DCI Pharmaceuticals Pvt. Ltd.
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INTRODUCTION

DCI Pharmaceuticals Pvt. Ltd. is engaged in manufacture of small volume liquid Injectables (viz. ampoules and vials), Ophthalmic & Otic Products, for the past 34 years. The manufacturing site is located at Vidyanagar, on the outskirts of Margao city in the state of Goa-India.

DCI Pharmaceutical Pvt. Ltd. site has been accredited by WHO awarded Good Manufacturing Practice (GMP) Certification
Plot Area: 3000 sq. m. (60 x 50 m)

M/s DCI Pharmaceuticals Pvt. Ltd. has a state of art pharmaceutical formulation facility located at Vidhyanagar, Margao – Goa India 403 601

DCI Pharmaceuticals Pvt. Ltd. is an existing Pharmaceutical Company engaged in manufacture of small volume liquid Injectables (viz. ampoules and vials), Ophthalmic & Otic Products, for the past 36 years.

The manufacturing site is located at Vidyanagar, on the outskirts of Margao city in clean surroundings. There is not a single industry polluting around the site.

  • Plot Area: 3000 sq. m. (60 x 50 m)

Pharmaceutical manufacturing activities as licensed by the National Authority.

The Company possesses Drug Manufacturing License from Food and Drugs Administration, Goa, as under:

  • License No. 17 dated 20.04.77 – for Drugs coming under Schedule C and C1
  • The following formulations are manufactured at the site:
  • Small Volume liquid Injectables in ampoules and vials
  • Ophthalmic & Otic products

All the above products are manufactured on campaign basis as far as possible. No other activities apart from those mentioned above are carried out on the site.

Our Vision

“To Build A Globally Oriented, Professionally Managed, Socially Aware and Environmentally Conscious Organization, Committed To Provide The Best In Quality Healthcare”

Our Mission

To Develop and Nurture the Organization Through:

  • Identification of and Focus on Core Competencies
  • Development of People With Requisite Expertise in Core  Competency Areas
  • Continuous Improvement in all Segments of the Organization
  • Value Added Research Through Collaboration, Tie-ups, Building In-house Expertise
  • Effective Benchmarking With Global Standards

QUALITY POLICY

“We pledge to dedicate our entire efforts to:

  • Produce healthcare products to be used by a continuously widening customer base covering all strata of the society
  • Produce speciality products which are economically manufactured and made available at affordable prices
  • Continuously improve our assurance system to ultimately reach an international level
  • Ensure our fellow human beings are relieved of disease and discomfort”

SAFETY POLICY

We pledge to:

  • Manufacture healthcare products using procedures that protect the   health of individuals and the surrounding environment
  • Create an environment which shall facilitate the working with proper equipment, adequate training and supportive back-up so that each individual shares the responsibility of safeguarding environment, health and safety.
  • Conduct safety audits and share the findings with reference to conformance and adopt necessary measures to clear the non-conformances
  • Review the Environmental, Health and Safety policy, measure performance and reward exceptional achievements

DCI Pharmaceutical Pvt. Ltd. is strengthened with competent employees and sophisticated instruments & machineries. Various departments that operates includes,

  1. Administration office
  2. Manufacturing department
  3. Packing department
  4. Quality department
  5. Store department
  6. Utility area

ADMINISTRATION OFFICE

Administration office

1

MANUFACTURING DEPARTMENT

The manufacturing unit has three manufacturing sections viz. Ampoule manufacturing section, vial manufacturing section and ophthalmic manufacturing section. Entries to these sections are restricted. All areas are accessed through air locks. The areas are categorized in three classes viz.

The manufacturing unit has a state of the art Parenterals manufacturing department categorized in to three units

Manufacturing department ophthalmic section

Corridor of ophthalmic section

2

Ophthalmic Manufacturing Area

3

Ophthalmic Filling Area

4

Manufacturing department Vial section

Corridor of Vial Section

5

Manufacturing area of Vial section

6

Filling area of Vial section

7

Manufacturing department Ampoule section

Autoclave I (Ampoule Section)

8

Autoclave II (Ampoule Section)

