THE CLIENT
GMP Healthcare had been providing the client, a global medicinal and medical device manufacturing company, with Qualified Person (QP) and Responsible Person (RP) services for several months when the client was informed of an unexpected Medicines and Healthcare product Regulatory Agency (MHRA) Good Distribution Practice (GDP) audit.
The audit was identified as high risk, due to non-compliance concerns, distribution of medicinal products to the export market was on hold pending the audit and the business was under extreme pressure. Intense support, planning and organisation were required to ensure a successful outcome.
THE PROJECT
GMP Healthcare has a wealth of experience in regulatory inspections and exceptionally high standards when it comes to Health Authority audit preparation. The client was therefore supported with the most dedicated resources and professional solutions available in the industry.
QP and RP assessments were carried out on the pharmaceutical quality management system, major and critical non-compliances were identified and a solution was put in place and executed within two months. The GMP Healthcare team spent a great deal of time liaising with the client, often working out of hours to accommodate different time zones, supporting the client with licence variations, mock audits, remediation of procedures and systems, consultation with the MHRA inspectors and classroom training for staff on the principles of GDP and several other QMS modules.
GMP Healthcare also hosted the audit to ensure that the MHRA inspector was happy with all the evidence and data provided.
THE OUTCOME
The GDP audit was successful and the client passed with no major observations, where a critical observation was expected.
The client was extremely satisfied and has maintained the relationship with GMP Healthcare, requesting further ongoing help with other requirements within the business.
This is a classic example of where GMP Healthcare went out of its way to exceed the client’s expectation, truly proving that our core values are embedded within the team (caring, knowledge, ownership, positivity and teamwork).
