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.
Preparation for the on-site mock audit included a review of the company’s responses to previous regulatory inspection findings. SeerPharma initially conducted a remote review of the operations' Quality Management System (QMS) documentation and electronic manufacturing records.
This was then followed by a full on-site mock TGA GMP Inspection of the manufacturer's facility and operations in Beijing. Two (2) Consultants from SeerPharma spent time on-site conducting a mock GMP audit against relevant Annexes of the PIC/S Guide to GMP for Medicinal Products version 15 (PE009-15), as adopted by the TGA, as well as advising the company’s preparation for PIC/S GMP Guide version 17 (PE009-17) Annex 1 compliance. SeerPharma assessed the company’s:
- Sterile Manufacturing Operations
- Assembling & Packaging
- Warehousing
- Chemical and Microbial Quality Control
- Computerised Systems
- Release for Supply
After conducting the mock GMP inspection, the team from SeerPharma spent further time on-site delivering training and advice to the client on how best to prepare for the impending TGA GMP audit.
SeerPharma has over 30 years of experience supporting manufacturers in preparing for regulatory GMP inspections from bodies such as the TGA, EMA and FDA.
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