GMP Audits & 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.
- Manufacturers of Active Pharmaceutical Ingredients ( API ) and intermediates
- Manufacturers of Finished Dosage Forms ( FDF )
- Manufacturers of Cosmetics
- Manufacturers of Medical devices
- Food manufacturers for food GMP and HACCP compliance
- Excepient manufacturers and
- Packaging material manufacturers
- Health check of the quality system
- Timely remedial action
- Aids in improved risk assessment leading to patient confidence
- Preparation tool for regulatory inspection
- Training of the team to face audits successfully
- Expanding the quality horizon beyond self-inspection
- Cost effective vendor management and reliable third party identification
- Better resource utilization and
- Sustainable compliance