Outsourced Audit

Pharmaceutical regulation expects the industries to monitor, manage and ensure compliance of the entire Supply Chain, from incoming of goods to delivery of final products. Both Pharmaceutical suppliers and manufacturer are required to conduct routine quality audits.

With increasing size of export market for medicinal products especially from countries like India to US, Europe and Australasia, supply chain network is getting more and more complicated demanding tighter control to maintain and be compliant to the cGMP requirement. Thus off-shore audit and vendor management could become quite expensive thus requiring specialized vendor management consultants who can do the job for the overseas clients at a much lower cost.

Our cGXP audit team is made up of specialized QA experts from the cGXP environment with years of experience and understanding of the overseas regulatory environment, especially in what the FDA / TGA / MHRA auditors are looking for. Our auditor helps you to identify the areas where there is a shortfall of compliance thus helping you to respond to the need for the transparency of your business models and make your processes sustainability. We assure you from our service in optimizing time and money.

Our audit service include,

• Total compliance of entire cGXP requirement
• Developing site cGMP and cGLP strategy
• Mock FDA/TGA/MHRA/ ISO inspection
• Gap Analysis and Mitigation Plan
• Validation Activities
• Audit to study the feasibility of third party manufacturer, qualifying vendors of raw materials and packaged materials