About us
Claire Glenister
Claire has worked within the pharma sector for the last 24 years. The first 15 years of her career were spent working in a variety of roles for a global manufacturer. These roles included Quality Manager for both manufacturing and non-manufacturing areas of the business and, latterly, as the Site Compliance Auditor which involved undertaking regular audits of all areas related to the manufacturing and testing of respiratory and oral solid dose products. This included the introduction of new products fed through from the Research and Development arm of the business. She has significant experience in areas of manufacturing, particularly QMS implementation, Quality Assurance and project management .
In 2013, Claire joined the MHRA as a GDP inspector. The role involved inspecting the full portfolio of UK WDA holders and respective business models, including challenging and non-compliant sites. She has an excellent understanding of how the EU GDP Guidelines and the HMR 2012 should be applied to a companies operations and specialises in the development of appropriate QMS’s for businesses.
Claire is also experienced in presenting to large audiences as part of her role in the MHRA when presenting at the annual symposia. Along with Peter, she has also run well-received training sessions and workshops on QMS in GDP for the PIC/S programme with an international audience of regulatory inspectors.
Claire’s time with the agency covered the implementation of both the EU GDP Guidelines in 2013, the Falsified Medicines Directive in 2019 and the Covid-19 response in 2020. Claire became Operations Manager for GDP at the MHRA, responsible for her team and a number of business areas including the operational delivery of the inspection plan for the UK whilst still carrying out complex inspections of larger companies and sites.
Claire holds the following professional qualifications and accolades:
Practitioner status with the Chartered Quality Institute (PCQI)
BSc (Hons) in Business Administration
MHRA GDP Inspector training course and certification
Quality Assurance Management Development Programme (internal to GSK)
ISO 9000:2000 trained
RSSL Auditor/Lead Auditor trained
GlaxoSmithKline Certified Auditor
PRINCE 2 Practitioner
City and Guilds NVQ level 2 certificates in ‘Facilitating learning through individual coaching (C25) and ‘Conducting non competence based assessments’ (D21)
CQI module D1 – Quality Principles
CQI module D2 - Quality Management
CQI module D3 – Quality Tools and Techniques
Peter Coombs
Peter has worked within the GDP environment for 20 years, initially as a GDP Inspector and, since 2011, as an Operations Manager for GDP and a Senior Inspector. In these roles he has developed a comprehensive understanding of the UK GDP sector and the application of the regulatory requirements within it.
Peter joined the MHRA in 1993 and worked in a number of key roles for the, then, MCA prior to joining the Inspectorate in 2002. In particular he led a team which conducted an in-depth study and report into the use and potential health impacts of the widespread use of Traditional Chinese Medicines in the UK. This report informed the regulatory approach in this sensitive but complex area.
Peter also managed the MHRA’s prosecution team and became extremely experienced in the complexities of medicines law and the variety and potential seriousness of violations, which included being an expert witness.
With a reputation as a highly experienced and approachable inspector, he has presented both nationally and internationally for the MHRA on key areas within GDP.
Peter has extensive experience across various construction and building management roles which required effective project management and people management skills in addition to extensive knowledge of the areas including infrastructure, mechanical and electrical engineering, aspects of building design and interior layouts. Peters previous experience in building design, engineering and management lends itself perfectly to being able to advise on the correct facilities for the compliant storage of pharmaceutical products in line with GDP regulations.
Peter has experience covering a period of 35 years obtained within the pharmaceutical and construction/engineering sectors and has a proven track record of identifying solutions to complex issues commensurate to the level of patient risk.
Peter holds the following professional qualifications and accolades:
Successful completion of MCA (MHRA) GDP inspector training course and certification
ISO 9001 : 2000 qualified auditor
Member of the International Society of Pharmaceutical Engineers
Successful completion of a large number of company and Government led courses including Project Management, Quality Management, Risk Management and Health & Safety Auditing
Hannah Currey
Hannah is a results-oriented pharmaceutical professional with 12 years experience in GDP Regulatory within the Pharmaceutical industry. As an experienced Responsible Person (MHRA Cogent trained), Hannah has a proven track record of building and upgrading Quality Management Systems to ensure compliance with regulatory standards, driving business development and managing large teams and projects. Her expertise has resulted in successful MHRA inspections and founding and managing her own pharmaceutical wholesale operation for a number of years.
Hannah has exceptional administrative and organisational skills working on MHRA licenced sites and and extensive experience in the application of GDP within multiple operational models. With excellent communication skills, both verbal and written, Hannah is recognised for her extremely strong work ethic and dedication to continuous professional development to ensure her understanding of industry standards is current.
Hannahs recent professional accomplishments include the management and deployment of a Team Development Program to improve compliance and performance, leading the implementation of export trade models for existing and start-up pharmaceutical wholesalers and creating MHRA aligned procedures and processes for new businesses and leading them through the WDA application and inspection process. She also has significant experience in PLPI and PV requirements and contract warehousing.