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 assessments, CAPAs, and qualification documents to support their efforts to address concerns raised by the TGA.
SeerPharma was requested to assess and provide guidance on the clients’ approach to:
- Risk Management and the use of Risk Management tools
- Sterility Assurance, Product quality complaints, Investigations, Environmental and Microbial excursions
- Validation, Equipment qualification, Aseptic processing & movement, Cleaning & Sanitization practices, usage & qualification of disinfectants.
- Environmental monitoring qualification, Media fills and smoke studies
- Deviations and Investigations.
Separately, while in Indonesia, SeerPharma was engaged to provide guidance and assistance on-site during a regulatory GMP Inspection from the TGA.
SeerPharma had spent time earlier with the client providing guidance on responding to a previous TGA GMP audit. In addition, SeerPharma provided training to the client on how to conduct itself during a regulatory GMP inspection.
SeerPharma has over 30 years of experience supporting clients with regulatory GMP inspections from health authorities such as the TGA, US FDA and EMA.
Contact us, should you require support in preparing for, conducting, or responding to GMP inspections.