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Quality Assurance

Committed to conforming to National and Global Regulations on Quality.

At Ami Lifesciences, we have the requisite infrastructure and expertise to ensure proper regulatory approvals of our clients and competent authorities such as EUGMP, TGA, KFDA, UKMHRA, EDQM, ANVISA, COFEPRIS etc.

Our QA department ensures that every activity associated with the design, development, and manufacturing ( Purchase, Warehousing, Production, Quality Control, Release and Distribution) of Active Pharma Ingredients and intermediates are carried out in a systematic and approved manner in compliance with the regulatory and cGMP requirements.

Highlights of Our Q&AA and Regulatory Systems

  • Implementation of Standard Operating Procedures (SOP’s) and periodic review
  • Instrument and Equipment Qualifications
  • Process Validation and Method Validation
  • In process controls
  • Technology Transfer
  • Documentation Control
  • Audit of manufacturing facilities and auditing suppliers of the critical raw materials
  • Handling deviations, customer complaints, implementation of the corrective and preventive actions.
  • Capability to develop and file CTD DMF, US DMFs, CEP and other registrations required in the various markets.