Compliance Monitor
The MHRA are currently running a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and are referred to the Inspection Action Group (IAG). Referral to the IAG occurs after a failed inspection that has resulted in the compliance escalation process being initiated.
During the pilot scheme, the MHRA will review referrals to the IAG and where these referrals are considered suitable, the company may be offered the option of using Compliance Monitors (CM) to oversee the implementation of an agreed Compliance Protocol (CP). This independent oversight from the Compliance Monitor will enable the company to focus on remediation of the corrective actions and augment the regulatory oversight of the MHRA.
The consultant at QualiPharm Consultancy has been deemed eligible by the MHRA to act as a Compliance Monitor (CM) in MHRA’s pilot compliance monitoring programme for GMP and GDP remediation supervision activities.
QualiPharm are based near Edinburgh in Scotland and can provide Compliance Monitor services to clients within the whole of the UK