We at Cambridge Health Care Limited are committed to ensure the delivery of quality products as per the standard specified by different regulatory/certification bodies which will consistently satisfy and also their implied needs by:

• Making quality products to the changing requirements for the customers.
• Product profile i.e. type of the products.
• Continuously improving process, planning production and delivery.
• Approach to total quality management.
• Identification of the market segment to be served and intention of satisfying customers..
• Involvement of employees in the quality building effort.
• Compliance with statutory, environmental, health and satisfaction.
• The quality policy is designed to ensure customers satisfaction.
• Offering value for money.
• Quality is best policy. Here quality is a habit.

Infrastructure.

Area 20500 sq. Meter, good internal bitumin roads and greenery area of our factory.

1.SHORT DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM

At Cambridge Healthcare Limited quality management system is in accordance with WHO GMP standard requirements, documented, implemented, maintained and continually improved. Ensure that the product confirms to specified requirements. This includes the preparation and effective implementation of documented quality assurance procedures, which are in accordance with the current Good Manufacturing Practices (WHO GMP) requirements.

2. BRIEF DESCRIPTION OF WORK: -

Quality Control & Quality Assurance Department:

• Quality control activities
• Testing and documentation as per WHO GMP.
• Calibration maintain of instruments.
• Responsible for production and productivity of the plant
• Supervise manufacturing and packing as per WHO GMP.
• Coordinate with Drug Control Authority
• Operate Computer for related work of production department
• Responsible for in -process control in production Dept.
• Responsible for Quality Assurance Activity.
• Validation for QC and Production.

Production & Manufacturing Department:

• Responsible for production and productivity of the plant.
• Supervise manufacturing and packing as per WHO GMP.
• Coordinate with Drug Control Authority.
• Operate computer for related work of production department.

Logistic Department:

• Coordinates the purchase of raw materials and packing materials.
• Procurement of Raw materials for food products from Govt. of Gujarat.
• Coordinating vendors.
• Preparation of store documents as per c-GMP norms.
• Inventory control.
• Preparation of reports as per the rolling requirement.
• On the basis of the rolling requirements make the indent and purchase order.
• Dispatching finished goods.
• Handling store auditing system.
• All other routine work as well as the statutory requirements.
• Managing pest control in factory.

Maintenance Department:

• Day to Day maintenance.
• Preventive maintenance.
• Environment and control.
• Running and preventive maintenance of boiler.
• Maintenance of DG set.

3. PREMISES AND EQUIPMENTS: -

The company has separate manufacturing facilities for different type of products .For every machine separate cabin, separate A.H.U. is provided to prevent cross contamination. Air conditioning and dehumidification system is provided for handling moisture sensitive products. Separate workers entry, raw material store, quarantine store, washing section is provided as per recent GMP guidelines. Refreshment rooms and toilets are separate from the other areas. Facilities for changing cloths and for washing and toilet purposes are separately provided for males and females. It is appropriate for the number of users. Maintenance activities are separated from the production areas. Machine related parts and tools are stored in a separate room of the production areas.
4.DETAILS FOR PLAN AREA: -

Sheet No.	Plant Code	Function	Area in sq.mtr.
1	1	Factory site, Mehsana	20350.00
2	2	Main Formulation Block	2094.00
3	2.1	Canteen Block / Welfare Block & Inter connection Canteen & Formulation Block.	325.00
4	3	Electrical Substation/ Refrigeration plant/ Workshop	148.00
5	4	Boiler House	56.00
6	5	Water Treatment Plant	121.00
7	6	Gate House	9.00
8	7	Bicycle, Scooter stand	87.50
9	8	Car park	42.94
10	9	Ware house	900.00
11	10	Quality Control Block	250.00

5. PARTICULARS CONCERNING THE DIFFERENT AREAS: -

5.1 Quality Control:

Quality Control Laboratory is well equipped with some modern instruments and analytical method to control and ascertain the quality of the product, during production as well as in the finished pack.
All Instruments necessary to perform analytical test, microbiological test are available with Cambridge Healthcare Limited.

5.2 Quality Assurance:

Quality Assurance Section is equipped with sufficient documents, periodicals review of product, APR, Stability data and standard operating system is being established. The department is effective at all the levels of manufacturing.

5.3 Storage:

Raw materials, packing materials and finished goods are stored in separate areas for release and quarantined materials and products are stored according to the requirement norms of Good Manufacturing Practice(WHO GMP).
As per WHO GMP norms we have Sampling and Dispensing booth in dedicated area.

5.4 Maintenance:

Facilities and equipments are maintained and kept in good working condition. Mechanical and Electronic testing equipments are checked, calibrated at suitable intervals according to the requirement of Good Manufacturing Practice (WHO GMP).

Utilities:

1. Steam
2. Electricity
3. Raw Water
4. Soft Water / Dematerialized water
5. Compressed air
6. Diesel Generator Set
7. Air Handling Unit / HVAC systems
8. Ventilation system.

6. Electricity : -

630 KVA Transformer ( Uttar Gujarat Vidyut Co. Limited).

In absence of Electricity supply we have sufficient capacity D.G. Set of 380 KVA.
7. Water : -

We have sufficient capacity RAW water for boiler and routine work.
Also we have Distilled Water plant for Analysis and Equipment Cleaning purpose.
8.Pest Control: -

Pest and rodent control :

Pest and rodent treatment is to protect the drug and other material from rats termites and rodents. Schedule for termite control is carried out fortnightly ,which is carried out by the pest controller. Treatment controlling the pest in specified area is done at key locations in welfare blocks, external periphery & Stores. Treatment for controlling the rodents, lizard, insects in the specified area is done regularly and records are maintained.

9. Air Monitoring: -

Details of ventilation systems :

The building is well ventilated, separate exhaust fans are provided at different locations in such a manner that the exhausted air does not contaminate other areas. Separate ducts are provided wherever required. The areas having potential risk of cross-contamination/ microbial growth are provided with AHUS Separate AHU are provided in different areas.

Separate AHU's – HVAC are provided in manufacturing areas & packaging areas with required differential pressure to avoid any cross contamination. Also we have provided ventilation systems (pre filter air) in store and production area,where it is required.
10. Stability Testing Facilities: -

CAMBRIDGE HEALTH CARE LTD., have stability (long term/accelerated) facilities as per ICH guidelines to evaluate Drug Product and Drug Substance Stability.

To support these activities, Cambridge offers full Analytical Method Development and Qualification, Validated Stability Chambers at all storage conditions and a Laboratory Information Management System (LIMS) for complete sample and Document Management.

Business and Registration: -

International Business

Cambridge established in 1995, is one of the leading pharmaceutical company, originating from Mehsana (Gujarat) India and having completely satisfied customer network at more than Twenty countries, some of them are Florida, Bangladesh, Myanmar, Philippines, Zambia, Congo, Kenya, Chile, Botswana, Malawi, Costa-Rica, Bolivia, Mozambique, Thailand, Sri Lanka, Nepal, Nigeria, Afghanistan, Malaysia, Vietnam, Bhutan, Peru, Ecuador, Venezuela and many more.

We are serve our customer with own brand Establishment, In Licensing, Loan License for MNCs / Indian MNCs and Contract manufacturing.

Registration

All the registration processes and dossier preparation system followed in house by our technical team. We are going for international accreditation in next era for business expansion.