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Quality and System

Rakshit is committed to maintain best Quality Standards in Research and Manufacturing of Pharmaceutical products through periodic reviews and continual improvement of Quality Management System, and strive to enhance customer satisfaction

RAKSHIT STANDS FOR ASSURED QUALITY

  • Training is continuous process at Rakshit….at all levels
  • Our facilities are certified by USFDA, Japan PMDA, Korea FDA, CDSCO-India, GMP, WHO-GMP, EU –Written confirmation.
  • Stringent Quality checks and procedures in place at all levels of API manufacturing from raw materials sourcing to sales and after sales service.
  • The main objective for quality assurance and technical team of Rakshit is to carry out continual development of its process, procedures, people and products.
  • Quality Systems complies to ICH Q7 cGMP practices and requirements
  • Rakshit consciously works on In-process control, prevention of contamination, change control system, complaint, Recalls /rejections, System for controlling complaints and rejection and Regulatory support to customers.
  • Our philosophy is to create systems that are simple and based on good science and are in compliance with various regulatory authority requirements.

The systems at Rakshit:

Standard operating procedures (SOP’s) | Guidelines | Training | Documentation | Total quality management (TQM) | Quality Business Development (QBD)

ENVIRONMENT, HEALTH AND SAFETY

Rakshit is committed to:

  • Mitigate the environmental impact of its activities, products and services.
  • Protect and promote the health and well being of its employees
  • To equip, establish and operate its facilities to highest safety standards

Regulatory Compliance

Rakshit is fully committed to ensuring our manufacturing facilities comply with international regulations for current Good Manufacturing Practice (cGMP); GLPs and all locally applicable regulatory requirements.