Product Development

Product Development

To check and control the quality parameters at all the stages of product development MEDICON PHARMA is equipped with most advanced technology. There are two departments which are responsible for checking the quality parameters of our products and services, namely QUALITY ASSUARNCE DEPARTMENT and QUALITY CONTROL DEPARTMENT.

ACTIVITIES OF QUALIT ASSURANCE DEPARTMENT: QUALITY ASSUARNCE DEPARTMENT is responsible to check and monitor all the factors (other than chemical and microbiological tests) which may affect the Quality of our products and services.

The QUALITY ASSURANCE DEPARTMENT PERFORMS THE FOLLOWING ACTIVITIES: Draw Samples of all types of Raw materials, Packaging components and Finished Products at various stages of product development. The samples of Raw materials are submitted to Quality Control Department for chemical and (if applicable) microbiological testing. The samples of all the products at various stages of manufacturing are drawn and submitted to Quality Control Department for chemical & microbiological testing.

All the processes are being validated by the Validation Section. The IQ, OQ and PQ of all the machines, equipments and processes are being recorded. The Calibration Section calibrates all the equipments of the plant according to the schedule. Calibration of the master calibrators is done from the external sources. The testing of Packaging components is done in the Quality Assurance department.

The Environmental Monitoring of all the area of working is being done in co-ordination with the Microbiology laboratory. The samples of each batch of all the products being marketed are retained for stability testing. The stability of these retained samples is tested after regular intervals. During the first year of manufacturing the samples are tested on quarterly basis. During the second year, test is done 6 monthly and in third year the sample is tested once after one year.
Quality assurance is also responsible for any product to be recalled from market after following the specified procedure.

BATCH DOCUMENTATION AND RELEASE OF FINAL PRODUCTS: The Physical inspection and testing of products at various stages of manufacturing is done by the Physical laboratory In-process control of Quality Assurance Department. The complete testing and release status after each stage is recorded in the Batch Processing Record. After the final packaging of the complete batch the Batch processing record is audited by the QAD and the stock is release for marketing by the Quality Assurance Manager.

ACTIVITIES OF QUALITY CONTROL DEPARTMENT: The QUALITY CONTROL DEPARTMENT is responsible to analyze and check the chemical and microbiological aspects of quality of all the products and processes. The chemical testing of products at various stages of manufacturing is done by the Chemical laboratory of Quality Control Department. The Microbiological testing of Products and environmental aspects is done in the Microbiology laboratory. Specified testing procedures are followed to perform all tests. The results are sent to QAD for decisions. The complete testing records are maintained in the relevant Registers. Analytical Lab Equipments & Instruments, High performance Liquid Chromatography (HPLC), Ultra Violet/Visible Spectrophotometer, Atomic Absorption, Conductivity meter, pH Meter weighing Balances, Moisture Analyzer, Melting point Apparatus, Polarimeter, Stability Chamber, Centrifuge Machine, Vacuum Pump, Sonication Bath, Digital Hardness Apparatus, Disintegration Apparatus, Hot Plate, Magnetic Stirrer, Friability Apparatus, Dissolution Apparatus, Digital Burette and Viscometer.

QUALITY EQUIPMENTS: Microbiologic laboratories Auto Clave Laminar Flow Cabinet Cooled Incubator, Hot Incubator, Rafratometer, Binocular Microscope, Air Velocity Meter, Biological air sampler, Laser particles. Stability Chamber purpose is to provide evidence on how the Quality of a Drug Substance Varies with time under the influence of a variety of Environmental conditions. Accelerated stability studies (40 Degree Centigrade, 65% humidity for 3 to 6 months) long term stability studies (30 Centigrade, 50% Humidity for 2 to 3 years) distinctive instruments.

UV – VISIBLE SPECTROPHOTOMETER: It is used to provide protocols for performing measurements on UV-Visible Spectrophotometer. It is also used in quantitative measurements of different raw materials.

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY: High Performance Liquid Chromatography is use to provide protocols for performing assay measurements of different compounds by chromatographic techniques. The raw materials use and finished products are testing using HPLC.