Quality Assurance

Quality Assurance

Our quality assurance ensures our internal standards are upheld. We believe in quality and have a dedicated department with a primary focus in maintaining high standards. We maintain a quality management system in accordance with the International Organization for Standardization (ISO) 9001:2008, ensuring our continued effectiveness.

We uphold good manufacturing practice (GMP) requirements and our GMP compliance team is responsible for encouraging good practices. This allows us to deliver value and satisfaction to our principals. 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 Assurance department and Quality Control department.

Quality Assurance 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 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. 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 product.