NSF Experts Deemed Eligible To Act As MHRA Compliance Monitors

Phil Rose and Rachel Carmichael from NSF have been deemed eligible by the MHRA to act as Compliance Monitors (CMs) in the MHRA’s pilot compliance monitor program for [GMP/GDP] remediation supervision activities.

The UK MHRA initiated a pilot scheme in April 2022 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) after an inspection that has resulted in the compliance escalation process being initiated.

The Compliance Monitor audit aims to reduce shortages in the supply of safe medicines, using risk-based supervision and monitoring. The process will also assist the MHRA in concentrating resources on delivery of the routine risk-based inspection program.

The pilot scheme will see the UK MHRA refer reviews to the IAG and, where relevant, offer the option of using Compliance Monitors (CMs), such as Phil Rose or Rachel Carmichael, to oversee the implementation of an agreed Compliance Protocol (CP). A company offered the CM oversight route may choose not to accept this and can continue with the routine IAG process.

Compliance Monitor oversight aims to enable the company to focus on remediation actions and to augment the regulatory oversight activities of the MHRA.

Both Phil Rose and Rachel Carmichael are experienced ex-MHRA regulators.

Phil Rose has over 20 years of experience in a wide range of roles within the pharmaceutical industry, from QC through to senior management and as a Qualified Person. Most recently, he worked as a lead senior GMDP inspector for the UK competent authority the MHRA, prior to joining NSF in June 2022. Within this role, he inspected some of the most complex cases globally against EU GMP and GDP in areas such as biologicals (including vaccines), steriles, non-steriles, ATMPs and specials. This included inspections on behalf of the EMA as well as leading joint inspections with the U.S. FDA. Mr. Rose was a member of the MHRA’s Compliance Management Team (CMT) and was the Inspectorate technical lead for biologicals and, previously, the technical lead for steriles. He was also a member of the Inspectorate’s cross-contamination group. Mr. Rose recently served as a key member of the MHRA’s Vaccine Task Force involved in the UK’s COVID-19 response.

Rachel Carmichael has over 20 years’ experience of pharmaceutical manufacture, control and quality management, including nearly 11 years as a GMDP inspector for the MHRA. This includes serving as the lead inspector representative within the MHRA for the transition from the Medicines Act to the Human Medicines Regulation, SI 2012 1916.

She is also eligible to act as a Qualified Person under the provisions of EU Directives and is a member of the Royal Society of Biology. She has wide-ranging experience inspecting against European Good Distribution Practice and Good Manufacturing Practice requirements in the UK, China, India and the U.S. to meet the associated quality standards for medicines (non-sterile and aseptic production, including radio pharmaceuticals) and the blood industry.