Quality Management System (QMS) of MedRx is established in accordance with the principles of WHO and PICS guidelines. QMS describes the Quality Policy and technical aspects of Quality Assurance. It encompasses all activities necessary to generate, maintain and verify the quality of drugs.
The Quality Assurance of manufacturing plant consists of Quality Control, Quality Compliance and Quality Surveillance. The main tasks and duties of Quality Control have been described in the Quality Manual and relevant SOPs.
Quality Compliance is responsible for IPC, GMP co-ordination, training and monitoring the routine GMP checks and checking the batch record completion, cleaning of working place, line clearance, performance checks of balance & other equipment.
Quality Surveillance is responsible for the implementation of the QMS in different areas in collaboration with different departments. Quality Surveillance plays active role in conducting external and internal audits with their follow-ups.
Supply of raw materials are mainly obtained from approved manufacturer from European, USA, Japan, Korea, India and China. The Quality Control along with other appropriate departments are responsible for coordinating activity in their respective areas to
ensure that there is an assessment of all proposed changes and that approved changes are communicated to all affected parties. They are also responsible for change control procedures, documentation, evidence, continuous support and maintenance for implemented changes.
MedRx Quality Control lab is equipped with modern equipment to carry out quality control system.
“QC equipment are imported from Japan, USA, Germany, Romania, Italy and India etc.”
The `Site Validation Master Plan’ describes the strategy on qualification and validation covering Equipment Qualification, Process Validation, Cleaning Validation, Method Validation, System Validation, Personnel Validation etc.
We strictly follow the following basic facts of GMP practice:
- We must have written procedure
- We have to follow our written procedure
- We have to record our work
- We have to validate our work
- We have to maintain our facilities and equipment in proper state
- We must have education, training and experience to perform
- We must design and build proper facilities and equipment
- We have to maintain clean environment
- We must control our quality
- We have to periodically audit for compliance
We strictly maintain the correct specification like disintegration, dissolution, release pattern, site of release, hardness etc. during formulation of the medicines. These ensure optimum bioavailability and eventually efficacy of our products.
We strictly store the documents of our every manufacturing process. We have dedicated documentation room where only three designated personnel of the company have authorized access. Our documentation process is fully automated thus it is fast and secure.
Validation is continuous process to verify that our process are devoid of any deviation and error. Quality personnel are assigned to check and validate processes, methods and equipment. Dedicated personnel are assigned to carry out regular validation work.
Our labs are equipped with high tech machinery and equipment that provides more accurate data for analysis. We have developed software for controlling our overall operations. The system is automated in such a way that cannot be edited or modified. All the steps are recorded and stored ensuring complete security measure.