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.
Quality Management System
A Quality Management System (QMS) is a collection of business processes focused on achieving your quality policy and quality objectives. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management.Quality Management System has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors. Of all Quality Management System regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both, and deals with quality and sustainability and their integration.
- 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 vendorExpanding the quality horizon beyond self-inspection
- management and reliable third party identification
- Better resource utilization
- Sustainable compliance