GMP Audits and Inspections

We conduct GMP audits/inspections to verify the acquiescence status of the manufacturer and recommend improvements. The types of audits that are sheltered here include gap analysis audits and mock inspections to assess the watchfulness level for GMP inspections. This also supplements the internal self-inspection and expectations of the regulatory agencies of an independent audit of QA department by external agency.

The objective is also to monitor the efficiency of GMP implementation programmes. This is done by adopting a ‘partnering’ approach with the firm and placing importance on sound science and current regulatory requirements. All information shall be treated as confidential and the mechanics of operation shall be based on transparency and principled principles.

We also carry out audits to the assist the firms in establishing feasibility of third party manufacturers, qualify vendors of raw and primary packaging material.

Coveragenifites

  • Manufacturers of Active Pharmaceutical ingredient ( API ) and intermediates
  • Manufacturers of Finished Dosage Forms ( FDF )
  • Manufacturers of Cosmetics
  • Manufacturers of Medical devices
  • Food manufacturers for food GMP and HACCP acquiescence
  • Expedient manufacturers and
  • Packaging material manufacturers

Advantages

  • Health check of the quality system
  • Timely remedial action
  • Aids in improved risk estimation leading to patient confidence
  • Preparation tool for regulatory inspection
  • Training of the team to face audit successfully
  • Expanding the quality horizon further than self-inspection
  • Cost effective vendor management and dependable third party identification
  • Better resource consumption and
  • Sustainable compliance