A large multi-national medical device company received notice of deficiencies for their Australian facillity after repeated GMP audits from the Australian Therapeutic Goods Administration (TGA).
Unfortunately, due to the pressures of daily operations and the loss of key staff, the resources to address the deficiencies were unavailable.
With the deadline looming for their response to the audit findings, and the possibility that the TGA could demand that shipments cease, the company asked PharmOut to help respond to the notices of deficiencies and achieve sustainable compliance.
With only six months until the return of the TGA auditors, PharmOut quickly installed a Project Manager and several experienced TGA GMP compliance consultants.
They applied a 4 step process to resolve the deficiences:
When the TGA returned, six months after their last visit, the company successfully passed the audit. The people and processes that PharmOut installed within the company will ensure ongoing compliance, reducing the business risk to the company.