each uncoated tablet contains : Paracetamol I.P 500mg.+CPM 2mg.+ Phenylepherine 5mg.+Caffeine 25mg.Tab.

Pet 10's

89 Syrup SARDINIL-PEach 5ml contains : DMR 10mg.+CPM I.P.2mg.+ PhenylProp B.P.12.5mg. (Cough Syrup)

Pet 60 ml

90 Tab. SPARONE-200Each film coated tablet contains : Sparfloxacin 200mg. Tab.

BL 10's

91Tab. SEPHALIN – 250 DT

Each uncoated Dispersible tablet contains: Cephalexin I.P.250 mg.

BL 10's

92Cap. SEPHALIN -500

Each Hard Gelatin Capsules contains : Cephalexin I.P 500 mg. Cap.

BL 10's

93 Tab. SIMOZINE-DTEach uncoated dispersible tablet contains : Cetrizine B.P. 10 mg. Tab.

BL 10's

94 Tab. TORA - 10Each enteric coated tablet contains : Serratiopeptidase 10mg. Tab.

BL 10's

95 Tab. URAXE-250Each Film coated tablet contains : Cefuroxime Axetil U.S.P.250 mg. Tab.

Al 4's

96TAB URAXE-

500Each Film coated tablet contains : Cefuroxime Axetil U.S.P.500 mg. Tab.

Al 4's

  SCHEDULE PRODUCTS  

1 Tab. BETASONEEach uncoated tablet contains : Betamethasone 0.5mg. Tab.

BL 10's

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2Tab.BETASONE FORTE

Each uncoated tablet contains : Betamethasone 1 mg. Tab.

BL 10's

3 Tab. CIPRODIL-250Each film coated tablet contains : Ciprofloxacin 250 mg. Tab.

BL 10's

4 Tab. CIPRODIL-500Each film coated tablet contains : Ciprofloxacin 500 mg. Tab.

BL 10's

5 Tab. CIPRODIL-TZEach film coated tablet contains : Ciprofloxacin base 500mg. +Tinidazole I.P. 600mg. Tab.

BL 10's

6 Tab. CYNORYL-250Each uncoated tablet contains : Erythromycin base.250 mg. Tab.

BL 10's

7 Tab. FUNGONIL-FEach uncoated tablet contains : Griseofulvin I.P. 250 mg. Tab.

BL 10's

8 Tab. NILACID-20Each uncoated tablet contains : Famotidine U.S.P 20mg. Tab.

BL 10's

9 Tab. NILACID-40Each film coated tablet contains : Famotidine U.S.P 40 mg. Tab.

BL 10's

 

TRAINING SCHEDULE

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PARENTRALS

Products Under manufacturing:

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

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INJECTABLE PRODUCTS

 

SR.NO.

NAME OF PRODUCTS AND COMPOSITION

PACKING

1DICEF Injection 1 gm.

VialCeftriaxone

2DICEF Injection 250 mg.

VialCeftriaxone

3ACIDRIM O Injection

2 mlOndansetron HCL U.S.P.

4ACIDRIM O Injection

4 mlOndansetron HCL U.S.P.

5DICLONEED Injection

6 mlDiclofenac Sodium I.P.

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.

8-STOCK FILLING AND SEALING

6-STOCK WASHING SEALING STERILIZATION FILLING AND

VIAL FILLING AND SEALING

D.H.S. TROLLY

FILTRATIONTANK

PROCESS RAW MATERIAL

DECARTING

LEAK TESTING AND AUTOCLAVE WASHING

CONTAINER

.

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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 placeAfter 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.

LIQUID ORALS

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: 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 hopperFrom 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:-

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 unit3) Filling Tank with 8 syringes ( 35 litres)4) Block filling and sealing machine5) Filled Bottle Inspection Unit for visual inspection6) Labeling and Packing

RAW MATERIAL& PACKING MATERIAL STORAGE

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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 receivedGRN(Goods Receipt Note) is prepared.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 BoothHere sampling of material takes place under RLAF (Reverse Laminar Air Flow) in presence of QC Chemist—after this RM is labeled SAMPLEDRM is stored in Under Test Area awaiting QC Release demarcated by yellow stringOn Approval from QC- RM is stored under Approved AreaIf Rejected By QC- RM is stored under Rejected AreaFor 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 orals2)Dispensing-II-for Parenterals

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

RLAF is switched 10 mins prior to dispensing

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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 :

(b) The Packing Material Store works in a similar manner as the RM1) 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 MaterialEg:- Cartons, tape roll, boxes, bubbling bag, thermool balls, interlocker, literature.Labels are stored under lock and key

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QUALITY CONTROL

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

1) Karl Fischer Titrator-for determining moisture content in material2) Chemiline Photo fluorometer 3) Tablet dissolution tester- for determining the dissolution time of tablet4) Disintegration Tester ED-ZAL 5) Refractometer6) Polarimeter – for determining the optical rotation7) UV-1601 UV Visible Spectrophotometer8) Friabilator USP- for determining surface hardness of tablets9) Bulk Density Apparatus10) Melting and Boiling Point Apparatus11) Ubique- Bursting Strength Apparatus12) pH meter and Conductivity meter13)Brookfield Viscometer14)Autoclave and Hot Air Ovens 15)Titration Equipments

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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

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. FriabilityIV. HardnessV. Disintegration timeVI. Coating

VII. Leak TestingVIII. 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.

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

a. Glass particlesb. Fibre particlesc. Black particlesd. Volumee. Shape and size of ampoulef. Presence of any sharp edgesg. 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

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TABLET & CAPSULE

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

a. Dispensing and Sieving of ingredientsb. Blendingc. Granulation and Millingd. Dryinge. Compressionf. Film Coatingg. Packaging

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.

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22

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).

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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.

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