Shine Pharma
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OUR COMPANY
  a Site Description
  a Premises
  a Plant Features
  a Quality
  a Air Handling System
 
Awards & Certifications
  Award

WHO GMP AND ISO-9001-2000 Certification by KPMG

 

Site Descriptions

Company

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It is a Pharmaceutical Formulation unit situated at Karjan, near National Highway No. 8, 34 kms away from Vadodara city, in Gujarat State.

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Land Area: 25000 sq. mtrs Even though the factory site is surrounded by farm land from three side, however to avoid the dust pollution we have made the factory building on window less concept. It is free from dust, smoke, chemical and biological pollution. There are no pollutant industries or activities surrounding the unit.

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Built-up Area: 4500 sq. mtrs with new construction as per Schedule M and WHO guidelines.

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No other manufacturing activities are carried out in factory premises.

Premises

The company has constructed the factory building as per the latest WHO GMP standards and the each department has been constructed in such a way so as to allow each operations to flow in Uni Direction. All the Doors & Viewing Panels are of Aluminum and the Doors in the production area are double Flushed. The Flooring is of Kota Stone with Mirror Polished and the Walls are Oil Painted. The building has been constructed with Windowless Concept so as to avoid any kind of pollution.

Capacity - Per annum

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Tablets Department : 400 Million Tablets

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Capsule Department : 120 Million Capsules

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Liquid Oral Department : 10 Million Bottles

Salient Features of the Plant

Process

Process

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Plant located in pollution free surrounding

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Facility for various types of dosage forms

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Segregated men & materials entries

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AHU/Air Compressors are located outside the Factory building on the East side

arrow 23 independent Air Handling Units for effective segregation of processes and products
arrow Dedicated areas based on product categorization
arrow Awarded ISO 9001-2008 certification
arrow Awarded WHO GMP certification

Quality - Our Promise

qualityThe company has constructed the factory building as per the latest WHO GMP standards and the each department has been constructed in such a way so as to allow each operations to flow in Uni Direction. All the Doors & Viewing Panels are of Aluminum and the Doors in the production area are double Flushed. The Flooring is of Kota Stone with Mirror Polished and the Walls are Oil Painted. The building has been constructed with Windowless Concept so as to avoid any kind of pollution.

 

The role of Quality Assurance is to develop and maintain the Company's Quality Procedures and systems through a combination of sampling, testing, monitoring, stability, validation and the release of only tested and approved products. At every stage and each processes are controlled according to stringent international standards ensuring to meet expectations and specifications at all times.

 

Authorised Standard Operating Procedures are adhered to for materials management, production, storage and distribution, safety, housekeeping, sanitation and engineering. Suppliers of materials are assessed for conformance with GMP. As a continuous practice, we check, revalidate and upgrade our technology to keep pace with global quality standards.

 

Air Handling System

Company

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Total 23 AIR HANDLING UNITS, according to the requirements of different production departments are installed to ensure fresh, filtered and 1 Lac class air flow in the manufacturing area.

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HVAC systems have 10 micron pre-filter , 3 micron fine filters and Finally HEPA filters at the terminal and the same are AHU plenum mounted filters and the filtration class maintained is class 1,000,00 (Class 1 Lac)

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The number of air changes per hour in the manufacturing area is 25 & adequate fresh air (around 10%) is taken in to make uo the loss in air volume during circulation

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The design has been developed to maintain a temperature of 23 +/- 2oC and RH of around 40 in the manufacturing area.

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The factory passage is a pressurized corridor with Positive pressure to prevent cross contamination.

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The filters are periodically cleaned as per the SOP.

arrow Validation of the AHU and Ventilation system has been done as per SOP.
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