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| Premises |
| The plant is mainly divided into different sections. |
- R.M. Stores
- Liquid R.M. Stores
- Packing material stores
- Bottle Stores
- Bonded Store Room
- Module -I for Creams/Gels.
- Module -II for Mouth wash/ external oral liquids
- Module -III – Liquid Orals like Suspensions and Syrups.
- Module -I and Module -II common packing hall with aluminum partition.
- Module -III packing hall.
- DM water storage area.
- Quality control Laboratory along with separate microbiology section.
- Decartoning area.
- Sugar storage area.
- Other areas are Utility section, LT room, DG room, Maintenance,
service area, DM plant room, Dining hall, Security room, Kitchen.
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| Plan of manufacturing area – Annexure II (A,B and C) enclosed. |
| Man movement – Annexure III enclosed. |
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| Brief Description of each Production Area : |
- Module I is divided into three sections.
- Manufacturing area covering 47.383 sq.mtrs.
- Tube filling and sealing area covering 18.375 sq.mtrs.
- Washing area covering 5.75 sq. mtrs.
- Module II is divided into four sections.
- Manufacturing area covering 40.068 sq. mtrs.
- Bottle washing area covering 20.295 sq. mtrs
- Filling and Sealing area covering 34.27 sq. mtrs.
- General Washing area covering 20.228 sq. mtrs.
- Module III is divided into three sections.
- Manufacturing area covering 46.256 sq. mtrs.
- Washing area covering 24.75 sq. mtrs
- Filling area covering 21.83 sq. mtrs.
- Module I and II packing area is of 77.855 sq. mtrs.
- Module -III packing area is of 70.80 sq. mtrs.
- DM Water storage area is of 27.82 sq. mtrs.
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| All main areas are separated from each other by 2.40 mtrs. wide corridor. |
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| Nature of Construction and finishes |
The production area and Packing areas are constructed under the supervision and guidance of a Chartered Engineer. The nature of construction is RCC. The building is constructed on pillars. The walls are built with bricks to absorb sound and reduce the noise pollution. All the walls are plastered with cement to get smooth finish. All the corners are coved to avoid dust accumulation.
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The flooring is finished with epoxy/ Polyurethane coating to facilitate easy cleaning and disinfection. In core areas like walls in production area are painted with polyurethane paint and the corridors with luster paint to facilitate easy cleaning and disinfection and to protect walls from water absorption. All the doors are double glass flush aluminum doors, purpose being to avoid dust accumulation and facilitate easy cleaning.
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cGMP drains are provided in critical areas and the pipelines are concealed.
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| The service pipelines like steam, air, raw water, DM water etc are dropped into rooms through pendants. Electrical lines - major portions run in walls and are concealed and wherever necessary they are run in SS conduits. All the product transfer lines are hanged to the ceiling. |
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| Brief description of ventilation system |
| Our Manufacturing and Packing premises is well ventilated and proper lighting is achieved by providing glass windows through out the premises. However sufficient tube lights are provided to have required lighting levels. Emergency lights are also provided in case of power failure. |
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| The air ventilation is achieved by providing Air handling unit. All three modules will have independent air handling unit, to achieve required temperature and air quality standards of class 1,00,000 by using HEPA filters in the AHU. The entry corridors are also ventilated to class 1,00,000 conditions. Service floor is provided in the building on the first floor level for AHU’s and ducts are above the false ceiling. |
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| Air handling unit is made of MS powder coated sheet metal cabinet in double skin modular construction. |
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| This system is divided into three groups. |
- Air Handling system with temperature and humidity control and class 1,00,000.
- Ventilation system without temperature control & class 1,00,000.
- Ventilation system without temperature control & 5 micron air.
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| Manufacturing, Filling and sealing area is provided with temperature and humidity control system, remaining area has only temperature control. |
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| Each recirculation AC system will have 10% to 15% fresh air filtered through 20µ filters. Ventilation system consists of supply and exhaust air blowers. |
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| All areas are covered either by AHU or ventilation system. |
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| AHU & Ventilation system is broadly divided into 4 groups. |
- Fresh air A/c supply system with class 100000 having 10µ, 5µ, 0.3µ
filters in AHU.
- Fresh air A/c supply system with class 10000 having 10µ, 5µ, 0.3µ
terminal filters.
- Fresh air supply system with 10µ and 5µ & 0.3µ filters to get class
1,00,000.
- Fresh air supply system with 10µ & 5µ filters.
