Pharmaceutical GMP Audits and Self-Inspections

A chemist with over 35 years of experience in the pharmaceutical industry, Graham Clapperton has experience interfacing with both FDA and MHRA in global projects. He has been a Qualified Person for over 25 years and has held a number of roles within the 3M Health Care and 3M Drug Delivery Systems (DDS) organizations including research and development, quality control, quality assurance and supply chain operations.

Mr. Clapperton has significant experience as an auditor, having been involved in many different types of audits both as an auditor and as an auditee. He is a pragmatic and practical QA professional with significant global and European experience during his career with 3M, culminating in his role as European Quality Manager for the 3M DDS Division for over 10 years. He was also heavily involved in helping globalize the 3M DDS quality organization. He is also experienced in Lean manufacturing and has been involved in several major organizational restructuring projects.

• His areas of expertise include:
• Dosage forms: Medicinal inhalers (including canister and valve manufacture), tablets, capsules, liquids and creams, plus limited experience in transdermals and injectables  
• Functional areas: Research and development, analytical chemistry, quality control, quality assurance, own brand and contract manufacturing
• QA knowledge: Qualified Person under transitional process, corporate auditing, vendor auditing, regulatory audit management (FDA, MHRA, etc.), ISO 9000, quality systems development and management, and training
• Six Sigma methodology
• Leadership of organizational and culture change processes

Mr. Clapperton is a Fellow of the Royal Society of Chemistry, a Chartered Chemist and a European Chemist.

Rachel Susan Carmichael has over 20 years’ experience of pharmaceutical manufacture, control and quality management including nearly 11 years as a GMDP Inspector for the UK Competent Authority, 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.

Ms. Carmichael is 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 of 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.

Her areas of recognized expertise include:

• Manufacture and packaging of oral solid dosage forms
• Good Distribution Practice
• Good Manufacturing Practice
• Blood industry: Blood establishments, hospital blood banks and plasma collection sites
• Data integrity
• Pharmaceutical law

Samantha Clack is a quality consultant and Qualified Person with over 20 years of experience in technical, quality and managerial roles in parenteral, solid dose and topical dosage form manufacture.  She is an ISO Lead Auditor and also the trainee QP coordinator and secretary for the Pharmaceutical Quality Group (PQG).

She started her career with Patheon Ltd (formerly Hoechst Marion Roussel) in Swindon, where she worked in technical and managerial roles in manufacturing and packaging. With Patheon she gained experience in a wide range of dosage forms including sterile powder filling, sterile and non-sterile ointment filling, creams, liquids and suppository manufacture and filling, tableting and packaging.

She next worked for Eli Lilly & Company Limited as a senior quality assurance associate in the Corporate Quality Assurance division. Her responsibilities included auditing Lilly’s third-party contractors and suppliers covering parenteral, biotech, liquids and creams, solid dose and API dosage forms as well as excipients, warehousing, marketing affiliates and clinical trial sites. The role also involved providing training in quality management systems for Lilly affiliates worldwide.

Ms. Clack then joined Eisai Manufacturing Limited as QA Manager of Marketed Products, concentrating on the start-up of a new solid dose manufacturing and packaging facility, implementing and developing quality systems and processes as well as performing batch disposition activities for products manufactured at contract manufacturers. She played a key role in the management of regulatory inspections, cumulating in the site gaining its full manufacturing license.

Her recognized areas of expertise include :

• Microbiology
• Solid dose and sterile product manufacture and packaging
• Quality management systems
• Qualified Persons training
• Auditing of excipient, API, finished dosage form and primary and secondary packaging facilities worldwide

Liz Allanson is a pharmacist by profession and has a special interest in quality management and leadership skills. She spent almost 19 years as a GMP inspector with the UK MHRA, primarily as one of the senior managers in the MHRA Medicines Inspectorate. Her last position with MHRA was managing the GMP inspection team.

Ms. Allanson is eligible to act as a Qualified Person and is a registered IRCA lead auditor. Her areas of expertise include:

• EU GMP pharmaceutical legislation and regulatory expectations, including requirements for investigational medicinal products
• GMP and GDP compliance
• Quality management systems
• Clinical trial manufacture/packaging and QP release
• Auditing and mock regulatory GMP inspections
• Supply chain management

David Selby has 40 years of experience in the pharmaceutical industry, primarily in roles requiring knowledge of GMP and the regulatory environment. He is eligible to act as a Qualified Person under EU Law. With this breadth of experience, Dr. Selby is currently focused on auditing, risk management, pharmaceutical quality systems and all aspects of validation and qualification. He helps companies prepare for regulatory inspections (both EU and FDA) and has developed the IRCA Accredited Pharmaceutical GMP auditing course.

Dr. Selby spent several years in research and development at Glaxo, before moving into international GMP compliance auditing and then becoming responsible for the manufacture of tablets and then antibiotics at the Glaxo site in County Durham, UK. Subsequently he occupied the role of Site Quality Assurance Manager and most recently was the Site Manager.

Mike Halliday has extensive pharmaceutical manufacturing management and QA experience, gained over 20 years working for three major international pharmaceutical manufacturers. Before joining NSF in 2003, he was Associate Director, Global Audit and Compliance for Wyeth Europa. He was also previously a partner at David Begg Associates (DBA).

Mr. Halliday is eligible to act as a Qualified Person and is an honorary lecturer at the University of Strathclyde.

He has broad experience in the manufacturing management and QA of a wide range of sterile and non-sterile dosage forms and is fully conversant with current EU and FDA GMP regulations and requirements. He has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers and specialist distributors in Europe, the Middle East, America and Asia Pacific.

Areas of recognized expertise include :

• QP training
• Packaging and labeling control
• GMP legislation
• API manufacture and control
• Auditing and self-inspection skills – Education of auditors
• Supply chain distribution