About Us

Use of Outside Scientific, Analytical or other Technical Assistance in Relation to Manufacture and Analysis.

The company has appointed a well experienced consultant to advise on the matters of c-GMP. He makes regular visits to the factory for inspection, advises and training on GMP.

The samples of Raw Materials and Finished products, requiring analysis by sophisticated instruments, is being sent for analysis to below mentioned approved public laboratories.

• The Gitar Laboratories – Ahmedabad.
  
• Altra Analytical Services – Ahmedabad.
  
• Oasis Test House – Ahmedabad.
  
• Vaibhav Analytical Services – Ahmedabad.

• The company is committed to total quality management. The company has laid down strict quality norms through out the operation of each activity. The company has selected vendors of repute for Raw Materials and Packing Materials.
• A goods receiving note is prepared for each supply of materials and a copy of which is immediately forwarded to the Q.C. Department for further sampling etc. The material received is immediately be recorded in stock register.
• The material received is first be kept in Quarantine Area with label indicating UNDER TEST on each container as per the S.O.P. of the same. The sampling is being done in separate area to avoid cross contamination by the Q.C. Departmentin accordance with S.O.P. for drawing samples of various materials. The samples are being tested by the Q.C. Department for the compliance of prescribed specifications.
• The materials which will be approved by the Q.C. Department are to be labelled “APPROVED” by Q.C. Department and these materials are being transferred to Tested Material Store.
• The dispensing of Raw Materials is done in a specific area maintaining the room condition as specified in S.O.P. All precautions in respect of temperature, relative humidity, protection against light (for light sensitive material) and protection against atmospheric oxidation of certain materials will be observed and complied with. Approved materials will be dispensed for use in production on first – in – first – out (FIFO) basis.
• Before starting any manufacturing activity “Line clearance” is being obtained from Q.A. Department
• The manufacturing activity is carried out under strict supervision of approved technical staff, as per the prescribed process mentioned in S.O.P.
• There is a specific provisions for in-process checks by the production as well as Q.A. Department. The particular of in-process checks carried out and results thereof are to be recorded in Batch Manufacturing Records. (BMR).
• The bulk creams, ointments, lotions, etc. are being tested for compliance with the prescribed specifications before their primary packing. The finished products are being tested as per the specifications before they are released for the dispatch.
• All equipments in the manufacturing area are to be regularly cleaned as per the validated cleaning methods.
• The company has a well equipped Quality Control Laboratory. The equipments in the laboratory are being validated at regular intervals. The instruments in the laboratory are being calibrated at regular intervals as per the S.O.P. Proper records are being maintained for all validation and calibration.
• Self Inspection is being carried out by the internal audit team. The discrepancy if any, revealed in the audit report, are to be rectified.
• The Q.A. Department has to be scrutinize each BMR and the products are to be released for dispatch only after receiving Q.A. release.
• There is well defined procedure for handling product complaints and records thereof are to be maintained.

Products Details Registered with Foreign Countires :

At present company has not registered any product with foreign countires.

PERSONNEL

Organizational Chart.

Please refer to Annexure – I for the ORGANOGRAM.

Qualification, Experience and Responsibilities of Key Person.

Production Manager.

Mr. Dharmedra Patel is holding the responsibility of production manager and hereports to the Director ( Tech.). He is a B.Sc and is having a total experience of around 10 years in the various activity related to Pharma Formulation. He is approved for Ointment & External liquid mfg. by FDCA, Gujarat State.

Quality Control Manager.

Mr. Vijay Patel – B.Sc is a Q.C. Manager and is responsible for the Quality Control. He is having an experience of around 8 years in the analysis of various pharmaceuticals formulations and raw materials thereof. He is approved in Chemical & Physico Chemical Testing by the FDCA, Gujarat State.

Miss.Stuti - B.Sc. (Micro.) is having around 2 years experience of Microbilogical Testing and she is approved by The FDCA, Gujarat State.

Quality Assurance Officer.

Mr.Suryakant Doshi – B.Pharm is looking after all the activities related to quality assurance. He is having reach experience of 25 years.

Store Executive.

Mr.Bhupat Ghadhvi is the incharge of stores of finished goods. He is a B.Sc and possesses around 5 years experience in handling and distribution of finished products. He is well versed with the billing procedure and excise department formalities.

Arrangement of Basic and in Service Training.

The new recruits are to be required to undergo induction training which will be given by the executive incharge of the espective department. The induction training covers basic education in GMP, safety measures and hygiene. After completion of nduction training. the new recruits are to be given `on-the-job’ training. The trainees will be supervised to ensure that they have started following the right practices and have understood the basic job to be done. After successful completion of the `on-the-job’ raining, the employees will be allowed to carry out regular job.

Records are to be maintained for each trainee and the trainee undergo.

Periodical training programmes will be conducted at factory to refresh the basic training .

Employees will be sent to attend various seminars.

Health Requirements for Personal Engaged in Production.

Employees will be medically examined before recruitment. There will be a system of annual medical checkup for employees engaged in production. Employee suffering from any illness will be allowed to resume duties only after obtaining fitness certificate from the company’s approved medical practitioner. All medical reports of the employees will be maintained.

Personnel Hygiene Requirements Including Clothing.

Special attention is given on personnel hygiene and clothing.

Entry into the manufacturing and packaging area is being restricted to authorized personnel only. Employees remove their footwear and wash feet and hands with soap and water and dry the hand and feet after entering the first change room.

In the first change room work men will wear factory uniform and factory footwear. The general factory uniforms are changed daily. The uniforms are being laundered mechanically by approved laundry outside the factory.

The procedure for entry into the production area and the handling of the uniforms are documented in the form of S.O.P., which are strictly complied with.

PREMISES

Description of Manufacturing Areas.

Please refer to the site plan approved by FDCA, Gujarat State, Gandhinagar.

Nature of Construction.

The Factory premises has R.C.C. structure with Brick walls. The false ceiling is of Gypsum Board. The part of the first floor is covered by cement sheets supported by Iron trus. The internal wall surfaces including ceilings have smooth finish. The internal walls have been painted with Synthetic Acrylic paint which facilitates easy cleaning.

The external wall surface are painted with high quality Snowcem cement paint which protects the building from external environment.

The flooring of manufacturing area is covered with epoxy paints and the walls of the said areas are painted with Poly Urethan paints.

The flooring of rest of the areas are of polished Kota Stone which is strong and easy to clean.

Brief Description of Ventilation System.

All the manufacturing areas are equipped with Air Handling Units with 10 micron and 5 micron filters. Room temperatures are maintained at 25 C +/- 2C. Each room is having its own separate A.H.U. System to avoid cross contamination. The A.H.U. System is equipped with dehumidifier in some critical areas.

All primary packaging areas are equipped with Air Handling Units with 10 micron and 5 micron filters. Room temperatures are maintained at 25 C +/- 2C.

Rest all other areas of the premises are provided with Air Handling Units with the 10 micron filters for continuous supply of fresh air.

A schematic diagram of entire A.C. System and Ventilation System is attached separately.

Brief Description of Water System and Sanitation.

The company is having its own overhead tanks to store raw water supplied by Industrial Estate. The raw water is being reated before using in production process. The D.M. water is to be filtered through 10 micron and 5 micron filters and subjected to U.V. treatment.

The storage and transfer system of D.M. water has been made out of S.S. 316 quality material.
The samples of water are to be taken at various points.

Sanitation

All waste water including the sanitary water will be treated in a Effluent Treatment Plant (E.T.P.) The treated water generated after E.T.P. processing is being used for gardening.