GMP audits and inspections

We conduct GMP audits/inspections to verify the compliance status of the manufacturer and suggest improvements. The types of audits that are covered here include gap analysis audits and mock inspections to assess the preparedness 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 effectiveness of GMP implementation programmes. This is done by adopting a ‘partnering’ approach with the firm and placing emphasis 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 ethical principles.

This helps the firm in assuring consistent quality and adherence to GMP across the entire supply chain i.e. from procurement to distribution, complaint evaluation and product quality reviews.We also carry out audits to the assist the firms in establishing feasibility of third party manufacturers, qualifying vendors of raw and primary packaging material.