SeerPharma has a long-standing reputation for helping pharmaceutical and medical device companies establish new or upgrade existing GMP manufacturing facilities. The team is currently engaged in multiple facility projects across the APAC region, working on complex facility projects involving the manufacture of:
A start-up biotechnology company focused on combining stem cells and immunotherapy to eliminate cancer, has engaged with SeerPharma to help develop a Quality Management System. The company’s revolutionary technology is looking to enhance a patient’s own immune system to tackle cancer.
As a Pharmaceutical company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from regulatory inspections in the PIC/S, TGA and FDA GMP environment.
As a Medical Device company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from quality (management) system inspections and audits against FDA 21 CFR Part 820 and ISO 13485.
When handling a pharmaceutical or medical device, it is imperative in the eyes of the regulator, such as the TGA or FDA, that people within your organisation are assigned appropriate roles and responsibilities. One of the most important roles is that of the Authorised Person, who is responsible for authorising steps of the manufacturing process,...
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