Quality Control

Quality Calibration - A Committment Quality Control Mechanism
Minopharm Documentation Safety Measures
Steps taken for Pollution Control Modernisation

Quality Calibration - A Committment

Minopharm manufactures QUALITY PHARMACEUTICAL FORMULATIONS in the form of Tablets, Capsules, Liquid orals and injectables with QUALITY MANAGEMENT in order to emphasise the relationship and fundamental importance to the production and control of pharmaceutical formulations.

The company gives top priority to QUALITY MANAGEMENT in which Quality assurances, GMP and Quality Control are interrelated aspects. All the Plant & Machnery in the unit are designed as per the latest state of the art Technology.

Committed to qualit and safe drug production with all assurance the company levies a great duty and care on hygiene standards and maintenance. Expert, qualified personnel, with a meticulous inch-by-inch care, monitor every stage in the integrated process. All the neccessary controls from raw ingredients to the finished products are accurately processed and checked for quality at different stages in accordance to the defined procedures. The micro biological, physical and chemical levels are made to conform to the prescribed WHO-GMP guidelines and specifications.

Quality Control Mechanism

Quality control at MINOPHARM is an important concern with sampling specification and testing as well with the release procedures, documentation with its application to the entire organization.

The quality control department of the MINOPHARM validates the control procedures to maintain the reference standards in the company. It carries self-inspection to evaluate the product compliance with GMP in all aspects of production and submits a report on the corrective actions/remedial actions to be followed up.

Minopharm Documentation

The company gives utmost importance to good documentation and its aim to define specifications for all materials and methods fo manufacturing and Quality Control to ensure that all personnel concerned with manufacture to provide an audit trial that will permit investigation of the history of any suspected defective batch.

The company documentation is maintained as per schedule M of the “Drugs and Cosmetics Act, 1940. The written procedures, methods describing the manufacture, marketing, quality control and other operations are wel articulated and maintained. The documentation, recording and registering systems at MINOPHARM help a diligent smooth functioning of the company.

Steps taken for Pollution Control

Minopharm is located in a 1 Acre plot on Ongole – Kurnool road with high rise and spacious buildings with a built up area of 20,000 sq. ft. The remaining area is used as open space, where plantations, lawns are raised. More than 100 trees have been planted on the campus to increase the greenery in the area. We had received the Consent from the pollution Board for Air and Water pollution and Noise Pollution is not applicable to our industry.

The sources of Air pollution in our unit are very mild but still utmost precautions are taken to control the same. All the manufacturing sections are equipped with the best Air handling and ventilation systems where the outside is pumped into the production areas after passing through 5 micron filters and the polluted air inside the unit are passed through bag filters before leaving them into the atmosphere. These filters bags are regularly cleaned and a Standard Operating Procedure is followed for this maintenance and effective records are maintained.

As a Pharmaceutical formulation unit we are orange category unit classified, we don’t release any harmful effluents or water because we don’t use any hard chemicals in our manufacturing processes

The reject water from reverse osmosis plant and from the production area will be collected in separate tank and used for floor washings and green belt development. We had even utmost preference for the development of green belt in and around the factory and the waste water collected after the process is used in this development.

There is no noise pollution in our unit because we don’t operate any high grade motors and compressors. However wherever small motors and compressors are there guards are mounted adequately to ensure the reduction of noise and vibrations.

We maintain hygienic environment in the plant premises inside and outside the manufacturing areas. Established consistent procedure for better house keeping and sanitation to avoid infection to personnel and product contamination.

White colour aprons, nose masks, hand gloves are provided for all the in charges in shifts and to the analyst in quality control department.

Pest control and rodent control activities are carried out periodically in raw materials stores, packing materials stores, finished product stores and other areas. Drains are cleaned periodically to avoid blockages and deposits at production areas, effluent treatment, utility areas etc.

Safety Measures

All the machines are provided with Safety Guards with all the measures to be adopted in the manufacturing premises.

All the workers are provided with Masks, Caps and Safety shoes in all the departments.

Fire Extinguishers are provided at all Critical Areas in the factory and the personnel are trained ways and means to escape in the event of fire out break. In case of fire break out emergency torches are provided at all places.

Safety hand gloves are provided for handling materials and equipment.

All the personnel have engaged in Production Control are subjected to medical regularly to ascertain their Medical Fitness. Twice in a month, Medical Officer visits our unit to ascertain the fitness of the employees.

The safety measures are written as Standard operating procedures where it is mentioned what are the measures to be taken at every department and machines. All the technicians and personnel are trained to these SOP's and we make sure they follow them without fail.

Modernisation

The following steps have been taken for modernization of the enterprise

We had modernized the new sections for manufacturing of B lactum tablets and Capsules sections. For modernization of these sections we had installed clean room panels, state of the art facilities required for the manufacturing.

We have installed the State-of-the-art Plant & machinery in all the sections on very regular basis.

The State-of-the-art equipment required for in house testing facilities in Quality Control department had been modernized by installing with latest HPLC system, GLC system and also with other few types of equipment.

The quality control laboratory is modernized with the addition of the Microbiological facilities, the microbiological testing equipments are added and now we are fully equipped for in house testing facilities in microbiological section.

We had modernized the Advanced Technology in Blister Packing machines and added few machines in the packing section.

Now as part of modernization programme most functions are operated through electronic data processing.

As a regular part of the modernization programme we are conducting the training sessions in GMP practices and systems

As a part of continuous modernization we are adding latest technologies for product design and manufacture.
We had added Clean room panels in the required sections.

As a part of the modernizationair handling systems are installed through out the unit with Central Air conditioning to have 5 micron air flow into the unit.

OUR MOTTO:
“Wealth Health for a Healthy Wealth”;
Minopharm Laboratories Limited
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