Compliance

• Quality Management Systems in R&D as well as Manufacturing Facility  in compliance to Domestic and International regulatory standards.
• Developmental Quality Assurance (DQA) and Quality assurance (QA) with dedicated team ensures all the activities are performed as per approved written procedures.
• Chromatographic instruments like HPLC’s and GC’s are installed with Open Lab CDS – 2.5+ version, are connected to the Server
• Non-chromatographic instruments like Particle Size Analyzer, Stability Chambers, UV spectrophotometer, FT-IR are connected to the server through qualified software’s,
• Qualified software’s are used for 21 CFR Part 11compliance.
• Documents generated at R&D and  Manufacturing Facility shall be reviewed and authorized by respective QA teams for integrity, accuracy and proficiency before sharing documents to internal Regulatory Team or Customers.
• Provide periodical training and evaluation to all employees on cGMP and other behavior based aspects to maintain high degree of Integrity.
• Efficient Document Archival and Retrieval system and procedures for easy and quick access.
• Adherence to Statutory requirements and stringent Safety Health and Environment measures.