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| Exhaust system are fitted with 20µ filters on discharge side for ventilation system. |
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| In system controlled area the temperature is 25oc + 2oc and maximum humidity is 75%. |
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| In other areas the temperature is 35oc + 2oc and maximum humidity is 75%. |
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| In manufacturing and Filling, sealing area Air changes are 30 per hr. |
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| In other areas, Air changes are 25 per hr. |
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| The air handling system is validated. All the validation reports are documented. There are written procedures for cleaning of filters and operation of AHU. |
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| Ventilation System Layout – Annexure IV (A & B) enclosed. |
| Brief description of water system |
| We receive water from KIADB Water Board. |
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| There are 4 water storage tanks. |
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| Two under Ground tanks are of capacity 25000 ltrs each and one overhead tank is of capacity 20000lts. These tanks are built by RCC. Walls, Floors and Ceiling are plastered with cement and treated with anti Algae chemical to get smooth finish, which does not allow formation of any algae and is easy to clean. |
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| Another overhead HDPE tank has capacity of 2000 ltrs. |
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| The entire transfer pipelines are of GI (Galvanised Iron) material. It is painted with green colour for raw water identification. |
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| The water received from KIADB is stored in Ground water tank –I. From tank I water is passed through multigrade sand filters having a capacity of 8500 lts/hr. This filtered water gets chlorinated online by sodium hypochlorite solution. |
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| This chlorinated water is collected in Ground Water Tank II. From Tank II water is pumped into overhead tank-I and from here it gets distributed into process and domestic needs. There are written down sanitation programs for water collection and distribution system. |
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| The process water is produced by DM water system. This consists of Activated Carbon Filter, cations, anions and mixed bed, 5µ filter and then the water is passed through uv chamber before it reaches the two 4500lts storage tanks. The water from here is kept in continuous circulation by using cold loop distribution system. |
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| The distribution system is made of SS electro polished seamless pipes. Water produced from the DM water plant is analysed daily for chemical parameters and for microbiology. Water is collected daily from storage tank and frequency of testing will be as per written procedures. All the sampling points and frequency of testing based on Phase I, Phase II, Phase III are specified in written documents. The procedure and frequency of sanitation and passivation of DM water distribution system is as per specific SOP guidelines and is recorded in respective departments. |
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| Water distribution system – Annexure VA (Water Flow Chart) and VB(DM Water distribution loop system) – enclosed |
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| Effluent Treatment |
| The plant has an efficient effluent treatment plant to treat the effluent of solids and liquids containing both inorganic and organic material. |
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| The process effluent generated from the unit is conveyed through closed drain system to Effluent Treatment Plant (ETP) by gradient. The wastewater from domestic activities (toilets, canteen, etc) is connected to septic tank and over flow effluent is connected to ETP. |
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| The method adopted for treating this combined effluent after flow equalization, is aeration and biological. This process is followed by filtration and on line chlorination. The treated effluent is discharged on to land for gardening as per the norms stipulated by the statutory Pollution Control Board. |
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| Maintenance |
| Description of planned preventive maintenance programmes for premises and recording system : |
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| The premises maintenance schedules are clearly drawn and are followed on day-to-day basis and are recorded. The preventive maintenance is defined for day-to-day, weekly, fortnightly, monthly and annual activities. This whole program is followed as per the guidelines envisaged in the relevant SOP’s. Other activities are as follows: |
- Prevention of Fire accidents in the premises :
Fire extinguishers are installed in the manufacturing areas, stores, lab. Sand buckets are provided at DG room, Panel Board Room and other areas wherever required.
In fire extinguishers, cartridges are replaced and serviced every year and records are maintained. Training has been given to all employees on how to use fire-fighting equipments. Written Fire extinguishers SOPs are displayed.
- Pest / Rodent Control
Pests and rodents are treated as per the norms and requirements identified by expert staffs in this line. The pest control activity is done once a month and rodent control activities – once in fifteen days. The necessary records are entered. There are SOP’s for pest/rodent control.
- Rust Control
All the walls, steel frames, doors and windows will be painted once in a year or earlier if required to avoid any rust or cracks etc.
