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Revised GMP guidelines for Pharma in India

  1. The new guideline introduces pharmaceutical quality system, quality risk management, product quality review and validation of equipment and also suggests a change control system to evaluate all changes that may affect the production or quality of the product
  2. As per the revised rules, the companies will be needed to mandatorily maintain the drugs in a stability chamber, set the proper temperature and humidity, and carry out an accelerated stability test as well”
  3. The guidelines also state that, companies should have GMP-related computerized systems to ensure that there is no tempering of data related to the processes. Such GMP systems will prevent unauthorized access and changes to the data. Backups would also be created to ensure there is no loss of data
  4. In addition, the new schedule M also lists out the requirements for additional types of products, such as biological products, agents with radioactive ingredients or plant-derived products
  5. Also this gives the requirement for investigational products being manufactured for clinical trials
  6. The improved standards will ensure that pharmaceutical companies follow standard processes, quality control measures, and do not cut corners, improving quality of medicines available in India as well as sold in global market.
  1. Instituting the same quality across the industry
  2. Will improve the quality of drugs in the domestic markets
  3. It will help the govt., to ensure all the manufacturing units in country are at par with global standards
  4. And reduces the need of repeated inspections by different regulators
  5. It will make India a quality pharmaceutical hub of the world