9

Ampoules manufacturing Area

10

Ampoules Washing Machine & Sterilizing Tunnel

11

Automatic 8 head Ampoules Filling Machine

12

PACKING DEPARTMENT

Ophthalmic Section

Ophthalmic Packing Machine

13

Vial Section

Vial Packing Machine

14

Automatic Bottle Sticker Labelling

15

Automatic Cartonating Machine

16

Ampoule Section

Automatic Ampoule Visual Inspection Machine

17

Automatic Ampoule Sticker Labelling Machine

18

Ampoule Blister Pack Machine

19

STORE DEPARTMENT

Under test area

20

On test raw material

21

Lift for packing material

22

Approved materials storage

23

Raw material sampling area

24

Dispensing area

25

Under test Packing Material

26

Approved Packing Materials

27

QUALITY CONTROL DEPARTMENT

The manufacturing unit has its own Quality Control Laboratory, which is well equipped with highly sophisticated automatic instruments like HPLC, FTIR, UV-VIS Spectrophotometer, Auto Titrator, Karl Fischer instrument etc. It has facility for microbiological analysis and Endotoxin Testing (LAL). Quality Control Department analyses all the incoming raw materials, packaging materials, conducts inprocess quality control, analyses all the batches of the finished products both chemically and microbiologically, wherever applicable. Stability tests are conducted as per ICH guidelines.

Quality Control Laboratory Chemical Section

28

Instrumentation Section

UV-VIS Spectrophotometer

29

FTIR

30

Auto Titrator

31

Karl Fischer Instrument

32

HPLC

33

Stability Chambers

34

Microbiology department

Microbiological testing is performed under Laminar Air Flow equipped with HEPA filters. The microbiology area is categorized in two classe viz. Class 100 and Class 10,000. The entry into microbiology section is restricted. The testing areas have access through air locks. There is separate testing area for sterility testing and other microbiological testing. Autoclaves are used for sterilization of glassware, media, accessories and decontamination of used media.

Autoclave

35

Laminar air flow cabinet

36

Control sample area

Control sample room

37

QUALITY ASSURANCE DEPARTMENT

Quality Assurance section involved in implementation of good manufacturing and good laboratory practices. Its other functions include inspection of sanitation processes, general cleanliness, personal hygiene, process validation, calibration of instruments/equipments and preparation of SOP / MMFM / BMR and other documentation as well as carrying out IPQC checks in production and packing operations.

QA office

38

computer room

39

documentation room

40

UTILITY AREA

DM Water System

DM Water System

41

The plant consists of the following:
1.Multigrade sand filter
2.Activated charcoal filter
3.Cation exchanger
4.Anion exchanger
5.Mixed bed exchanger
5-micron filter
6.UV Lamp

DM plant has installed capacity to generate 1.5 M3/hour of DM water .The D.M. water after being irrigated by U.V. rays is collected in a D.M. storage tank having a storage capacity of 1000 litres. The manufacturing areas receive D.M. Water, which is pumped from the D.M. Water storage tank and passed again through a 5-micron filter. D.M. water is under continuous circulation from the storage tank to the manufacturing areas via loop.

In addition to above, the D.M. water storage tank supplies D.M. water to the distilled water plant.

WFI Water System

WFI water system

42

A four column distilled water plant using Finn Aqua technique is installed on the second floor of the injection building. The installed capacity of the plant is 150 litre per hour .The D.M water is collected in a surge tank of 250 litres from where it is preheated before reaching the first column. The column generates pure steam of infeed D.M. water, which is further condensed in the next column. The process continues in the remaining columns and pyrogen free distilled water is collected in 2000 litres jacketed storage tank. The temperature of the distilled water at the collection point is about 95°C and conductivity should be less than 1µScm-1. The distilled water is pumped through the storage tank and is passed through a 5-micron filter before reaching the user point via loop. The distilled water is kept at a temperature above 80°C by freshly generated distilled water and it is kept under circulation throughout the day. At the end of the shift the remaining distilled water is drained out.

Pure Steam Generator

Pure Steam Generator

43

Diesel Generator (D.G.) Set

Diesel Generator (D.G.) Set

44

Effluent Treatment Plant (E.T.P) System 

E.T.P.

45

Air Handing Unit (A.H.U.) System

AHU

46

AHU

47

OUR PRODUCTS

For more details logon to www.dcipharma.co.in

MANUFACTURING UNIT

Address : M/s DCI Pharmaceuticals Pvt.Ltd.Vidhyanagar, Margao – GoaIndia 403 601
Website : www.dcipharma.co.in
E-mail : dci@dcipharma.co.in
Tel : +91- 832- 2750582
Fax : +91- 832- 2750584
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