A European multinational pharmaceutical manufacturer in China (Beijing), recently engaged SeerPharma to conduct a mock TGA GMP inspection in preparation for an impending TGA audit. The operations had been inspected by the TGA in the past.
SeerPharma has been engaged by multiple companies to conduct GMP audits in the Asia-Pacific region on behalf of Qualified Persons (QP) in Europe.
A leading sterile pharmaceutical manufacturer in India engaged SeerPharma to assist in responding to a recent TGA GMP audit. As part of its response to the TGA, the company requested SeerPharma to visit their site in Madhya Pradesh. SeerPharma was tasked to assess the clients’ sterile facilities, documentation, quality management system, risk...
Audit and Inspection Insights from a Former GMP Inspector
Things that you typically look out for when conducting a Good Manufacturing Practice (GMP) supplier or internal audit and typical observations you see during a GMP Inspection.
Pharmaceutical firms in India have turned to SeerPharma for assistance on matters of Quality Assurance and GMP compliance.
An Australian pharmaceutical company engaged SeerPharma to prepare them for a TGA and FDA GMP inspection. Their Engineers were relatively inexperienced in dealing with regulatory inspections and the company required them to gain experience quickly in preparation for the FDA’s arrival. SeerPharma were requested to perform a mock audit to help meet...