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| Equipment : |
| All major production equipments are made up of SS 316 material. All equipments are designed in such a way that it facilitates easy cleaning. The main equipments are 2500 ltrs manufacturing tanks, 1600 manufacturing vessel, 2000 Ltrs sugar syrup vessel, 600 Ltrs C.M.C. dispersion vessel, 1200 & 500 ltrs capacity storage vessels, filter press, heating jacketed kettle, 64 head bottles washing machine, 4 head filling machine, 8 – Head Mono block filling & sealing machine, Automatic cap sealing machine, bung pressing machine, sticker labeling machine, Gum labeling machine,1000 ltrs. Capacity-Creams and Gels manufacturing vessel, 60-80 per minute tube filling and sealing machine, overprinting machine, Ink jet printer etc. |
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| All the major equipments are validated; the protocols and reports are documented. Written operation and cleaning procedures are displayed near the machines. All the equipments are designed in such a way that it facilitates easy cleaning. |
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| Batch coding machine is designed in such a way that the batch number details are printed on labels online and then stickered onto bottles/vials. |
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| The Tube filling machine is designed in such a way that the batch number details are coded on tube while sealing of the tubes. |
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| All the service lines from their origin to the final destination are colour coded based on the service it renders. The colour-coded index is also displayed at all relevant locations. |
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| Equipment Layout Drawing – Annexure – VI (A and B) enclosed. |
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| List of Manufacturing Equipments – Annexure – VII – enclosed. |
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| Quality Control Laboratory |
| Quality Control Laboratory has critical instruments, such as uv spectrophotometer pH meter, conductivity meter electronic balance. The entire instruments are qualified for installation, operation and performance qualification. The critical instruments, have calibration schedule, as per which it is periodically calibrated. |
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| List of Quality Control Instruments – Annexure VIII – enclosed. |
| Microbiological Specifications |
| Microbiology section is fully equipped with all necessary instruments to carry out the testing of Raw materials, Packing materials, Finished products, water and air samples, The department has the following instruments/ equipments: Autoclave, B.O.D Incubators, Incubators, Refrigerator, Laminar air flow unit, Air sampler, colony counter, microscope. There are written down documents for validation and calibration of the above instruments/ equipments. There are PPM schedules for all and the activities are recorded in respective formats. |
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| Preventive Maintenance for equipments |
| We are having a separate maintenance department in our site. The department will be doing day-to-day maintenance work of all equipments including other maintenance work. |
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| Equipments are still having warranty period hence we have not contracted any other external servicing agencies for maintenance. In case of major break down of the equipment, we contact the manufacturer. |
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| We have written SOPs for all the equipment preventive maintenance with schedule so that our product quality is not affected. Equipment maintenance is performed regularly, which does not affect the product quality. |
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| After completion of maintenance work, the maintenance department informs the respective departments and records are maintained. |
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| Qualification, validation and calibration : |
| The instrument / equipment when purchased for production or quality control should be validated and then the instrument / equipment is allowed for regular use. Validation may be defined as a means to prove that an equipment or process actually performs as per the design for which the instrument / equipment is fabricated for its intended purpose. |
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| The purpose of validation program is designed to have better control of manufacturing and related operations to ensure minimum deviations in actual production. |
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| Validation protocols are based upon documented systems involving a team of personnel from production, engineering and quality control. All Protocols are written, defining the process, critical parameters and their measurement attributes. Any change or deviation made in the validated process or equipment or instrument that is critical will be revalidated. |
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| Analytical test procedures |
| The validation of an analytical test procedure will be demonstrated by repeatability of required accuracy, precision, specificity, sensitivity and ruggedness of the method based on written procedures. |
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| Instruments |
| All measuring devices are calibrated, as this is critical for controlling the process. Instruments calibrated include thermometer, Pressure gauges, hygrometers, conductivity meters, temperature gauges, other digital displays and weights. They are calibrated periodically as per the calibration schedule internally and also by external agencies. |
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| Calibration is done for instruments wherever required like Spectrophotometer, pH meter, conductivity meter, balances etc. Calibration is carried out as per written procedures and all accessories used for this purpose will have traceability to the recognized national standards wherever possible. |
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| Equipment |
| All the equipments like manufacturing vessels, storage vessels, bottle washing machine, turn table, filling, sealing and capping machine, labeling machine are all validated as per written protocols for DQ, IQ, OQ and PQ. |
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| Facility design |
| The facility is constructed as per cGMP norms. The design, construction, operation, on going Maintenance, planned preventive maintenance of the facility is monitored. Flow of material and personnel is unidirectional and avoids cross contaminations. Area and equipments is designed keeping in mind all parameters like cGMP norms, safety and efficacy. Drawings and written specifications are available for all equipments. SOP’s are displayed for operation, cleaning of equipments and for facility maintenance. |
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